Report: Doctors Concerned About Pradaxa Side Effects

Miami, FlA new report suggests some doctors are concerned about Pradaxa side effects, which reportedly include an increased risk of Pradaxa deaths due to bleeding. Concerns have been raised that patients who are given Pradaxa can suffer from uncontrollable bleeding, which puts them at a risk of death even after a relatively minor fall.

The Houston Press (5/23/12) cites the case of Loraine Franklin, who died less than 24 hours after falling on her kitchen floor. Doctors said she died from an intracranial hemorrhage that could not be stopped. Franklin had been taking Pradaxa for atrial fibrillation. Unlike with Coumadin, doctors reportedly have no way of stopping the bleeding when Pradaxa patients suffer a traumatic event, making even something as minor as a fall a life-threatening situation.

Reuters (6/14/12) reports that some doctors are growing concerned about the risk of bleeding associated with Pradaxa, going so far as to recommend thorough monitoring of patients who are prescribed the medication.

Pradaxa was approved by the US Food and Drug Administration (FDA) in 2010 as an alternative to warfarin in the treatment of atrial fibrillation. According to the Institute for Same Medication Practices, approximately 540 reports involving death linked to Pradaxa were made to the FDA in 2011, with 3,781 serious adverse events in total. That is in comparison with only 72 deaths and 1,106 reports overall linked to warfarin. Although warfarin is linked to an increased risk of brain hemorrhages doctors are able to stop traumatic bleeding with an antidote.

Lawsuits have been filed against Boehringer Ingelheim, maker of Pradaxa, alleging patients died as a result of using the medication and that the drug maker did not adequately warn about the risks associated with Pradaxa. The company has so far not commented on the lawsuits.

Meanwhile, the European Medicines Agency (EMA) has requested updated warnings to the Pradaxa label, including information on avoiding bleeding risks when using the medication. Although the EMA noted that the drug's benefits outweighed the risks—and that instances of fatal bleedings were lower than in clinical trials—it stated that more information about the risks should be included on the label.