Approving Too Quickly? Drug Safety and the FDA

In October, 2010, the U.S. Food and Drug Administration (FDA) approved the drug dabigatran to reduce the risk of blood clots and stroke in patients with atrial fibrillation. Marketed as the twice-daily miracle drug Pradaxa, dabigatran is now suspected in more than 540 patient deaths and thousands of drug injuries.

Side effects of Pradaxa are serious, disabling and potentially fatal. Patients prescribed Pradaxa may suffer internal bleeding, hemorrhage, kidney failure and other disorders. In September of this year, the Journal of the American Medical Association (JAMA) questioned whether the FDA compromised drug safety by approving Pradaxa without more rigorous safety testing.

Quoted in Forbes Magazine, the authors of the JAMA report cited approval of three drugs — one of which was Pradaxa — despite significant, unanswered safety questions.

In a field dominated by warfarin (Coumadin) for decades, Pradaxa is a dangerous option. While warfarin bleeds are treated with infusions of Vitamin K, hemorrhaging caused by Pradaxa has no known antidote.

What about access to improved treatment?  And what about a cursory review of potentially deadly drugs?  In the search for safe treatment of atrial fibrillation, patients injured by Pradaxa might say the FDA moved too fast.

But awareness of the danger of Pradaxa is ever-increasing. The FDA surprised the medical and financial communities in June by delaying the approval of the next new anticoagulant drug, Eliquis. Setting a new approval date of March, 2013, the FDA continues to review drug studies provided by manufacturers Pfizer and Bristol Myers Squibb.

If you have suffered uncontrolled bleeding as a side effect of using Pradaxa, please contact our office to discuss your injuries and your legal options.