FDA Safety Alerts
for Drugs and Medication-Related Medical Devices

Drugs and Therapeutic Biological Products

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.

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

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.