Amid Lawsuits, Pradaxa Again Tops FDA's Adverse Event Reports for 2012

Of the 700 drugs monitored by the U.S. Food and Drug Administration, Pradaxa again led the agency’s list of adverse event report for 2012.

Deaths and hemorrhages were among the most serious side effects reported by Pradaxa users, with nearly 20 percent of the reports citing fatalities, according to an annual report issued by the Institute for Safe Medication Practices (ISMP). The number of deaths reported in Pradaxa users is up seven percent from 542 deaths in 2011 to 582 deaths in 2012, the report said.

By changing the one-dose-fits, the FDA could reduce the risk of serious or fatal hemorrhages.

With a total of 3,292 adverse event reports, Pradaxa’s risks tower over other anticoagulants it was originally designed to replace, including warfarin. According to the ISMP report, this year warfarin prompted a total of 861 adverse event reports, including 56 deaths, a number which is down from the reported 72 deaths in 2011. Unlike warfarin, no antidote exists to reverse the anti-clotting effects of Pradaxa, leaving users at a much higher risk for serious, life-threatening bleeding.

Despite only being available for two years, Pradaxa has remained at the top of the FDA’s adverse event report list during its entire lifespan on the market. The ISMP report claims that the FDA has failed to take Pradaxa seriously, calling their response “disappointing” and claiming that “the FDA’s many actions to discount mounting safety concerns about anticoagulant adverse effects remain unexplained.” Despite acknowledging the drug’s risks, the FDA continues to recommend that Pradaxa be used as directed. By changing the “one-dose-fits all strategy” for Pradaxa and providing physicians with better information for managing the risks of anticoagulant drugs without an antidote, the FDA could reduce the risk of serious or fatal hemorrhages, according to the ISMP.

Since 2012, Pradaxa users have filed lawsuits against the drug’s manufacturer, Boehringer Engelheim, alleging that the company failed to provide an antidote for the blood thinner or an adequate warning on the drug’s label. In 2012, the lawsuits were consolidated into a multidistrict litigation, which now has about 1,600 cases pending in federal court, where plaintiffs allege bleeding in the gastrointestinal tract, brain, and kidneys as a result of using the anticoagulant.