FDA Safety Alerts
for Drugs and Medication-Related Medical Devices

 

Drugs and Therapeutic Biological Products

Local Anesthetics, Continuously Infused
(posted 11/13/2009)

FDA notified healthcare professionals of 35 reports of chondrolysis (necrosis and destruction of cartilage) in patients given continuous intra-articular infusions of local anesthetics with elastomeric infusion devices to control post-surgical pain. The local anesthetics (with and without epinephrine) were infused for extended periods of time (48 to 72 hours) directly into the intra-articular space using an elastomeric pump. Joint pain, stiffness, and loss of motion were reported as early as the second month after receiving the infusion. In more than half of these reports, the patients required additional surgery, including arthroscopy or arthroplasty (joint replacement).

Local anesthetics are approved as injections for the production of local or regional anesthesia or analgesia. The approved drug labels for local anesthetics do not include an indication for continuous intra-articular postoperative infusions or use of infusion devices, such as elastomeric pumps. The FDA has not cleared any infusion devices with an indication for use in intra-articular infusion of local anesthetics. Health care professionals are encouraged to follow the instructions for use of elastomeric infusion devices, and to not use these devices for continuous intra-articular infusion of local anesthetics after orthopedic surgery.

This notice provides further management considerations for healthcare professionals, information for patients, a data summary of the 35 reports, and references.

Dexferrum (iron dextran injection) - labeling change
(posted 10/16/2009)

American Regent and FDA notified healthcare professionals that anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection. The Boxed Warning has been modified to recommend administering a test dose prior to the first therapeutic dose and observing for signs or symptoms of anaphylactic-type reactions during administration of Dexferrum. Fatal reactions have followed the test dose of iron dextran injection, even in situations where the test dose was tolerated. Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions. It is recommended that resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions be readily available during Dexferrum administration.

Relenza (zanamivir) Inhalation Powder
(posted 10/9/2009)

GlaxoSmithKline (GSK) and FDA notified healthcare professionals of a report of the death of a patient with influenza who received Relenza (zanamivir) Inhalation Powder which was solubilized and administered by mechanical ventilation. Relenza (zanamivir) Inhalation Powder is not intended to be reconstituted in any liquid formulation and is not recommended for use in any nebulizer or mechanical ventilator.

GSK is aware that Relenza Inhalation Powder is being removed from its FDA-approved packaging and dissolved in various solutions for the purpose of nebulizing zanamivir for inhalation by patients with influenza who are unable to take oral medications or unable to inhale Relenza Inhalation Powder using the Diskhaler. Relenza or zanamivir for nebulization have not been approved by the FDA. The safety, effectiveness, and stability of zanamivir use by nebulization have not been established.

Relenza Inhalation Powder should only be used as directed in the prescribing information by using the Diskhaler device provided with the drug product. Relenza Inhalation Powder is a mixture of zanamivir active drug substance and lactose drug carrier. This formulation is not designed or intended to be administered by nebulization. There is a risk that the lactose sugar in this formulation can obstruct proper functioning of mechanical ventilator equipment.

Heparin: Change in Reference Standard
(posted 10/1/2009)

FDA notified healthcare professionals and patients of a change to heparin, effective October 1, 2009, which will include a new reference standard and test method used to determine the potency of the drug and able to detect impurities that may be present in heparin. The change, which will also harmonize the USP unit dose with the WHO International Standard unit dose, will result in approximately a 10% reduction in the potency of the heparin marketed in the United States.

This may have clinical significance in some situations, such as when heparin is administered as a bolus intravenous dose and an immediate anticoagulant effect is clinically important. Healthcare providers should be aware of the decrease in heparin potency as they monitor the anticoagulant effect of the drug; more heparin may be required to achieve and maintain the desired level of anticoagulation in some patients.

There will be simultaneous availability of heparin manufactured to meet the “old” and “new” USP monograph, with potential differences in potency. Products using the new “USP unit” potency definition are anticipated to be available on or after October 8. FDA is working with the manufacturers of heparin to ensure that an appropriate identifier is placed on heparin made under the new USP monograph. Most manufacturers will place an “N” next to the lot number. FDA is also working with the heparin manufacturers to study the impact of this variation in potency and will make the results available when the studies have concluded.

Tamiflu (oseltamivir) for Oral Suspension: Potential Medication Errors
(posted 9/24/2009)

FDA issued a Public Health Alert to notify prescribers and pharmacists about potential dosing errors with Tamiflu (oseltamivir) for Oral Suspension. U.S. health care providers usually write prescriptions for liquid medicines in milliliters (mL) or teaspoons, while Tamiflu is dosed in milligrams (mg). The dosing dispenser packaged with Tamiflu has markings only in 30, 45 and 60 mg. The Agency has received reports of errors where dosing instructions for the patient do not match the dosing dispenser. Health care providers should write doses in mg if the dosing dispenser with the drug is in mg. Pharmacists should ensure that the units of measure on the prescription instructions match the dosing device provided with the drug.

Promethazine Hydrochloride Injection
(posted 9/16/2009)

FDA notified healthcare professionals that a Boxed Warning is being added to the prescribing information for Promethazine Hydrochloride products, describing the risks of severe tissue injury, including gangrene, requiring amputation following intravenous administration of promethazine. The Boxed Warning will remind practitioners that due to the risks of intravenous injection, the preferred route of administration is deep intramuscular injection and that subcutaneous injection is contraindicated.

Perivascular extravasation, unintentional intra-arterial injection and intraneuronal or perineuronal infiltration of the drug may result in irritation and tissue damage. Healthcare professionals should be alert for signs and symptoms of potential tissue injury including burning or pain at the site of injection, phlebitis, swelling, and blistering.

GDH-PQQ Glucose Monitoring Technology: possibility of falsely elevated blood glucose results
(posted 8/13/2009)

FDA notified healthcare professionals of the possibility of falsely elevated blood glucose results when using GDH-PQQ glucose test strips on patients who are receiving therapeutic products containing certain non-glucose sugars. These sugars can falsely elevate glucose results, which may mask significant hypoglycemia or prompt excessive insulin administration, leading to serious injury or death.

GDH-PQQ glucose monitoring measures a patient’s blood glucose value using methodology that cannot distinguish between glucose and other sugars. Certain non-glucose sugars, including maltose, xylose, and galactose, are found in certain drug and biologic formulations, or can result from the metabolism of a drug or therapeutic product. The FDA Public Health Notification provides a list of GDH-PQQ Glucose Test Strips and recommends that healthcare practitioners avoid using GDH-PQQ glucose test strips in healthcare facilities or take steps to never use them on patients receiving interfering substances.

FDA encourages the voluntary reporting of any medical device adverse events related to glucose meters or glucose test strips that do not meet the requirements for mandatory reporting. Adverse events should be reported to the FDA's MedWatch Adverse Event Reporting program online, by phone [1-800-332-1088], or by returning the postage-paid FDA Form 3500 by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].

Dextroamphetamine, Amphetamine 20 mg Tablets (Barr Laboratories) recall
(posted 8/13/2009)

Barr Laboratories, Inc. issued a voluntary recall of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of a Single Entity Amphetamine Product) 20 mg Tablets, 100 count bottles, lot number 311756. The product is being recalled because the affected lot may contain some tablets exceeding weight requirements which may lead to super-potent tablets.

Clinically significant adverse reactions to a supratherapeutic dose could include cardiovascular, neurologic, psychiatric and gastrointestinal reactions. Customers who have this lot in their possession are instructed to cease using the product and return it to their pharmacy/distributor.

Colchicine (marketed as Colcrys)
(posted 7/30/2009)

FDA notified healthcare professionals of the approval of the first single-ingredient oral colchicine product, Colcrys, for the treatment of familial Mediterranean fever (FMF) and acute gout flares and of two previously uncharacterized safety concerns associated with the use of colchicine. Oral colchicine has been used for many years as an unapproved drug with no FDA-approved prescribing information, dosage recommendations, or drug interaction warnings.

FDA analyzed safety data for colchicine from adverse events reported to the Agency, the published literature, and company-sponsored pharmacokinetic and drug interaction studies. This analysis revealed cases of fatal colchicine toxicity reported in certain patients taking standard therapeutic doses of colchicine and concomitant medications that interact with colchicine, such as clarithromycin. These reports suggest that drug interactions affecting the gastrointestinal absorption and/or hepatic metabolism of colchicine play a central role in the development of colchicine toxicity. Data submitted supporting the safety and efficacy of Colcrys in acute gout flares demonstrated that a substantially lower dose of colchicine was as effective as the higher dose traditionally used. Moreover, patients receiving the lower dose experienced significantly fewer adverse events compared to the higher dose.

Based on this information, FDA has included important safety considerations in the approved prescribing information to assure safe use of Colcrys and is providing background information, a data summary and recommendations in this alert.

Recall: Prevnar Pneumococcal 7-valent Conjugate Vaccine, Wyeth
(posted 7/16/2009)

Wyeth is voluntarily recalling a lot of Prevnar®, Pneumococcal 7-valent Conjugate Vaccine, single dose pre-filled syringes. During a routine physical reconciliation of Prevnar® pre-filled syringes, Wyeth determined that a portion of a bulk lot of pre-filled syringes, which was not intended for commercial use, was inadvertently packaged and distributed with commercial product under Lot D50002. The product distributed as Lot D50002 met Wyeth’s quality acceptance criteria. Although some of the units of Lot D50002 were not intended for the commercial market, Wyeth performed a medical assessment and has concluded that the affected syringes present no health or safety risk to patients and that there is no need to revaccinate.

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Prevnar pneumococcal 7-valent Conjugate Vaccine (Diptheria CRM197Protein)

0.5 mL single dose pre-filled syringe (10 per package)

NDC: 0005-1970-50 (10’s)/0005-1970-49 (Singles)

Lot Number: D50002

Expiration Date: February 28, 2011

Teva Pharmaceuticals USA issues a voluntary user-level nationwide recall
(posted 7/16/2009)

Teva Pharmaceuticals USA is initiating a voluntary recall of Propofol Injectable Emulsion 10 mg/mL 100 mL vials, lot numbers 31305429B and 31305430B. The product lots identified are being recalled due to the presence of elevated endotoxin levels in some vials within these lot numbers.

Teva has been notified of 41 propofol-treated patients who experienced post-operative fever, chills and other flu-like symptoms. Based on available information it appears that all febrile or flu-like reactions were self-limiting with spontaneous resolution.

Adverse health effects, such as fever, chills, or rigors, are possible with exposure to product with elevated levels of endotoxins. Serious adverse effects, such as disseminated intravascular coagulopathy, acute respiratory distress syndrome, shock, and death, are possible with exposure to product with high endotoxin levels.

For use as an anesthetic agent, propofol should be used only by professionals trained in the administration of general anesthesia. For sedation of intubated, mechanically ventilated patients in the Intensive Care Unit, propofol should be administered only by persons skilled in the management of critically ill patients.

Customers who have Propofol lots 31305429B and 31305430B in their possession are instructed to cease using the product and return it to their distributor.

Teva Pharmaceuticals USA is voluntarily recalling the aforementioned lots. FDA and CDC have been apprised of this action.

Consumers with questions may contact 1-866-262-1243 from 8:00 am – 8:00 pm EDT Monday – Friday.

Any adverse reactions experienced with the use of this product should also be reported to the FDA’s MedWatch Program by phone at 1-800 FDA-1088; by fax at 1-800-FDA-0178; by mail at MedWatch, HF-410, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Immunosuppressant Drugs: Required Labeling Changes
(posted 7/14/2009)

The FDA is requiring the makers of certain immunosuppressant drugs to update their labeling to reflect that immunosuppressed patients are at increased risk for opportunistic infections, such as activation of latent viral infections, including BK virus-associated nephropathy. These immunosuppressant drugs are used to protect against the rejection of certain organ transplants. The association of BK virus-associated nephropathy has previously been reported for another immunosuppressant drug, tacrolimus (marketed as Prograf). Monitoring for this serious risk and early intervention by the health care provider is critical. Adjustments in immunosuppression therapy should be considered for patients who develop BK virus-associated nephropathy.

FDA is continuing to review the safety of immunosuppressant drug products used in renal transplantation. The FDA urges both healthcare professionals and patients to report side effects from the use of immunosuppressant drug products to the FDA's MedWatch Adverse Event Reporting program.

Brookstone Pharmaceuticals Issues a Voluntary Recall
(posted 7/14/2009)

Brookstone Pharmaceuticals, LLC, Alpharetta, GA has initiated anationwide voluntary recall of all lots of Concentrated Acetaminophen Drops (NDC#42192-504-16) in 16 ounce (473 ml) bulk containers. This 16oz container is comparableto the size generally used to package regular strength acetaminophen liquid preparations.This aspect of the product coupled with the absence of an integrated dosage deliverydevice is a contributing factor to possible dosing errors, especially inadvertentoverdosing. Brookstone has distributed 344 bottles nationally and has donated 5301bottles to charity for international distribution.

Over dosage of acetaminophen may result in liver toxicity, kidney damage, and blooddisorders. FDA is aware of several medication error reports that document lifethreateningor fatal adverse events in children less than three years of age, due toconfusion associated with the concentrated versus regular strength acetaminophen liquid.Also, in a recent FDA advisory panel, it was recommended that one of the two strengthsof acetaminophen should be removed from the market due to possible confusion whichcould result in overdosing.

Brookstone’s concentrated acetaminophen contains acetaminophen 80 mg/0.8 mL.Regular strength acetaminophen elixir contains 160 mg/5 ml. The firm is recalling itsproduct to the consumer level as a cautionary measure to minimize any confusion andpotential risk to patients from dosing errors.

Brookstone Pharmaceuticals has notified customers that it has voluntarily stoppedmanufacturing and shipping Concentrated Acetaminophen Drops in bulk containers andhas also advised customers (wholesalers and hospitals) to quarantine and hold the productfor return to Brookstone Pharmaceuticals for a full refund. Customers with questionsabout the recall may contact Brookstone Pharmaceuticals, LLC at 1-800-541-4802,option 2. Brookstone has not received any adverse events associated with this product butdue to recent advisory panel concerns, Brookstone has taken voluntary action.

The recalled drops were manufactured by Pharmaceutical Associates, Inc. This recall isbeing conducted with the knowledge of the Food and Drug Administration.

Customers who have this product in their possession should stop using it immediately.Any adverse events that may be related to the use of this product should be reported tothe FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

MedWatch June 2009 Safety Labeling Changes
(posted 7/11/2009)

The MedWatch June 2009 Drug Safety Labeling Changes posting includes 31 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.

The "Summary Page" provides a listing of drug names and safety labeling sections revised. Clicking on a drug product name in the Summary View will take you to the "detailed view" page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections.

The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections: Prometrium (progesterone), Reglan (metoclopramide), Coreg (carvedilol), Prandin (repaglinide), Videx (didanosine), Amaryl (glimepiride), Aristospan (triamcinolone hexacetonide injectable suspension, USP), Cancidas (caspofungin acetate), CellCept (mycophenolate mofetil), Combivent (ipratropium bromide and albuterol sulfate), Coreg CR (carvedilol phosphate), Patanase (olopatadine hydrochloride), Rocephin (cefTRIAXone sodium), Strattera (atomoxetine hydrochloride)

Propoxyphene-containing Products
(posted 7/7/2009)

FDA notified healthcare professionals that it is taking several actions to reduce the risk of overdose in patients using pain medications that contain propoxyphene because of data linking propoxyphene and fatal overdoses. The agency will require manufacturers of propoxyphene-containing products to strengthen the label, including the boxed warning, emphasizing the potential for overdose when using these products and to provide a medication guide to patients stressing the importance of using the drugs as directed.

FDA is requiring a new safety study assessing unanswered questions about the effects of propoxyphene on the heart at higher than recommended doses. Findings from this study, as well as other data, could lead to additional regulatory action. To further evaluate the safety of propoxyphene, FDA plans to work with several groups including the Centers for Medicare & Medicaid Services and the Veterans Health Administration to study how often the elderly are prescribed propoxyphene instead of other pain relievers and the difference in the safety profiles of propoxyphene compared to other drugs.

Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics)
(posted 7/1/2009)

FDA notified healthcare professionals and patients that it has required the manufacturers of the smoking cessation aids varenicline (Chantix) and bupropion (Zyban and generics) to add new Boxed Warnings and develop patient Medication Guides highlighting the risk of serious neuropsychiatric symptoms in patients using these products. These symptoms include changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior, and attempted suicide. The added warnings are based on the continued review of postmarketing adverse event reports for varenicline and bupropion received by the FDA. These reports included those with a temporal relationship between the use of varenicline or bupropion and suicidal events and the occurrence of suicidal ideation and suicidal behavior in patients with no history of psychiatric disease.

Healthcare professionals should advise patients to stop taking varenicline or bupropion and contact a healthcare provider immediately if they experience agitation, depressed mood, and any changes in behavior that are not typical of nicotine withdrawal, or if they experience suicidal thoughts or behavior.

Cefepime (marketed as Maxipime) Update of Ongoing Safety Review
(posted 6/17/2009)

FDA notified healthcare professionals that it has finished its analysis of a possible risk of higher death with cefepime, an antibiotic, following publication of a study that suggested a higher rate of death in patients treated with this drug, as compared to patients treated with similar drugs. FDA reviewed this study data and conducted additional analyses based on additional data, including data submitted by Bristol Meyers Squibb. FDA has determined that the data do not indicate a higher rate of death in cefepime-treated patients. Cefepime remains an appropriate therapy for its approved indications. FDA will continue to review the safety of cefepime. As part of this ongoing review, both FDA and Bristol Meyers Squib are conducting separate analyses of death potentially associated with cefepime, using hospital drug use data. The results of these analyses likely will be reported in approximately one year.

Zicam Cold Remedy Nasal Products
(posted 6/16/2009)

FDA notified consumers and healthcare professionals to discontinue use of three Zicam Nasal Gel/Nasal Swab products (Cold Remedy Nasal Gel, Cold Remedy Nasal Swabs, and Cold Remedy Swabs, Kids Size) sold over-the-counter as cold remedies because they are associated with the loss of sense of smell that may be long-lasting or permanent. The FDA has received more than 130 reports of loss of sense of smell associated with the use of the three Zicam products. In these reports, many people who experienced a loss of smell said the condition occurred with the first dose; others reported a loss of the sense of smell after multiple uses of the products. People who have experienced a loss of sense of smell or other problems after use of the affected Zicam products should contact their health care professional. The loss of sense of smell can adversely affect a person’s quality of life, and can limit the ability to detect the smell of gas or smoke or other signs of danger in the environment.

Stimulant Medication in Children with AD/HD - Communication about an Ongoing Safety Review
(posted 6/15/2009)

FDA notified healthcare professionals that it is providing its perspective on study data published in the American Journal of Psychiatry on the potential risks of stimulant medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children. This study, funded by the FDA and the National Institute of Mental Health (NIMH), compared the use of stimulant medications in 564 healthy children from across the United States who died suddenly to the use of stimulant medications in 564 children who died as passengers in a motor vehicle accident.The study authors concluded that there may be an association between the use of stimulant medications and sudden death in healthy children. Given the limitations of this study’s methodology, the FDA is unable to conclude that these data affect the overall risk and benefit profile of stimulant medications used to treat ADHD in children. FDA believes that this study should not serve as a basis for parents to stop a child’s stimulant medication. Parents should discuss concerns about the use of these medicines with the prescribing healthcare professional. Any child who develops cardiovascular symptoms (such as chest pain, shortness of breath or fainting) during stimulant medication treatment should immediately be seen by a doctor.

FDA is continuing its review of the strengths and limitations of this and other epidemiological studies that evaluate the risks of stimulant medications used to treat ADHD in children. FDA and the Agency for Healthcare Research and Quality are sponsoring a large epidemiological study that will provide further information about the potential risks associated with stimulant medication use in children. The data collection for this study will be complete later in 2009.

Products involved include: Focalin, Focalin XR (dexmethylphenidate HCl ); Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostat (dextroamphetamine sulfate); Vyvanse (lisdexamfetamine dimesylate); Desoxyn (methamphetamine); Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, Ritalin-SR (methylphenidate); Adderall, Adderall XR (mixed salts amphetamine); Cylert (pemoline) and generics.

Levemir Insulin: Check personal supply of insulin to identify possible stolen and dangerous product.
(posted 6/13/2009)

FDA notified patients and healthcare professionals that some stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. are being sold in the U.S. market, may not have been stored and handled properly, and may be dangerous for patients to use. The agency is advising patients who use Levemir insulin to:

1) Check your personal supply of insulin to determine if you have Levemir insulin from one of the following lots: XZF0036, XZF0037, and XZF0038.
2) Do not use your Levemir insulin if it is from one of these lots.
3) Always visually inspect your insulin before using it. Levemir is a clear and colorless solution.
4) Contact the Novo Nordisk Customer Care Center at 1-800-727-6500 for what to do with vials from these lots or if you have any other questions.

Propylthiouracil associated with risk of serious liver injury and death
(posted 6/4/2009)

FDA notified healthcare professionals of the risk of serious liver injury, including liver failure and death, with the use of propylthiouracil in adult and pediatric patients. Reports to FDA’s Adverse Event Reporting System (AERS) suggest there is an increased risk of hepatotoxicity with propylthiouracil when compared to methimazole. FDA has identified 32 (AERS) cases (22 adult and 10 pediatric) of serious liver injury associated with propylthiouracil use. Although both propylthiouracil and methimazole are indicated for the treatment of hyperthyroidism due to Graves’ disease, healthcare professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves’ disease. Physicians should closely monitor patients on propylthiouracil therapy for symptoms and signs of liver injury, especially during the first six months after initiation of therapy. Propylthiouracil should not be used in pediatric patients unless the patient is allergic to or intolerant of methimazole, and there are no other treatment options available.

Digoxin, USP 0.125 mg, Digoxin, USP 0.25 mg (Caraco brand)
(posted 5/12/2009)

AS Medication Solutions, LLC, a drug repackage company, announced today that all tablets of Caraco brand Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of August, 2011, are being voluntarily recalled to the consumer level. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin. Caraco Pharmaceutical Laboratories, Ltd manufactured the recalled tablets. The recalled product is a scored round biconvex white tablet imprinted with “441”, with an NDC number of 54569-5758-0 (30-count). Consumers with the product that are within expiration should return these products to their pharmacy or place of purchase.

Tarceva (erlotinib): warning about GI perforation, exfoliative skin conditions and corneal perforation/ulceration
(posted 5/8/2009)

OSI, Genentech and FDA notified healthcare professionals of new safety information added to the WARNINGS AND PRECAUTIONS sections of the prescribing information for Tarceva. Gastrointestinal perforation (including fatalities), bullous, blistering and exfoliative skin conditions including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, in some cases fatal, and ocular disorders, including corneal perforation or ulceration have been reported during use of Tarceva. The new safety information comes from routine pharmacovigilance activities of clinical study and postmarketing reports. Tarceva monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. In combination with gemcitabine, Tarceva is also indicated for the first-line treatment of patients with locally advanced, unresectable, or metastatic pancreatic cancer.

Testosterone gel products: Boxed warning of risk of unintended secondary exposure of children
(posted 5/7/2009)

FDA notified healthcare professionals that it will require two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, to include a boxed warning on the products’ labels after receiving reports of adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated with these products. Despite the currently labeled precautions, FDA has received reports of eight cases of secondary exposure to testosterone in children ranging in age from nine months to five years. Since that time, additional reports of secondary exposure have been received by the agency and are presently under review. Of the fully reviewed cases, adverse events reported in these children included inappropriate enlargement of the genitalia (penis or clitoris), premature development of pubic hair, advanced bone age, increased libido and aggressive behavior. The gels are approved for use in men who either no longer produce testosterone or produce it in very low amounts. Both products are applied once daily, to the shoulders or upper arms. FDA has provided recommendations and precautions to minimize the potential for secondary exposure.

Hydroxycut Products
(posted 5/1/2009)

FDA warned consumers to immediately stop using Hydroxycut products by Iovate Health Sciences, Inc. Hydroxycut products are associated with a number of serious liver injuries. Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names.

FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects.

Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B)
(posted 4/30/2009)

FDA notified healthcare professionals that after an ongoing safety review initiated in February 2008, the manufacturers of licensed botulinum toxin products will be required by FDA to strengthen warnings in product labeling and add a boxed warning regarding the risk of adverse events when the effects of the toxin spread beyond the site where it was injected.

FDA will also require that manufacturers develop and implement a Risk Evaluation and Mitigation Strategy [REMS], including a communication plan to provide more information regarding the risk for distant spread of botulinum toxin effects after local injection, as well as information to explain that botulinum toxin products cannot be interchanged. The REMS would also include a Medication Guide that explains the risks to patients, their families, and caregivers. FDA is requiring the manufacturers to submit safety data after multiple administrations of the product in a specified number of children and adults with spasticity to assess the signal of serious risk regarding distant spread of toxin effects.

Libimax - Recall of dietary supplement due to undeclared drug tadalafil
(posted 4/29/2009)

Nature & Health Co. and FDA notified healthcare professionals of a recall of a supplement product, Libimax. FDA analysis found the product contains tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction. This product poses a threat to health because tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Consumers who have Libimax in their possession should stop using it immediately and contact their physician if they experienced any problem that may be related to taking this product.

Dietary Supplements [Universal ABC Beauty Supply] - Recall
(posted 4/22/2009)

ABC Beauty Supply and FDA notified consumers and healthcare professionals of a recall of 34 dietary supplement products. FDA lab analyses identified undeclared sibutramine, an FDA-approved drug, used as an appetite suppressant for weight loss. FDA advises that these products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. See the firm's press release for a list of affected products.

Influend Cough and Cold Products: Recall due to possibility of product being superpotent
(posted 4/16/2009)

ION Labs and FDA notified consumers and healthcare professionals of the recall of all Influend Cough and Cold products sold on or after May 30, 2008 due to the possibility that the products may be superpotent with possible complications ranging from tachycardia, palpitations, arrhythmias, and cardiovascular collapse with hypotension to headaches, dizziness, anxiety, restlessness and nervousness. Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.

Ceftriaxone: Update on interaction with calcium-containing products
(posted 4/14/2009)

FDA notified healthcare professionals of an update to a previous alert that addresses the interaction of ceftriaxone with calcium-containing products, based on previously reported fatal cases in neonates. At the request of FDA, the manufacturer of ceftriaxone (Roche) conducted two in vitro studies to assess the potential for precipitation of ceftriaxone-calcium when ceftriaxone and calcium-containing products are mixed in vials and in infusion lines. These two in vitro studies were conducted in neonatal and adult plasma to assess the potential for precipitation of ceftriaxone-calcium using varying ceftriaxone and calcium concentrations, including concentrations in excess of those achieved in vivo. Based on the results from these studies, FDA now recommends that ceftriaxone and calcium-containing products may be used concomitantly in patients greater than 28 days of age, using the precautionary recommendations noted because the risk of precipitation is low in this population. FDA had previously recommended, but no longer recommends, that in all age groups ceftriaxone and calcium-containing products should not be administered within 48 hours of one another.

Raptiva (efalizumab) - Withdrawn from market
(posted 4/8/2009)

Genentech and FDA notified healthcare professionals of the voluntary, phased withdrawal of Raptiva, a medication for treatment of psoriasis, from the U.S. market due to a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML). By June 8, 2009, Raptiva will no longer be available in the United States. Prescribers are being asked not to initiate Raptiva treatment for any new patients. Prescribers should immediately begin discussing with patients currently using Raptiva how to transition to alternative therapies. The FDA strongly recommends that patients work with their health care professional to transition to alternative therapies for psoriasis.

Digoxin (Caraco brand) - Recall of tablets because they may differ in size
(posted 4/1/2009)

Caraco Pharmaceutical Laboratories and FDA notified healthcare professionals of a consumer-level recall of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin, a drug product used to treat heart failure and abnormal heart rhythms. The drug has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability. Consumers with the recalled product should return these products to their pharmacy or place of purchase.

FDA Acts to Halt Marketing of Certain Unapproved Prescription Narcotic Drugs
(posted 3/31/2009)

The U.S. Food and Drug Administration today warned nine companies to stop manufacturing 14 unapproved narcotic drugs that are marketed in several dosage forms and are widely used to treat pain. The FDA's warning letters notified the companies they may be subject to enforcement action if they do not stop manufacturing and distributing prescription unapproved products that include high concentrate morphine sulfate oral solutions and immediate release tablets containing morphine sulfate, hydromorphone or oxycodone. This action does not include oxycodone capsules.

Watson Announces Voluntary Recall of Propafenone HCL Tablets
(posted 3/25/2009)

FDA and Watson Pharmaceuticals notified healthcare professionals and patients of a recall of Propafenone HCL 225 mg tablets, a drug product used to treat cardiac arrhythmias. The drug is being recalled because some tablets may contain slightly higher levels of the active ingredient than specified. Because it has a narrow therapeutic index, some patients who are particularly sensitive to small variations in dose may experience potentially serious side effects, including arrhythmias (irregular heartbeat) or low blood pressure. The affected lot [lot number 112680A, expiration date July 31, 2010] of Propafenone HCL tablets was shipped to customers between October 15, 2008 and November 26, 2008. The Press Release includes instructions for identifying and returning the affected product.

Myfortic (mycophenolic acid) Medication Guide released
(posted 3/24/2009)

FDA and Novartis notified healthcare professionals of the introduction of a Myfortic Medication Guide to provide important safety information in language that patients can easily comprehend. By May 15, 2009, a copy of the Myfortic Medication Guide will be enclosed with every Myfortic bottle. Pharmacists are required to distribute a copy of the Medication Guide with every Myfortic prescription.

Weight Loss Products - nationwide alert expanded
(posted 3/20/2009)

FDA expanded its nationwide alert to consumers about tainted weight loss products containing undeclared, active pharmaceutical ingredients. The FDA has identified additional weight loss products (Herbal Xenicol, Slimbionic, and Xsvelten) and new undeclared active pharmaceutical ingredients (fenproporex, fluoxetine, furosemide, and cetilistat). The current list now includes 72 products.

Zencore Plus recalled due to product containing undeclared drug
(posted 3/20/2009)

Bodee LLC and FDA notified consumers and healthcare professionals of a nationwide recall of all the company's supplement product sold under the name Zencore Plus. FDA lab analysis of Zencore Plus samples found the product contains benzamidenafil, an undeclared drug product and a PDE5 inhibitor. The use of Zencore Plus by an unsuspecting user of organic nitrates may pose a life-threatening risk of sudden and profound drop of blood pressure due to potential interaction between benzamidenafil and organic nitrates. Zencore Plus is sold in health food stores and by mail order on internet nationwide. Consumers who have this product in their possession should stop using it immediately.

DAYTRANA (methylphenidate transdermal system) patches
(posted 3/20/2009)

Shire plc announced today a voluntary market withdrawal/recall of thirty-nine (39) lots of the ADHD patch DAYTRANA. Shire is taking this action because some DAYTRANA patches no longer meet their release liner removal specification, and as a result, patients and caregivers could have difficulties removing the liners. Physicians, patients, and caregivers who have questions about DAYTRANA should call Shire’s DAYTRANA customer service line at 1-800-828-2088, option 1, and pharmacists should call 1-888-202-3822.

Insulin Pens: Risk of Transmission of Blood-borne Pathogens from Shared Use
(posted 3/19/2009)

The FDA notified healthcare providers and patients that insulin pens and insulin cartridges are never to be shared among patients. Sharing of insulin pens may result in transmission of hepatitis viruses, HIV, or other blood-borne pathogens. Insulin pens are not designed, and are not safe, for one pen to be used for more than one patient, even if needles are changed between patients because any blood contamination of the pen reservoir could result in transmission of already existing blood-borne pathogens from the previous user. The FDA is working with the Centers for Disease Control and Prevention, professional societies and healthcare organizations to reinforce patient and healthcare provider education about proper and safe use of insulin pens.

Transdermal Drug Patches with Metallic Backings
(posted 3/5/2009)

FDA notified healthcare professionals and patients that certain transdermal patches (medicated patches applied to the skin), containing aluminum or other metals in the backing of the patches, can overheat during an MRI scan and cause skin burns in the immediate area of the patch. FDA is in the process of reviewing the labeling and composition of all medicated patches to ensure that those made with materials containing metal provide a warning about the risk of burns to patients who wear the patches during an MRI scan. Until this review is complete, FDA recommends that healthcare professionals referring patients to have an MRI scan identify those patients who are wearing a patch before the patients have the MRI scan. The healthcare professional should advise these patients about the procedures for removing and disposing of the patch before the MRI scan, and replacing the patch after the MRI scan. MRI facilities should follow published safe practice recommendations concerning patients who are wearing patches.

Metoclopramide-containing drugs: chronic use linked to tardive dyskinesia
(posted 2/26/2009)

FDA notified healthcare professionals that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken. These symptoms are rarely reversible and there is no known treatment. Metoclopramide is available in a variety of formulations including tablets, syrups and injections. Names of metoclopramide-containing products include Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection. Manufacturers will be required to implement a risk evaluation and mitigation strategy [REMS] to ensure patients are provided with a medication guide that discusses this risk. Current product labeling warns of the risk of tardive dyskinesia with chronic metoclopramide treatment.

CellCept (mycophenolate mofetil) Medication Guide
(posted 2/12/2009)

FDA and Roche Laboratories notified healthcare professionals of the introduction of a CellCept Medication Guide to provide important safety information in language that patients can easily comprehend. FDA regulations require a pharmacist to distribute a copy of the Medication Guide to every patient who fills a CellCept prescription from this point forward. FDA has also required the introduction of a Medication Guide for mycophenolic acid, marketed as Myfortic by Novartis.

Ethex recalls prescription prenatal vitamin and iron supplement products
(posted 2/4/2009)

ETHEX Corporation expanded the company's previous recall notices to include prescription prenatal vitamin and iron supplement products. See the 02/03/2009 Press Release (www.fda.gov/oc/po/firmrecalls/ethex02_09.html) for a list of products included in the recall.

Ethex Corporation Product Recall
(posted 1/27/2009)

FDA notified pharmacists and consumers that ETHEX Corporation has expanded two previous 2008 recalls to include over 60 generic drug products recalled to wholesalers, and two generic drug products, Hydromorphone HCl and Metoprolol Succinate, recalled to retailer level. These generic products may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices. Some of these products have had specific lots recalled earlier due to defects found, including oversized tablets delivering higher than labeled doses. These additional products are being removed to assure that no other defective products remain in the marketplace. Patients who may have these medicines in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medication may place patients at risk. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products, or to obtain replacement medications or prescriptions.

Ther-Rx Corporation Nationwide Voluntary Recall of Products
(posted 1/26/2009)

Ther-Rx Corporation, a subsidiary of KV Pharmaceutical, is issuing, as previously disclosed by KV Pharmaceutical Company on January 26, 2009, a voluntary nationwide recall of the products identified below (all lots within expiration) as a precautionary measure because they may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices (cGMPs).

Topical Anesthetics: reminder of potentially serious hazards of using skin numbing products
(posted 1/16/2009)

FDA issued a public health advisory to remind patients, healthcare professionals, and caregivers about potentially serious hazards of using skin numbing products, also known as topical anesthetics, for relieving pain from mammography and other medical tests and conditions. FDA is concerned about the potential for these products to cause serious, life-threatening adverse effects, such as irregular heartbeat, seizures, breathing difficulties, coma and even death, when applied to a large area of skin or when the area of application is covered. FDA is working with healthcare professional organizations and other media that distribute healthcare information to spread the message about the potential hazards and safe use of topical anesthetics. The Advisory and the Dear Colleague letter provide recommendations to both doctors and patients on safe use of these products.

The Drug Safety Newsletter, Volume 2, Issue 1, 2009 is now available
(posted 1/16/2009)

The Drug Safety Newsletter (DSN), Volume 2, Issue 1, 2009 is now available. DSN is published online quarterly, and provides information for healthcare professionals about the findings of selected post-marketing drug safety reviews, important emerging drug safety issues, and recently approved new drugs. The newsletter is intended to complement other FDA methods of communicating drug safety information to the public. FDA also hopes the newsletter will raise awareness of reported adverse events, and stimulate additional adverse event reporting by healthcare professionals.

HYDROmorphone HCl 2 mg Tablets (ETHEX Corp. and KV Pharmaceutical)
(posted 12/24/2008)

ETHEX and FDA notified heathcare professionals of a nationwide recall of a single lot of HYDROmorphone HCl 2 mg Tablets due to potential for oversized tablets. HYDROmorphone is a drug used for pain management. If someone were to take a higher than expected dose of HYDROmorphone, the risk of adverse effects known to be associated with the drug may be increased, including respiratory depression (difficulty or lack of breathing), low blood pressure, and sedation. The recalled tablets are a blue, round tablet with a script "E" on one side and a "2" on the other side.

The parent company of ETHEX Corporation, KV Pharmaceutical has advised FDA that it is voluntarily suspending shipments of all FDA-approved drug products in tablet form. This action is being taken as a precautionary measure, to allow KV to address manufacturing issues that have come to management’s attention. See the full MedWatch 2008 Safety summary for links to the Ethex and KV press releases and a list of KV products affected by the suspension.

Weight Loss Pills contain undeclared, active pharmaceutical ingredients
(posted 12/22/2008)

FDA alerted consumers nationwide not to purchase or consume more than 25 different products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients that may put consumers' health at risk. The undeclared active pharmaceutical ingredients in some of these products include sibutramine (a controlled substance), rimonabant ( a drug not approved for marketing in the United States), phenytoin ( an anti-seizure medication), and phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent). The weight loss products, some of which are marked as "dietary supplements," are promoted and sold on various web sites and in some retail stores.

FDA advises consumers who use the products to stop taking them and consult their healthcare professional immediately as the health risks posed by these products can be serious (for example, high blood pressure, seizures, tachycardia, palpitations, heart attack or stroke). FDA also encourages consumers to seek guidance from healthcare professional before purchasing weight loss products. See the FDA News Release for a listing of the names of the 25 referenced products.

Oral Sodium Phosphate (OSP) Products for Bowel Cleansing (marketed as Visicol and OsmoPrep, and oral sodium phosphate products available without a prescription)
(posted 12/11/2008)

FDA has become aware of reports of acute phosphate nephropathy, a type of acute kidney injury, associated with the use of oral sodium phosphate products (OSP) for bowel cleansing prior to colonoscopy or other procedures. These products include the prescription products, Visicol and OsmoPrep, and OSPs available over-the-counter without a prescription as laxatives (e.g., Fleet Phospho-soda). In some cases when used for bowel cleansing, these serious adverse events have occurred in patients without identifiable factors that would put them at risk for developing acute kidney injury.

FDA is requiring the manufacturer of Visicol and OsmoPrep, the two OSPs available by prescription only, to add a Boxed Warning to the labeling for these products. FDA is also requiring that the manufacturer develop and implement a risk evaluation and mitigation strategy (REMS), which will include a Medication Guide, to ensure that the benefits of these products outweigh the risk of acute phosphate nephropathy, and to conduct a postmarketing clinical trial to further assess the risk of acute kidney injury with use of these products. FDA recommends, in light of the risk of acute phosphate nephropathy, over-the-counter laxative OSP products should not be used for bowel cleansing. Consumers should only use OSPs for bowel cleansing pursuant to a prescription from a healthcare professional.

Hospira's 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP
(posted 12/8/2008)

Hospira, Inc. notified healthcare professionals of a recall of one lot (lot number 65-620-FW, expiration date May 1, 2010, NDC 0409-7902-09) of 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP in 1000 mL flexible plastic containers. A small number of the containers may be incorrectly labeled with a bar code for 5% Dextrose Injection, USP (NDC 0409-7922-09). The incorrect bar code could lead to a medication error resulting in the wrong drug being delivered to a patient if a bar code system is used to confirm the medication. Potential adverse events related to an error of this type include electrolyte imbalance, cardiac dysfunction, gastrointestinal disturbances, paresthesia and mental confusion. The affected lot was shipped to U.S. customers between July 2008 and September 2008. Healthcare facilities with an existing inventory should quarantine the product immediately and call Hospira Customer Care at 1-877-946-7747 for instructions on how to return it.

Phenytoin and Fosphenytoin Sodium associated with potential increased risk of serious skin reactions
(posted 11/24/2008)

FDA is investigating new preliminary data regarding a potential increased risk of serious skin reactions including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) from phenytoin therapy in Asian patients positive for human leukocyte antigen (HLA) allele, HLA-B*1502. This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including Han Chinese, Filipinos, Malaysians, South Asian Indians, and Thais. Until the FDA evaluation is completed, healthcare providers who are considering the use of phenytoin or fosphenytoin should be aware of the risks and benefits described in the current prescribing information for this drug. Healthcare providers should consider avoiding phenytoin and fosphenytoin as alternatives for carbamazepine in patients who test positive for HLA-B*1502. A summary of the data currently being analyzed by FDA, and information for patients and healthcare professionals to consider, can be found in the links provided in the MedWatch safety alert.

Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas)
(posted 11/12/2008)

Johnson & Johnson - Merck Consumer Pharmaceuticals Company and FDA notified consumers and healthcare professionals of a voluntary recall of Infants' Mylicon Gas Relief Dye Free Drops (Lot No. SMF007 and SMF008) sold in 1 oz plastic bottles that were distributed after October 5, 2008, nationwide. The product was recalled because some bottles could include metal fragments that were generated during the manufacturing process. Parents who have given the product to their infant and are concerned should contact their healthcare professional.

ETHEX Corporation - Nationwide Voluntary Recall of Five Generic Products
(posted 11/10/2008)

Ethex Corp and FDA notified healthcare professionals of a voluntary recall of five generic products (Propafenone HCl Tablets, Isosorbide Mononitrate Extended Release Tablets, Morphine Sulfate Extended Release Tablets, Morphine Sulfate Immediate Release Tablets, and Dextroamphetamine Sulfate Tablets). The products were recalled because they may contain oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient that could result in patients receiving as much as twice the expected dosage of these drugs, which could cause serious or life-threatening consequences.

Overdoses can include arrhythmias and low blood pressure with Propafenone HCl; fainting and low blood pressure with Isosorbide Mononitrate; respiratory depression and low blood pressure with Morphine Sulfate; and rapid heart rate and high blood pressure with Dextroamphetamine Sulfate. Patients who experience any adverse reactions to these drugs should contact their healthcare professional immediately. See the manufacturer's recall notice for specific lot numbers of the products affected by this recall.

Dextroamphetamine Sulfate 5mg Tablets (Ethex)
(posted 10/16/2008)

Ethex Corp and FDA notified healthcare professionals of a voluntary recall of three lots of Dextroamphetamine Sulfate 5mg tablets. The product was recalled due to the potential presence of oversized tablets that may contain as much as twice the labeled amount of the active ingredient. Taking a higher than expected dose of Dextroamphetamine Sulfate may be associated with an increased risk of adverse effects such as tachycardia, hypertension, tremors, decreased appetite, headache, insomnia, dizziness, blurred vision, stomach upset, and drug mouth. Consumers and their caregivers should not use any Dextroamphetamine Sulfate tablets that appear to be oversized and should consult their healthcare professional with any questions.

Over The Counter Cough and Cold Medications
(posted 10/9/2008)

FDA notified healthcare professionals and consumers that the Consumer Healthcare Products Association (CHPA) is voluntarily modifying the product labels for consumers of over the counter (OTC) cough and cold medicines to state "do not use" in children under 4 years of age. FDA supports CHPA members to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children. FDA continues to assess the safety and efficacy of these products and to revise its OTC list of approved ingredients and amounts for these medicines. Parents and care givers should adhere to the dosage instructions and warnings on the label that accompanies OTC cough and cold medications before giving the product to children, and should consult their healthcare professionals if they have any questions or concerns.

Epoetin alfa - Early Communication about an Ongoing Safety Review
(posted 9/23/2008)

FDA has been made aware of preliminary safety findings from a clinical trial conducted in Germany investigating the use of epoetin alfa to treat acute ischemic stroke. The clinical trial utilized doses of epoetin alfa that were considerably higher than the doses recommended for the treatment of anemia as described in the FDA-approved labeling for the product. Over a period of ninety days after the start of the trial, there were more deaths in the group of patients who received epoetin alfa compared to patients who received the placebo (16% versus 9%). Roughly half of all deaths in both groups occurred within the first seven days after starting the drug, with death from intracranial hemorrhage (bleeding within the brain) occurring among approximately 4% of patients who received epoetin alfa compared to 1% of patients in the placebo group.

FDA anticipates the receipt of additional data within the next several weeks. As soon as the review of these data is complete, FDA will communicate our conclusions and recommendations to the public. The finding of increased mortality in patients receiving epoetin alfa in the German trial suggests the need to closely monitor patients enrolled in other ongoing trials for adverse outcomes and to evaluate whether the potential benefits for enrolled patients outweigh the risks in these trials.

Tarceva (erlotinib)
(posted 9/23/2008)

OSI and Genentech notified healthcare professionals that cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva, particularly in patients with baseline hepatic impairment. Patients with hepatic impairment receiving Tarceva should be closely monitored during therapy and the product should be used with extra caution in patients with total bilirubin >3x ULN. Dosing should be interrupted or discontinued if changes in liver function are severe, such as doubling of total bilirubin and/or tripling of transaminases in the setting of pretreatment values outside the normal range. New information from a pharmacokinetic study in patients with moderate hepatic impairment associated with significant liver tumor burden has been provided in the revised prescribing information, and other recommendations are included in the WARNINGS and DOSAGE AND ADMINISTRATION sections.

Vivitrol (naltrexone)
(posted 8/12/2008)

FDA informed healthcare professionals of the risk of adverse injection site reactions in patients receiving naltrexone. Naltrexone is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment. Naltrexone is administered as an intramuscular gluteal injection and should not be administered intravenously, subcutaneously, or inadvertently into fatty tissue. Physicians should instruct patients to monitor the injection site and contact them if they develop pain, swelling, tenderness, induration, bruising, pruritus, or redness at the injection site that does not improve or worsens within two weeks. Physicians should promptly refer patients with worsening injection site reactions to a surgeon. Read the FDA recommendations for healthcare professionals to consider regarding the use of Naltrexone injection.

Simvastatin Used With Amiodarone
(posted 8/8/2008)

FDA notified healthcare professionals of the risk of muscle injury, rhabdomyolysis, which can lead to kidney failure or death, when simvastatin is used with amiodarone. This risk is dose-related and increases when a dose of simvastatin greater than 20 mg per day is given with amiodarone. Although a revision of the simvastatin labeling in 2002 described an increased risk of rhabdomyolysis when amiodarone is taken with simvastatin doses greater than 20 mg daily, FDA continues to receive reports of rhabdomyolysis in patients treated concurrently with amiodarone and simvastatin. Prescribers should be aware of the increased risk of rhabdomyolysis when simvastatin is prescribed with amiodarone, and they should avoid doses of simvastatin greater than 20 mg per day in patients taking amiodarone.

Fluoroquinolone Antimicrobial Drugs
(posted 7/8/2008)

FDA notified healthcare professionals that a BOXED WARNING and Medication Guide are to be added to the prescribing information to strengthen existing warnings about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones for systemic use.

Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture. This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy. Physicians should advise patients, at the first sign of tendon pain, swelling, or inflammation, to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non-fluoroquinolone antimicrobial drug. Selection of a fluoroquinolone for the treatment or prevention of an infection should be limited to those conditions that are proven or strongly suspected to be caused by bacteria.

Solodyn (minocycline HCL) Extended Release Tablets 90 mg
(posted 5/19/2008)

Medicis and FDA notified healthcare professionals of the recall of lot numbers B080037 (Exp: 12/09) and B080038 (Exp: 12/09) of Solodyn Extended Release Tablets. The product was recalled because one of the bottles contained Azasan (azathioprine tablets) 75mg instead of Solodyn 90mg Tablets. Azasan is an immunosuppressive agent used in transplant patients to prevent kidney rejection and for the treatment of rheumatoid arthritis. Taking Azasan instead of Solodyn presents a health hazard and safety risk to patients. Side effects associated with the use of Azasan, particularly in the elderly, include myelosuppression, infection, bleeding, chills, nausea, vomiting and diarrhea. Joint and muscle pain are also common side effects. Additionally, unanticipated interactions with other drugs may also lead to serious adverse events. The recall is limited to the lots referenced above. Healthcare professionals are urged to check their inventory and pull the referenced lot numbers from their stock and make arrangements with the manufacturer to return the product.

Use Caution with Over-the-Counter Creams, Ointments
(posted 4/1/2008)

Acne, cough due to a cold, athlete's foot, hemorrhoids, itching from insect bites, and minor aches and pains of muscles and joints—these are among the conditions that people treat by applying over-the-counter (OTC) creams and ointments to their skin. The Food and Drug Administration (FDA) urges consumers to keep safety in mind when using such treatments.

FDA 101: Medication Errors
(posted 3/17/2008)

FDA has published a consumer-oriented article on efforts to reduce medication errors. The article discusses collaborative efforts undertaken by FDA, USP, and ISMP.

Tussionex: Reports of life-threatening events and deaths
(posted 3/11/2008)

FDA informed healthcare professionals of life-threatening adverse events and death in patients, including children, who have received Tussionex Pennkinetic Extended-Release Suspension (Tussionex). The reports indicate that healthcare professionals have prescribed Tussionex for patients younger than the approved age group of 6 years old and older, and more frequently than the labeled dosing interval of every 12 hours. Tussionex is contraindicated for use in patients less than 6 years of age because of their susceptibility to life-threatening and fatal respiratory depression.

Patients have administered the incorrect dose due to misinterpretation of the dosing directions, and have used inappropriate devices to measure the suspension. Overdose of Tussionex in older children, adolescents, and adults has also been associated with life-threatening and fatal respiratory depression. Prescribers should be familiar with the dosing recommendations of Tussionex before prescribing. In addition, patients and caregivers should use a properly marked measuring device to measure Tussionex to prevent overdose.

Spiriva & Foradil Capsules For Inhalation - Correct Use Of The Products
(posted 2/29/2008)

FDA informed healthcare professionals and consumers of the correct way to use Spiriva and Foradil inhalation powder capsules. FDA and the American Association of Poison Control Center’s (AAPCC) National Poison Data System have received many reports of patients swallowing Spiriva and Foradil capsules rather than placing the capsules in the inhalation devices. Both products are to be used in the HandiHaler (Spiriva) and Aerolizer (Foradil) devices to deliver the medicine to the lungs to improve breathing in patients with asthma, and in individuals affected by chronic obstructive lung disease and bronchitis. Both products will not treat a patient's breathing condition if the contents of a capsule are swallowed rather than inhaled. Healthcare professionals should discuss with patients how to correctly use the Spiriva HandiHaler or Foradil Aerolizer. See the Public Health Advisory for important information on the correct use of both products.

Cough and Cold Medications in Children Less Than Two Years of Age
(posted 1/17/2008)

FDA informed consumers and healthcare professionals that the Agency has completed its review of information regarding the safety of over-the-counter (OTC) cough and cold medicines in children under 2 years of age and recommends that these drugs not be used to treat children in this age group because serious and potentially life-threatening side effects can occur. FDA's recommendation is based on both the review of the information the Agency received about serious side effects in children in the referenced age group and the discussion and recommendations made at the October 18 -19, 2007, public advisory committee meeting at which this issue was discussed. FDA has not completed its review of information about the safety of OTC cough and cold medicines in children 2 through 11 years of age.

Edetate Disodium (marketed as Endrate and generic products)
(posted 1/16/2008)

FDA notified healthcare professionals and patients about important safety information concerning Edetate Disodium. There have been cases where children and adults have died when they were mistakenly given Edetate Disodium instead of Edetate Calcium Disodium (Calcium Disodium Versenate) or when Edetate Disodium was used for "chelation therapies" and other uses that are not approved by the FDA. Edetate Disodium was approved as an emergency treatment for certain patients with hypercalcemia (very high levels of calcium in the blood) or certain patients with heart rhythm problems as a result of very high amounts of digitalis in the blood. Edetate Calcium Disodium was approved to reduce dangerously high blood lead levels (severe lead poisoning).

The two drugs have very similar names and are commonly referred to only as EDTA. As a result, the two products are easily mistaken for each other when prescribing, dispensing, and administering them. Edetate Disodium and Edetate Calcium Disodium works by binding with heavy metals or minerals in the body allowing them to be passed out of the body through the urine.

Fentanyl Transdermal System - Updated Information On Appropriate Prescribing, Dose Selection, and Safe Use
(posted 12/21/2007)

FDA issued an update that highlights important information on appropriate prescribing, dose selection, and the safe use of the fentanyl transdermal system (patch). FDA previously issued a Public Health Advisory and Information for Healthcare Professionals in July 2005 regarding the appropriate and safe use of the transdermal system. However, the Agency continues to receive reports of death and life-threatening adverse events related to fentanyl overdose that have occurred when the fentanyl patch was used to treat pain in opioid-naive patients and when opioid-tolerant patients have applied more patches than prescribed, changed the patch too frequently, and exposed the patch to a heat source. The fentanyl patch is only indicated for use in patients with persistent, moderate to severe chronic pain who have been taking a regular, daily, around-the-clock narcotic pain medicine for longer than a week and are considered to be opioid-tolerant.

Patients must avoid exposing the patch to excessive heat as this promotes the release of fentanyl from the patch and increases the absorption of fentanyl through the skin which can result in fatal overdose. Directions for prescribing and using the fentanyl patch must be followed exactly to prevent death or other serious side effects from fentanyl overdose.
ISMP has written about this serious issue in past newsletters, which can be found at "Ongoing, preventable fatal events with fentanyl transdermal patches are alarming!"

FDA Public Health Advisory for Fentora
(posted 9/26/2007)

FDA issued a Public Health Advisory and a Healthcare Professional Sheet to alert healthcare professionals and consumers regarding concerns over the use of Fentora (fentanyl buccal) tablets after recent reports of deaths and other adverse events. The deaths reported were the result of improper selection of patients, dosing, or improper product substitution.

FDA further stated that it is dangerous to use Fentora for any short-term pain such as headaches or migraines. It is critical that Fentora not be used in patients who are not opioid tolerant.

Patients also must be under a doctor’s care and close supervision while taking Fentora and the dose should be carefully adjusted to control breakthrough pain adequately.

In addition, FDA is concerned about the improper substitution of Fentora, a quick acting pain drug, for other pain medicines. Fentora is not the same as other fentanyl products and cannot be substituted for Actiq, another fentanyl product used to treat breakthrough cancer pain. Because Fentora delivers more fentanyl to the blood than Actiq, substituting Fentora for Actiq using the same dose can result in a fatal overdose.

Fentora (fentanyl buccal tablet) and the occurrence of serious adverse events
(posted 9/13/2007)

Cephalon issued two Dear Healthcare Professional Letters to inform prescribers and other healthcare providers of important safety information regarding Fentora. Fentora is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Serious adverse events, including deaths, have occurred in patients treated with Fentora. These deaths occurred as a result of improper patient selection (e.g., use in opioid non-tolerant patients), improper dosing, and/or improper product substitution.

Topical Anesthetic Drugs for Cosmetic Procedures
(posted 2/6/2007)

FDA is issuing this advisory to alert consumers to the potential hazards of using skin numbing products, also known as topical anesthetics, for cosmetic procedures. These topical anesthetics contain anesthetic drugs such as lidocaine, tetracaine, benzocaine, and prilocaine in a cream, ointment, or gel. Topical anesthetics are widely used to numb the skin for medical and cosmetic procedures, and to relieve pain and burning and itching due to a variety of medical conditions. Applying topical anesthetics for a medical procedure is usually done in a doctor’s office by a trained medical professional. However, FDA is aware that use of these products before a cosmetic procedure may not be supervised by trained health professionals. Without this supervision, a patient may apply large amounts of topical anesthetics to their skin. This application can result in high levels of these products in the blood causing life-threatening side effects, such as an irregular heartbeat, seizures, and death.

Compounded topical anesthetic creams can cause serious reactions including seizures, irregular heartbeats and death
(posted 12/6/2006)

FDA notified healthcare professionals and consumers about the serious public health risks related to compounded topical anesthetic creams. FDA issued warning letters to five firms to stop compounding and distributing standardized versions of topical anesthetic creams, marketed for general distribution. Exposure to high concentrations of local anesthetics, like those in compounded topical anesthetic creams, can cause grave reactions including seizures, irregular heartbeats and death. Compounded topical anesthetic creams are often used to lessen pain in procedures such as laser hair removal, tattoos, and skin treatments. They may be dispensed by clinics and spas that provide these procedures, or by pharmacies and doctors' offices.

ISMP has written on this topic on many occasions including our May 2005 issue of the ISMP Medication Safety Alert!, Community/Ambulatory Edition.

Advisory for Users of Diastat AcuDial Delivery Systems
(posted 4/3/2006)

The Food and Drug Administration is advising patients with epilepsy and their care givers of a potential hazard caused by cracks in the applicator tips of Diastat AcuDial (diazepam rectal gel) delivery systems. These cracks can result in the leakage of gel during its application, which results in the patient not getting enough of the medicine to control seizures. Caregivers for these patients are advised to call their local emergency response center or 911 for help in any seizure emergency.

Diastat AcuDial pre-filled syringes are designed to deliver diazepam gel rectally in patients with acute repetitive seizures, a condition that, if inadequately treated, can progress to a life-threatening condition in which seizures are continuous. The drug is typically administered by family members or caregivers at home.

Adverse events with benzocaine sprays
(posted 2/13/2006)

The FDA issued a Public Health Advisory to notify healthcare professionals and patients about adverse events, including methemoglobinemia, associated with the use of benzocaine sprays used in the mouth and throat. Benzocaine sprays are used in medical practice for locally numbing mucous membranes of the mouth and throat for minor surgical procedures or when a tube must be inserted into the stomach or airways. On February 8, 2006, the Veterans Health Administration (VA) announced the decision to stop using benzocaine sprays for these purposes. The FDA is aware of the reported adverse events and is reviewing all available safety data, but at this time is not planning action to remove the drugs from the market. ISMP has written on this topic on many occasions including our Oct. 3, 2002 ISMP Medication Safety Alert!, an article in the Archives of Internal Medicine (Reported Adverse Event Cases of Methemoglobinemia Associated With Benzocaine Products Thomas J. Moore; Christopher S. Walsh, PharmD; Michael R. Cohen, RPh, MS, DSc Arch Intern Med. 2004;164:1192-1196) as well as a recent press release.

Alert for Healthcare Professionals Nimodipine (marketed as Nimotop)
(posted 1/20/2006)

The FDA has requested that Bayer add a boxed warning to the nimodipine (Nimotop) labeling to warn about medication administration errors with nimodipine. Nimodipine is approved for oral administration to improve neurological outcome after subarachnoid hemorrhage. When administered intravenously or parenterally, it can cause serious adverse events, including death. Nimodipine must not be administered intravenously or by any parenteral route. ISMP wrote about the dangers of nimodipine accidentally given intravenously in the August 25, 1999 Medication Safety Alert ! as well as the July 25, 2005 edition.

Consumers Filling U.S. Prescriptions Abroad May Get the Wrong Active Ingredient Because of Confusing Drug Names
(posted 1/11/2006)

The Food and Drug Administration (FDA) released a public health advisory cautioning consumers about filling prescriptions abroad, due to the possible confusion of drugs with the same name but different active ingredients, an issue that ISMP has brought to light in the past. The advisory contains FDA-generated lists of identical and very similar brand names used for different drugs marketed in the U.S. and overseas. The impetus for the FDA’s investigation was ISMP’s January 27, 2005 newsletter article as well as subsequent Wall Street Journal coverage, which are both mentioned in the text. The FDA also notes that the advisory complements ISMP’s findings.

Press release: http://www.fda.gov/bbs/topics/news/2006/NEW01295.html
Public Health Advisory: http://www.fda.gov/oc/opacom/reports/confusingnames.html

Avinza (morphine sulfate extended-release capsules)
(posted 11/3/2005)

Ligand Pharmaceuticals Inc. and FDA notified healthcare professionals of revisions to sections of the prescribing information to highlight and strengthen the warning that patients should not consume alcohol while taking Avinza. Additionally, patients must not use prescription or non-prescription medications containing alcohol while on Avinza therapy. Consumption of alcohol while taking AVINZA may result in the rapid release and absorption of a potentially fatal dose of morphine.

Abbott Diabetes Care Blood Glucose Meters
(posted 10/27/2005)

FDA notified health care providers and patients of a problem with blood glucose meters made by Abbott Diabetes Care, Alameda, Calif. The meters can unintentionally be switched from one unit of measurement to another, resulting in an inaccurate blood glucose interpretation by the user. Users in the United States should make sure that their meter reading is displayed as mg/dL because an inaccurate reading can lead to taking the wrong dose of insulin or dietary changes, resulting in higher levels of sugar in the blood or hyperglycemia.

Toprol-XL (metoprolol succinate) extended release tablets
(posted 9/26/2005)

AstraZeneca and FDA notified healthcare professionals reports of medication dispensing or prescribing errors between Toprol-XL (metoprolol succinate) extended release tablets, and Topamax (topiramate), a product of Ortho-McNeil Neurologics, Inc. There have also been reports of medication errors involving confusion between Toprol-XL and Tegretol or Tegretol-XR (carbamazepine), products of Novartis Pharmaceuticals Corporation. These reports include instances where Toprol-XL was incorrectly administered to patients instead of Topamax, Tegretol, or Tegretol-XR, and vice versa, some of them leading to adverse events.

Injectable Products made by Central Admixture Pharmacy Service (CAPS) of Lanham, Maryland
(posted 9/17/2005)

FDA is notifying healthcare professionals and hospitals about a product recall involving all injectable products manufactured by Central Admixture Pharmacy Services, Inc. of Lanham, Maryland (CAPS) due to concerns regarding the sterility of these injectable products. CAPS distributed the affected injectable products to hospitals in Maryland, Delaware, Washington, D.C., and Virginia. Gram negative rods have been identified in two lots of Cardioplegia solution manufactured by CAPS.

NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection) NovoLog (insulin aspart injection)
(posted 9/16/2005)

Until recently, the labeling for these two products was very similar, with the exception of the product names. To facilitate the dispensing of the correct product, Novo Nordisk, Inc. has introduced color branded labeling for NovoLog Mix 70/30, a premixed insulin analog, and NovoLog, a rapid-acting insulin analog. The previous box for NovoLog Mix 70/30 was white with a blue band. The packaging for NovoLog previously was also white with a blue band. The current packaging is now white with an orange band.

Isotretinoin - Accutane and generic isotretinoin
(posted 8/15/2005)

FDA notified healthcare professionals and patients of the approval of a strengthened risk management program, called iPLEDGE, for Accutane and generic isotretinoin. The strengthened program requires registration of wholesalers, prescribers, pharmacies and patients who agree to accept specific responsibilities designed to minimize pregnancy exposures in order to distribute, prescribe, dispense and use Accutane.

Perrigo Infants’ Oral Drops Containing Enclosed Syringe
(posted 8/2/2005)

Perrigo and FDA notified healthcare professionals and consumers of the recall of all lots of concentrated infants’ drops that are packaged with a dosing syringe bearing only a “1.6 mL” mark containing:

1. acetaminophen,


2. acetaminophen, dextromethorphan HBr, and pseudoephedrine HCl, or


3. dextromethorphan HBr, and pseudoephedrine HCl.

The dosing syringe may be confusing in determining the proper dose for infants under 2 years of age as directed by a doctor and could lead to improper dosing, including overdosing.

Fentanyl Transdermal (Skin) Patch
(posted 7/15/2005)

FDA issued a public health advisory to alert health care professionals, patients and their caregivers of reports of death and other serious side effects from overdoses of fentanyl in patients using fentanyl transdermal (skin) patches for pain control. Deaths and overdoses have occurred in patients using both the brand name product Duragesic and the generic product.

Duragesic (fentanyl transdermal system)
(posted 7/8/2005)

Janssen and FDA notified healthcare professionals of changes to the BOXED WARNING/WARNINGS, CONTRAINDICATIONS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Duragesic.

Children's Tylenol Meltaways - 80 mg, Children's Tylenol Softchews - 80 mg, and Jr. Tylenol Meltaways - 160 mg
(posted 6/3/2005)

McNeil Specialty Pharmaceuticals and FDA notified consumers and healthcare professionals about a nationwide recall of all lots and all flavors of Children's TYLENOL Meltaways 80 mg, Children's TYLENOL SoftChews 80mg, and Junior TYLENOL Meltaways 160mg. The recall addresses issues regarding the design of the blister package, information on the package, and bottle cartons for the products that may be confusing and lead to improper dosing, including overdosing.

Medical Devices

Medtronic Intrathecal Catheters and Revision Kits
(posted 9/24/2009)

FDA notified healthcare professionals of the Class 1 recall of Medtronic SC Catheters and Revision Kit Models: 8709SC, 8731SC, 8578, and 8596SC when paired with the Medtronic IsoMed Pump Model 8472, due to a design incompatibility resulting in a physical interference between the SC catheter connector and the IsoMed pump. This may prevent the SC catheter from completely connecting to the IsoMed pump, even though it may appear to be connected and feel secure and may lead to disruptions of therapy and revision surgery, which pose a risk of serious injury or death.

SC catheters are not compatible with IsoMed pumps but are compatible with Medtronic SynchroMed II and SynchroMed EL pumps. To date, Medtronic has received ten reports worldwide related to improper connection of an SC catheter to an IsoMed pump. In all ten reports, medical intervention was required to correct the condition. Medtronic has provided recommendations in their Medical Device Correction Letter (see link in FDA Recall Notice).

Accusure Insulin Syringes: Nationwide recall
(posted 8/21/2009)

Qualitest Pharmaceuticals and FDA notified patients and healthcare professionals of a voluntary nationwide recall of two lots of Accusure Insulin Syringes. The syringes in these lots have been found to have needles which can detach from the syringe. When the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after an injection. Consumers who have any recalled Accusure Insulin Syringes (31 G –Short Needle-either 1/2 cc or 1 cc, lot number 6JCB1 or lot number 7CPT1) should stop using them and contact Qualitest at 1-800-444-4011 for product replacement instructions. The lot number can be found on the white paper backing of each individual syringe. These recalled products were distributed from January 2007 through June 2008 to wholesalers and retail pharmacies nationwide (including Puerto Rico).

Hospira, Inc. Device Recall - Defective AC Power Cords
(posted 8/17/2009)

Hospira and FDA notified healthcare professionals and patients of a nationwide recall of devices that have defective AC power cords in response to customer reports of sparking, charring and fires on the plug of the power cord. Hospira's investigation of these reports determined that the power cord's prongs may crack and fail at or inside the plug. The potential risks from this power cord failure include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires which may also occur in an oxygen-rich environment. Depending on the device and therapy, these failures may lead to potential serious injury or death. For a list of the recalled devices please refer to the firm press release.

Users with affected power cords that have bent or cracked prongs, burnt plastic or excessive wear and tear should discontinue use immediately and contact their Hospira sales representative or Hospira Technical Support Operations at 1-800-241-4002 (available from 6 a.m. to 4 p.m., Pacific time) for instructions on receiving replacement parts or devices.

Alaris System (Cardinal Health)
(posted 8/5/2009)

FDA notified healthcare professionals of the Class 1 recall of various modules of Cardinal Health’s Alaris System, electronic infusion pumps that deliver controlled amounts of medications or other fluids to patients through an intravenous, intra-arterial, epidural, and other routes of administration. The firm initiated the recall after identifying five problems that affected the Alaris System, including failure of the occlusion warning message, syringe volume warning message, electrostatic discharge protection circuitry and fluid ingress tubing. It was determined that the five failures may result in patients experiencing under- or over-infusion which may result in serious injury or death.The device is intended for use with adult and pediatric patients in hospitals including critical care units, emergency rooms, outpatient surgical centers, hospices, and nursing homes.

Carefusion Issues Update Regarding Previously Disclosed June 12, 2009 Recall of the Alaris®
(posted 7/30/2009)

CareFusion Corporation, which is expected to become a public company following its planned spinoff from Cardinal Health, today issued the following update regarding its previously disclosed recall of the Alaris System:

On June 12, 2009, the company sent an urgent Medical Device Recall Notification to customers of its Alaris® System addressing potential risks identified with the Alaris System. The affected devices have one or more failures associated with the Occlusion Warning Message, Syringe Volume Warning Message, Electrostatic Discharge protection circuitry, and Fluid Ingress into the device's pumping mechanism. This recall also updates the labeling for the Inter Unit Interface (IUI) connectors on the Alaris® System. The potential risks may lead to improper infusion therapy, which could cause serious adverse health consequences or death.

Serial numbers of affected devices, as well as CareFusion's short term instructions to customers, and the firm's strategy to fix the affected devices can be found at: www.cardinalhealth.com/alaris/medical-device-recall/.

Following the FDA's 510(k) clearance of the firm's software correction in July 2009, CareFusion is now implementing corrections for units in the field.

In addition, CareFusion today began sending customers using the Alaris Patient Controlled Analgesia (PCA) module an update to the June 12, 2009, Medical Device Recall Notification. The update contains an additional required action to mitigate potential risk before completion of the field corrective action related to the Syringe Volume Warning Message that may appear while using the Alaris PC unit with the Alaris PCA module. The additional step involves removing the patient-controlled dose request handset from the patient prior to reprogramming the infusion pump.

"Implementation of the corrective action plan is an important area of focus for CareFusion and our customers, to ensure our medical devices in the field are operating as safely and effectively as possible," said Dwight Winstead, chief operating officer of CareFusion. "We continue to work closely with the FDA under our new quality system with the goal of manufacturing and supporting products that are among the safest in the industry."

The company recorded an $18 million reserve in its 2009 fiscal third quarter for all actions related to the corrective action plan and continues to believe the amount to be sufficient to fulfill its remediation obligations.

Instructions to customers

Customer inquiries related to this action should be addressed to the CareFusion recall center at 888-562-6018. Additional information about the recall can be found at www.cardinalhealth.com/alaris/medical-device-recall/.

CareFusion will work with customers to minimize disruption while correcting units at their facilities.

In the interim, customers should follow steps outlined in the June 12 Medical Device Recall Notification and the updated Notification for customers using the Alaris PCA module to minimize potential risk before implementation of the software and hardware updates.

CareFusion notified customers by registered letter on June 12, 2009, posted the customer letter on the company's web site and set up a dedicated call center for customer support. The FDA has also been apprised of this action.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA 5600 Fishers Lane, Rockville, MD 20852-9787, or at www.fda.gov/medwatch.

About CareFusion Corporation

CareFusion Corporation, a wholly owned subsidiary of Cardinal Health (NYSE:CAH), is expected to become a public company with the planned spinoff of the clinical and medical products businesses of Cardinal Health. The global company serves the health care industry with products and services that help hospitals measurably improve the safety and quality of healthcare. CareFusion develops market-leading technologies including Alaris® IV pumps, Pyxis® automated dispensing and patient identification systems, AVEA and Pulmonetic Systems™ ventilation and respiratory products, ChloraPrep® for infection prevention and MedMined™ services for infection surveillance, neurological monitoring and diagnostic products, V. Mueller® surgical instruments and an extensive line of products that support interventional medicine.

CareFusion employs more than 15,000 people across its global operations. The company has been authorized to have its shares of common stock listed on the New York Stock Exchange under the ticker symbol "CFN." More information may be found at carefusion.com.

Mallinckrodt Sodium Chromate Cr-51 Injection
(posted 7/10/2009)

Covidien and FDA announced the recall of one lot [#370-9004] of Mallinckrodt Sodium Chromate Cr-51 Injection as a result of routine post-market testing in which the product was found to be subpotent. Sodium Chromate Cr-51 Injection is a radiopharmaceutical agent used in a diagnostic test to determine the presence of a disease known as Polycythemia rubra vera. Using subpotent product could lead to an incorrect test result. A misdiagnosis or delayed diagnosis followed by a delay in treatment puts patients at an increased risk of embolus or stroke. This recall is being conducted to inform healthcare providers of the potential for a false low reading of red blood cell volume and to prevent further use of the product. Customers who have product from the recalled lot in their possession should discontinue use immediately. Customers with questions about the recalled product, including returns, should contact Product Monitoring at 800-778-7898 (7:00 am to 5:00 pm CT).

Disetronic Medical Systems Inc. announces a recall the ACCU-CHEK® Spirit insulin pump
(posted 4/30/2009)

Disetronic Medical Systems Inc. announced today that it is notifying its customers, distributors and healthcare professionals about a potential defect in the “up” and/or “down” buttons of some ACCU-CHEK Spirit insulin pumps. This failure may present as an intermittent or complete loss of function of the “up” and/or “down” buttons. The pump’s “up” and “down” buttons are used for changing the program in the menu or to administer additional insulin through a bolus delivery. If the buttons do not function, users may not be able to change any programmed setting on the pump. If this failure occurs, the pump may not respond with a vibration or acoustic confirmation signal to a button press and the display will remain unchanged. This defect was discovered through the company’s normal quality control monitoring process.

The notifications provide specific actions and details that customers, distributors and healthcare professionals need to take. The pumps in question have serial numbers in the range from SN02119552 through SN10006093 (US market).

Colleague Single and Triple Channel Volumetric Infusion Pumps by Baxter recalled
(posted 3/12/2009)

FDA notified healthcare professionals of a Class 1 Recall of model numbers Mono 2M8151 and 2M8153, CX 2M8161 and 2M8163, and CXE 2M9161and 2M9163. These products were manufactured and distributed from February, 1997 through December, 2008. The company identified software and battery usage failures that result in a delay in or interruption of infusion that may cause serious injury and/or death. Baxter sent a letter to all of its customers, which included advice and instructions to institutions using the infusion pumps.

Nationwide Recall of ReliOn Insulin Syringes for use with U-100 Insulin (Tyco Healthcare - Covidien)
(posted 11/5/2008)

Covidien and FDA notified patients and healthcare professionals of a recall of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles. The mislabeled syringe may result in patients receiving an overdose of as much as 2.5 times the intended dose, with serious health consequences, low blood sugar, and even death. These syringes are sold only by Wal-Mart or Sam's Club pharmacies under the ReliOn name. The recall applies only to lot number 813900. The product was distributed from Aug. 1, 2008 until Oct. 8, 2008, and includes 471,000 individual syringes in 4,710 boxes. FDA urges patients and health care professionals to check syringe packaging carefully for products with this lot number, not to use the product, and return the product to the pharmacy for replacement. The lot number can be found on the back panel of the 100 count syringe carton, or on the white paper backing of each individual syringe “peel-pack”.

Medtronic INDURA 1P Intrathecal Catheter, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit
(posted 10/2/2008)

Medtronic and FDA notified healthcare professionals of the Class I Recall of several Medtronic intrathecal catheters and intrathecal catheter revision kits used with the implanted Medtronic SyncroMed II, SynchroMed EL, and IsoMed infusion pumps that store and deliver parenteral drugs to the intrathecal space. The products were recalled because of potential misconnections of the Medtronic Sutureless Connector Catheters from the catheter port on the pump. These misconnections have resulted in a blockage between the sutureless pump connector and the catheter port on the pump and disconnection from the pump connector. See the FDA Recall Notice for recommendations for healthcare professionals.

Recall Issued For Baxa Corporation Exacta-Mix 2400 Operating Software
(posted 9/27/2007)

Baxa Corporation and FDA informed healthcare professionals of a class I recall of Exacta-Mix 2400 Operating Software Version 1.07, Model No. 8300-0073, Pharmacy Compound System. The device is a compounding system that can be used in pharmacies to add and mix various ingredients into one intravenous (IV) solution.

The device is being recalled because a software failure allowed up to 50mL extra volume of an ingredient to be added to the IV solution that can be life-threatening, particularly in newborns.

Medical Equipment That Uses or Displays Time
(posted 3/2/2007)

FDA notified healthcare professionals and consumers of the possibility that some medical devices/equipment, hospital networks and associated information technology systems may generate adverse events because of the upcoming change in the start and end dates for Daylight Savings Time (DST), and suggested actions to prevent such occurrences. Medical equipment that uses, creates or records time information about a patient's diagnosis or treatment and has not been updated by the manufacturer, may not work properly when the new DST starts three weeks earlier and ends one week later this year.

Additionally, if a medical device or medical device network are adversely affected by the new DST date changes, a patient's treatment or diagnostic result could be:

- incorrectly prescribed
- provided at the wrong time
- missed
- given more than once
- given for longer or shorter durations than intended
- incorrectly recorded

Alaris SE Infusion Pumps recalled due to risk of overinfusion
(posted 8/29/2006)

FDA and Alaris Products notified healthcare professionals of a recall of defective infusion pumps due to a design defect called "key bounce" that may cause potential over-infusion of medications and result in an infusion rate at least 10 times the intended infusion rate. Infusion pumps are electronic devices intended for controlled delivery of intravenous solutions and medications to patients. Key bounce occurs when a number pressed once on the pump registers twice and not detected during programming verification. The products included in this recall (model numbers 7130,7131, 7230, and 7231) are distributed by Cardinal Health Care 303 Inc. The manufacturer provided recommendations to pump users on steps they can take to minimize key entry errors until the problem can be corrected. Healthcare facilities can continue to use pumps in their possession, guided by the company's instructions. To learn more about the problem with "key bounce", go to http://www.ismp.org/Newsletters/acutecare/articles/20060112.asp

Baxter Healthcare's Colleague Volumetric Infusion Pump and Syndeo Patient Controlled Analgesic Syringe Pump
(posted 7/7/2006)

FDA notified healthcare professionals that Baxter Healthcare will stop manufacturing and distributing all models of Colleague Volumetric Infusion Pump and Syndeo Patient Controlled Analgesic Syringe Pump until the company corrects manufacturing deficiencies and is in compliance with FDA's current good manufacturing practice requirements and the Quality System regulation for devices. FDA will allow the firm to continue to provide routine service maintenance, or to replace components, parts, or accessories for the Colleague and Syndeo Infusion Pumps that were already in the hands of customers before October 12, 2005. The Colleague pump has exhibited a variety of problems, including under-infusion, battery failures, false alarms and failure to alarm.

Baxter Healthcare Corporation COLLEAGUE Volumetric Infusion Pumps
(posted 4/28/2006)

The FDA is recommending that all healthcare providers take important safety steps when using the COLLEAGUE Volumetric Infusion Pump manufactured by Baxter Healthcare Corporation. The COLLEAGUE pump has exhibited a variety of problems, including under-infusion, battery failures, false alarms and failure to alarm. Over the past year, Baxter has issued four urgent safety notices and recalls for COLLEAGUE infusion pumps.

In addition to the recommendations made by Baxter Healthcare Corporation when using the COLLEAGUE Volumetric Infusion Pump, FDA is strongly recommending the following measures:

- Do not use the COLLEAGUE pumps in situations where delaying or interrupting therapy in order to reprogram or replace a malfunctioning pump may be life threatening, if possible.

- Have a contingency plan to mitigate any disruption of infusion therapy (e.g., have a back-up pump available).

- Monitor patients and check the pumps frequently.

- Report any problems as soon as possible to Baxter and FDA.

- Consider evaluating other options for infusion therapy if your facility relies primarily or entirely on COLLEAGUE Pumps.

Advisory for Users of Diastat AcuDial Delivery Systems
(posted 4/3/2006)

The Food and Drug Administration is advising patients with epilepsy and their care givers of a potential hazard caused by cracks in the applicator tips of Diastat AcuDial (diazepam rectal gel) delivery systems. These cracks can result in the leakage of gel during its application, which results in the patient not getting enough of the medicine to control seizures. Caregivers for these patients are advised to call their local emergency response center or 911 for help in any seizure emergency.

Diastat AcuDial pre-filled syringes are designed to deliver diazepam gel rectally in patients with acute repetitive seizures, a condition that, if inadequately treated, can progress to a life-threatening condition in which seizures are continuous. The drug is typically administered by family members or caregivers at home.

Class 1 recall of Baxter Healthcare Corp. COLLEAGUE and COLLEAGUE CX Volumetric Infusion Pump
(posted 2/2/2006)

Baxter Healthcare Corp. and FDA notified healthcare professionals of a Class 1 recall of all models of COLLEAGUE Volumetric Infusion Pumps, used to give controlled amounts of medications or other fluids to patients through an intravenous, intra-arterial, epidural or other direct line into the bloodstream. Reasons for the recall include one or more of the following conditions: battery undercharging, false alarms/shutdown, gearbox wear, under-infusion, and/or non-detection of upstream occlusion. Any of these failures may delay or interrupt therapy, which could result in a life-threatening situation for patients, depending on the type of therapy being administered.

Baxter Healthcare Colleague Volumetric Infusion Pump
(posted 7/21/2005)

Baxter Healthcare Corporation and FDA notified healthcare professionals of a Class I recall of all models of its Colleague Volumetric Infusion Pumps because they can shut down while delivering critical medication and fluids to patients. Baxter has received six reports of serious injury and three reports of death associated with this shut-down problem.