Pradaxa Side Effects

Pradaxa ® (dabigatran etexilate) is a prescription medication manufactured by Boehringer Ingelheim. It was approved by the U.S. Food and Drug Administration in October 2010 for the prevention of stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation). With atrial fibrillation, part of the heart does not beat the way it should. This may cause blood clots to form, increasing a patient’s risk of stroke.

Pradaxa ® is a blood-thinning medication. It is the first in a new class of oral medicines called direct thrombin inhibitors.

In November 2011, Boehringer Ingelheim confirmed reports of 260 people worldwide suffering a fatal bleed while taking Pradaxa.

In December 2011, the FDA issued a safety announcement that it is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa. The FDA is currently investigating reports that bleeding in patients taking Pradaxa are occurring more commonly than would be expected, and more than other blood-thinning drugs.

In January 2012, the results of seven clinical trials involving 30,514 patients also revealed patients taking Pradaxa have a 33 percent higher risk of heart attack or severe symptoms of heart disease than patients taking blood thinner warfarin.

Pradaxa already carries a warning on its label about the risk of significant and sometimes fatal bleeds. Japan and Australia have issued safety advisories about the drug, and stronger warnings were added to the drug’s label in Eurpoe and the United States. However, the drug does not carry the FDA’s strongest “black box warning” and there have been no moves to recall the drug.

From the time of its approval in October 2010 through August 2011, a total of approximately 1.1 million Pradaxa prescriptions were dispensed, and about 371,000 patients received Pradaxa prescriptions from U.S. outpatient retail pharmacies.

The means to stop a catastrophic bleeding situation are limited. Physicians worry internal hemorrhaging in patients taking Pradaxa may be irreversible or current methods for removing the drug from a patient’s bloodstream, such as dialysis, too slow.