Report Blasts FDA for Pradaxa Approval

Boston, MAGiven that the risk of Pradaxa side effects includes the possibility of uncontrolled bleeding, some patients might be surprised to know that Pradaxa was given a speedy approval by the US Food and Drug Administration (FDA). A new article, however, suggests that the risks associated with Pradaxa bleeding are enough of a concern that the drug should have been subject to a proper safety study.

The article was published in the September 5, 2012, issue of the Journal of the American Medical Association (JAMA) and written by Thomas J. Moore and Curt D. Furberg. The authors note that of 35 new drugs introduced in the 2011 fiscal year, 16 received one or more expedited approval programs, meaning they had shortened review times. Thirteen drugs were designated for the Fast Track program, in which reviews of the drug begin before clinical studies are finished, "and 3 drugs received Accelerated Approval, a program that relies on preliminary but not definitive evidence of benefit." One of those three drugs was Pradaxa.

The authors further note that because of the risk of side effects, and the potential compromise of drug safety that occurred because of the Accelerated Approval, there is a question as to whether the FDA should have approved the three drugs while "significant safety questions" remained unanswered.

Pradaxa is an anticoagulant approved to reduce the risk of stroke and blood clots in patients who have atrial fibrillation. The issue with Pradaxa is unlike its successor, warfarin, there is no antidote. So a patient who bleeds while on Pradaxa runs a risk of uncontrollable bleeding that can cause permanent injury and even death. Warfarin could also cause uncontrollable bleeding, but there was an antidote in the form of vitamin K.

Patients who begin bleeding on Pradaxa can be put on dialysis, but beginning dialysis is time-consuming. According to one attorney, patients who developed uncontrollable bleeding on Pradaxa suffered injuries such as cerebral hemorrhage, kidney bleeds and heart attacks.

When Pradaxa was introduced on the market in 2010 it was touted as being superior to warfarin. In December 2011, the FDA issued a Drug Safety Communication about Pradaxa, warning about the risk of serious bleeding events, including fatal events. At the time, the FDA noted that it was analyzing the Adverse Events Reporting System to determine whether bleeding events occurred more commonly than expected.