Pradaxa Bleeding Problems Reported by More than 500 in First Quarter 2011

More than 500 reports of Pradaxa bleeding problems were reported to the FDA in the first quarter of 2011, just months after the drug first hit the market.  

According to a quarterly drug safety report released this week by the Institute of Safe Medication Practices (ISMP), which monitors all serious, disabling and fatal adverse drug events reported through the FDA’s MedWatch program, the number of reported bleeding problems with Pradaxa outnumbered those associated all other drugs monitored by the group.

Pradaxa (dabigatran) is a blood thinner that was just introduced in October 2010, as an alternative to Coumadin (warfarin) for prevention of strokes among individuals with atrial fibrillation.

The drug was heavily marketed as superior to warfarin because it is supposedly easier to use and requires less monitoring. However, when serious bleeding events do occur, warfarin can be quickly counteracted by doses of Vitamin K, while there is no such quick fix for bleeding with Pradaxa.

The ISMP report indicates that there were a total of 932 serious adverse events reported involving Pradaxa problems between January and March 2011. Those reports included 120 deaths, 25 incidents where people were permanently disabled by the drug, 543 incidents of hospitalization and 505 reports of Pradaxa hemorrhages, or internal bleeding.

By comparison, the older and more widely used drug warfarin was associated with 176 reported cases of hemorrhage.

The FDA has launched a safety investigation into Pradaxa side effects along with the manufacturer, Boehringer Ingelheim. The investigation will look into hundreds of Pradaxa bleeding deaths reported worldwide since its release.

As concerns rise among federal regulators and the medical community, a number of lawyers are reviewing potential Pradaxa lawsuits on behalf of individuals throughout the United States, alleging that Boehringer Ingelheim failed to adequately warn about the risk of internal bleeding.