The FDA announced yesterday that it was beginning an investigation into reports of fatal bleeding incidents associated with the anti-clotting medication Pradaxa. Pradaxa was supposed to be an alternative to the drug warfarin, and early clinical studies seemed to indicate that the risk of serious bleeding was less with Pradaxa than with warfarin, a number of adverse event reports have led the FDA to begin investigation into why the incidence of adverse events should be so much higher in real-world situations than in clinical studies.

According to the drug’s manufacturer, Boehringer Ingelheim, there have been at least 260 fatal bleeding incidents associated with Pradaxa worldwide since the drug’s introduction in 2008. In the US, Pradaxa has only been approved since October 2010, but has already been flagged as having more side effect reports than over 98% of prescription drugs monitored by the Institute for Safe Medication Practices (ISMP), a consumer watchdog group.

One of the problems is that Pradaxa is being prescribed extensively for off-label applications. Although only intended for stroke prevention in patients with atrial fibrillation, the most common form of cardiac arrhythmia. However, two-thirds of patients are being prescribed Pradaxa for other uses, often as a general blood thinner.

It is unknown whether Boehringer Ingelheim’s marketing practices have contributed to the frequent off-label uses. If so, it may add strength to pharmaceutical liability and wrongful death lawsuits associated with the drug later on.

If you have lost a loved one due to a fatal drug side effect, you may be able to receive compensation. Please contact the wrongful death attorneys at Robert W. Kerpsack, CO, LPA for a free case evaluation at our Columbus, Ohio practice.