JAMA Article Criticizes FDA for Accelerated Approval of Pradaxa

Ennis & Ennis, PA Continues to Offer Free Nationwide Confidential Consultations to Pradaxa Bleed Victims
Sept. 5, 2012 - PRLog -- In an article in the acclaimed Journal of the American Medical Association (JAMA), drug safety experts Thomas Moore and Dr. Curt Furberg advise that the Food and Drug Administration’s push to get medicines approved may have compromised prescription drug safety.  [1] This FDA effort to speed approval of certain new medications, including Pradaxa, allowed certain drugs onto the market without proper safety analysis.

Author Thomas J. Moore is a director of QuarterWatch, an independent drug-safety publication that evaluates side-effect data reported to the FDA. Dr. Furberg is emeritus professor of medicine at Wake Forest University and a researcher on clinical studies. They both question whether it was good policy to approve Pradaxa and two other innovative new drugs with significant safety questions still unanswered.

The authors noted that Pradaxa is in some ways easier to use than the other standard anticoagulant medications such as warfarin (Coumadin.)  However, bleeding with Pradaxa patients, “may be more difficult to treat than warfarin-related bleeding” because there is, “no antidote available for use in bleeding emergencies” linked to Pradaxa use.

Since its launch in 2010, Pradaxa, manufactured by Boehringer Ingelheim, has been linked to thousands of adverse event reports and hundreds of cases of fatal bleeding.  Although the FDA is still reviewing case reports, European regulators have already asked for label changes.

Ennis & Ennis, P.A. continues to offer free, nationwide, confidential consultations to anyone who took Pradaxa and suffered an internal bleeding event by calling toll free 1-800-856-6405 or by going to www.ennislaw.com and completing an online case evaluation form. Ennis & Ennis, P.A. is a nationwide law firm with offices in Ft. Lauderdale, Miami and Washington D.C. that concentrates its practice in mass torts and represents individuals against pharmaceutical companies and medical device makers.

[1] http://jama.jamanetwork.com/article.aspx?articleid=1356361
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