What is Pradaxa’s History with the Food and Drug Administration (FDA)?

The relationship between Pradaxa and the FDA began with approval for a specified use — as a drug prescribed for patients who had irregular heartbeats (arterial fibrillation) to prevent strokes and blood clots. The FDA issued approval in October 2010, based on a clinical trial that compared Pradaxa with warfarin (Coumadin), another anticoagulant drug that had the same use. Pradaxa works by inhibiting thrombin, an enzyme in the blood that causes clotting. The clinical trial reported that patients taking Pradaxa had fewer strokes than patients taking warfarin. Even at this point, the FDA acknowledged the side effects associated with Pradaxa, including “life-threatening and fatal bleeding,” along with gastrointestinal symptoms, stomach pain, nausea, heartburn, and bloating. The FDA based approval on the condition that the company would include a Medication Guide warning about side effects, to be distributed to patients when filling prescriptions.

Two years later in November 2012, the FDA released an alert about “Serious Bleeding Events” and indicated that bleeding rates were higher than rates associated with warfarin. The FDA did not change its Pradaxa recommendations, but indicated it was continuing to investigate and evaluate Pradaxa. About a month later, in December 2012, the FDA issued a Safety Alert that Pradaxa should not be used in patients with mechanical heart valves. The FDA reported that, based on a European clinical study, patients with mechanical heart valves were more prone to suffering from strokes, heart attacks and blood clots that formed on the mechanical heart valves than warafin users. Bleeding was also more excessive with Pradaxa than warafin.

The last Pradaxa FDA warning and further investigation may lead to exposing more dangers linked to Pradaxa.

Phillips Law Offices works with clients to recover compensation in Pradaxa cases.