The United States Food and Drug Administration recently announced it is evaluating reports of serious bleeding events in patients taking the blood thinning medication Pradaxa (dabigatran etexilate mesylate) after the drug went on the market. Pradaxa is a blood thinning (anticoagulant) medication made by Boehringer Ingelheim used to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF), the most common type of heart rhythm abnormality.
According to the FDA’s announcement, the number of reports of severe bleeding in patients taking Pradaxa via their Adverse Events Reporting System database are greater than the results from an 18,000 patient clinical trial that lead to the approval of the drug. According to Cardiology Today, “the FDA and Boehringer Ingelheim are working together to analyze postmarketing reports for evidence of inappropriate dosing, use of interacting drugs or other clinical factors that may lead to a bleeding event.” Bleeding may lead to serious or even fatal outcomes, and is a well known complication with all anticoagulant therapies. On November 12, Business Week reported that the maker of Pradaxa, Boehringer Ingelheim, said the drug “has been linked to 260 deaths worldwide.”
Despite these reports, the FDA says “patients with AF should not stop taking Pradaxa without talking to their healthcare professional. Stopping use of blood thinning medications can increase their risk of stroke. Strokes can lead to permanent disability and death.” The International Business Times quotes Boehringer Ingelheim’s statement that, “The clinical effectiveness and favorable safety profile of Pradaxa is positive and remains unchanged in light of recent reports about fatal cases of bleeding in the media.”
The FDA “continues to believe that Pradaxa provides an important health benefit when used as directed,” and the agency will communicate new information on the risks for bleeding with the drug as it becomes available.
While using any prescription drug – including the drug Pradaxa – may have side effects, consumers have a reasonable expectation that their treatment plan should be more helpful than harmful. If you or a loved one suffered severe side effects from a prescription drug, a defective drugs lawyer may be able to help you pursue compensation. Call 1-888-BURNETTI for more information.