QuarterWatch: Monitoring MedWatch Reports
QuarterWatch monitors domestic, serious adverse drug events reported to the FDA. We identify trends in drug safety,
report signals for specific drugs, and seek to improve the system.
April 2012
***CURRENT ISSUE***
Signals for Fingolimod (GILENYA) and Infliximab (REMICADE)
In this issue we analyze signals for severe side effects associated with two different but important drugs that suppress elements of the human immune system, fingolimod (GILENYA) for multiple sclerosis, and infliximab (REMICADE) for ulcerative colitis, rheumatoid arthritis, and other autoimmune disorders. We also update our findings for dabigatran (PRADAXA) and metoclopramide (REGLAN).
In the second quarter of 2011 the Food and Drug Administration (FDA) received 40,222 reports of domestic, serious adverse events, including reports of 6,617 patient deaths. The total was similar to the previous quarter (an increase of just 32 cases) and 20% higher than the same quarter in the previous year. The trend continued of increasing numbers of reports from drug manufacturers, with a more rapid increase in reports from consumers, compared with health professionals. In the same period, IMS Health data showed that total dispensed outpatient prescriptions totaled 911 million, a decline of 2.8% from the previous quarter, and an increase of 0.8% from the same quarter of 2010.
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January 2012
Signals for Dabigatran (PRADAXA) and Metoclopramide (REGLAN)
QuarterWatch 2011 Quarter 1 This issue examines a strong signal for serious bleeding with the new anticoagulant drug dabigatran (PRADAXA) and investigates reports of brain damage associated with metoclopramide (REGLAN), a drug for reflux and other gastrointestinal disorders. In addition, we review the quarterly data for the five most widely prescribed drugs in the United States, revealing results that reflect upon the safety of the most popular and essential drugs as well as providing a perspective on how the monitoring system works.
In the first quarter of 2011, the U.S. Food and Drug Administration (FDA) received 40,151 domestic reports of serious, disabling or fatal injury associated with drug therapy. The total represented a 3% increase over the previous calendar quarter, and a 19.5% increase over the first quarter of 2010. The typical drug we monitor accounted for a median of six reports in a quarter. At the other extreme, 10 drugs each accounted for 500 or more case reports of serious injury in the quarter. Meanwhile, the number of dispensed outpatient prescriptions in the first quarter totaled 938 million, a 1% increase from the previous quarter and a 3% increase from the same quarter of 2010, according to the IMS Health National Prescription Audit™ for 2011.
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October 2011
Signals for Two Newly Approved Drugs and 2010 Annual Summary
QuarterWatch 2010 Quarter 4 In this issue we examine signals for two recently approved drugs and report the case totals for the full calendar year. We analyze reports for dabigatran (PRADAXA) involving its effects on blood clotting, examining cases of too much anti-clotting effect (hemorrhages) and too little clot inhibiting effect (reported thromboembolic events). For the new drug for multiple sclerosis, dalfampridine (AMPYRA), we examine case reports that suggest that some patients report it makes it more difficult to walk while the intended benefit was to improve walking speed. In addition we update our reporting on the smoking cessation drug varenicline (CHANTIX) and dronedarone (MULTAQ), a drug for heart rhythm disorders. We also examine patient death reporting for the pulmonary hypertension drug bosentan (TRACLEER).
For the full calendar year of 2010, we identified 141,829 new cases of serious, disabling or fatal adverse drug events reported to the U.S. Food and Drug Administration, a 21% increase over the 117,093 cases in 2009. The increase of 24,736 cases in 2010 was the largest absolute increase since 1998, although the percentage increases were greater in 2002 (26%), 2003 (25%) and 2008 (27%). In the same period, total dispensed outpatient prescriptions increased by 1.1%, from 3.6 to 3.64 billion, according to IMS Health Inc. data.
The annual results also include a ranking of the drugs most frequently associated with reports of serious injury. Prominent were opioid pain medications, blockers of Tumor Necrosis Factor (TNF), acetaminophen, the antibiotic levofloxacin (LEVAQUIN), and the antipsychotic quetiapine (SEROQUEL).
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May 2011
New Signals for Liraglutide, Quetiapine and Varenicline
QuarterWatch 2010 Quarter 3 The new diabetes drug liraglutide (VICTOZA) was approved in January 2010 after a debate at the FDA over its safety profile. We examine a signal for pancreatitis for liraglutide, and compare it to other chemically-related drugs. A growing number serious adverse event reports for quetiapine (SEROQUEL) were associated in part with its expanding use as a general psychiatric treatment outside its core indication for psychosis. A major adverse event reporting problem with varenicline (CHANTIX) led to its risks of psychiatric side effects—including completed suicide—being underestimated in adverse event data. We also ask the FDA to investigate Pfizer’s handling of 150 cases of completed suicide and scores of suicide attempts associated with varenicline.
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January 2011
Signals for Varenicline, Levofloxacin and Fentanyl
QuarterWatch 2010 Quarter 2 A year after the FDA required new safety measures, varenicline (CHANTIX) continued to account for large numbers of three reported serious psychiatric side effects. We analyze why levofloxacin (LEVAQUIN) had more reports of serious injury than other antibiotics. Maladministration of fentanyl patches were a prominent safety issue featured in a new section, Drug Safety Perspectives. We also update findings on Johnson & Johnson’s OTC product recalls and describe new safety questions about the heart drug dronedarone (MULTAQ).
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November 2010
Acetaminophen, Dronedarone and Botulinum Toxin Products
QuarterWatch: 2010 Quarter 1 This report describes new safety signals for acetaminophen products, potential safety concerns about a new heart drug dronedarone (MULTAQ), and increased reports of complications for botulinum toxin products (BOTOX, BOTOX Cosmetic, DYSPORT)
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June 2010
Reported Patient Deaths Increased by 14% in 2009
QuarterWatch: 2009 Quarter 4 In the full year of 2009 reported patient deaths associated with drug therapy increased by 14% compared to 2008, and were up 3-fold since 2000. Three factors contributed to the increase: a) higher awareness of drug risks increased reports for drugs such as rosiglitazone and digoxin, b) risks for some high-alert drugs continued unabated, and c) more drug company contact with consumers led to reporting problems. We also examine Johnson & Johnson’s massive recall of Tylenol products and reports of problems with that company’s fentanyl patches.
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February 2010
Did a Cold Remedy Cause Thousands to Lose Their Sense of Smell?
QuarterWatch 2009: Quarters 1:3 The FDA received hundreds of reports in which two Zicam brand cold remedies were blamed for loss of the sense of smell, sometimes permanently. The products were Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Gel Swabs, both of which contained zinc. We also examine signals for rosiglitazone (AVANDIA), quetiapine (SEROQUEL) and testosterone (ANDROGEL, TESTIM).
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October 2009
Serious Adverse Drug Event Reports Increase 25% in 2008
QuarterWatch: 2008 Quarter 4 Serious, disabling and fatal adverse events reported to the FDA increased by 25% for the full year of 2008, the largest increase since the beginning of our historical data in 1998. The biggest identifiable safety factor in the increase was reports associated with the massive recalls of generic drugs that occurred throughout the year. We also found that approximately half the increase occurred because of more voluntary reporting to the FDA, and from certain manufacturers. While the FDA added important new black black box warning for varenicline (CHANTIX) and psychiatric side effects, a better and clearer warning about accident risk is needed. Given the association of varenicline with aggressive, violent and hostile behavior we recommend that the ban on varenicline be extended from pilots and missile crews to all active duty military personal, police and emergency workers.
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May 2009
More than 1000 patient deaths reported after digoxin recall
QuarterWatch: 2008 Quarter 3 More than 1000 patient deaths have been reported in connection with the recall of the heart drug digoxin, but a year later no testing has been performed to determine how many are directly linked to defective tablets. For the third quarter of 2008 reported serious, disabling adverse drug events were 30.5% higher than the same quarter one year ago, but little changed from previous quarters. More than 100 cases of serious injuries were reported in connection with a muscle relaxant (Lioresal Intrathecal) that is delivered to the spinal fluid through an implanted pump. We recommend that the Medication Guide for varenicline (Chantix) should be strengthened to include warnings about risk of vehicle and other accidents, and of psychiatric side effects involving aggression and violence towards others.
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