Pharmaceutical

Authors say FDA approved Pradaxa before safety was established

pradaxa Authors say FDA approved Pradaxa before safety was establishedAn effort by the Food and Drug Administration (FDA) to expedite the approval of new drugs for serious medical conditions has allowed some medications to be cleared with inadequate testing to determine safety and efficacy, two drug safety experts claim in an article in the Journal of the American Medical Association.

Thomas J. Moore, director of the drug safety publication QuatertWatch, and Curt D. Furberg, emeritus professor of medicine at Wake Forest University, say the FDA’s efforts to speed medications to patients have compromised prescription drug safety. One example they cite is the blood thinner Pradaxa, which was approved in late 2010 to prevent strokes in patients with atrial fibrillation.

Pradaxa was thought to be a safer alternative to the decades-old warfarin, but it has since been associated with thousands of adverse reactions including serious bleeding events and deaths.

All blood thinners carry a risk for hemorrhages, some of which can be fatal. However, the authors say that bleeding with Pradaxa patients “may be more difficult to treat than warfarin-related bleeding.” This is based on the knowledge that there is no antidote to reverse the clotting effects of Pradaxa, leaving doctors few alternatives to stop bleeding events when they occur. There are reversal agents already on the market to counter the effects of warfarin.

Boehringer Ingelheim, makers of Pradaxa, have not said whether an antidote is in the works. Instead, the company is focusing on the drug’s ability to prevent strokes and blood clots in atrial fibrillation patients.

Several lawsuits have been filed against the drug company by people who say they were injured by Pradaxa and were never warned that there was no reversal agent for the blood thinner.

Source: WSJ