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Pradaxa Tops FDA’s List for Serious Adverse Events


According to an analysis by the Institute for Safe Medication Practices, Pradaxa drug (Dabigatran) topped the list of direct reports to the FDA for serious adverse drug events in 2011.  Pradaxa took the lead with 817 direct reports, followed by Coumadin (Warfarin) with 490 direct reports, Levaquin (Levofloxacin) with 393, Carboplatin with 376, and Zestril (Lisinopril) with 351.

The QuarterWatch medical surveillance program is designed to keep track of any serious and/or fatal adverse drug events. QuarterWatch is published by the Institute for Safe Medication Practices, a Pennsylvania-based nonprofit organization that monitors adverse drug events reported to the FDA.  The reports are funded by the institute and are based on the analysis of excerpts that the FDA releases from its Adverse Event Reporting System for research use.  According to QuarterWatch, the FDA received 179,855 reports of serious, disabling, and fatal adverse drug events in the U.S. in 2011.  This number is up 9.4% from 2010.  Eighty-eight percent (88%) of the adverse event reports were submitted by drug manufacturers, and the remaining 12% were submitted by health professionals and patients.  It has long been believed that the FDA adverse event database may only capture less than 1% of the serious injuries and deaths that have been caused by medical devices and drugs in the United States.

Cerebral Hemorrhage

According to adverse event data analysts, Pradaxa resulted in 542 cases of patient deaths, 2,367 cases of hemorrhage, 291 cases of acute renal failure, 644 cases of stroke, and 15 cases of suspected liver failure.  Pradaxa had a total of 3,781 adverse event reports in 2011.  In 2011, Coumadin had 1,106 cases overall, 72 of those resulting in death.  In the QuarterWatch report, the authors wrote: “Two drugs that inhibit the formation of blood clots ranked first and second among all direct reports to the FDA in 2011, emphasizing that the combination of a vulnerable patient population and a powerful pharmacological action rank among the highest risks in prescription drug therapy.”  This data is also very telling in that part of Boehringer Ingelheim’s aggressive sales pitch to encourage Pradaxa prescriptions to doctors and consumers was to create fear about the safety of Coumadin. Apparently, patients and doctors should be far more fearful of Pradaxa.

By filing numerous reports with the FDA, consumers and health professionals singled out the dangers of Pradaxa. This further bolstered the underlying concerns of many that the blood thinner is simply not safe and has been improperly promoted for use in a number of patients with atrial fibrillation for which Coumadin was a better (and safer) choice.  No patient or his doctor can make accurate decisions about the risks of a drug versus the benefit, especially when the raw data regarding patient injuries and deaths is not readily available.  This recent data from QuarterWatch is a big first step in giving prescribing physicians the critical risk information that they need to assist patients in making informed choices about whether the perceived convenience of taking Pradaxa is really worth even a fraction of the now-known (and perhaps escalating) risks of the drug.

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