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Report Casts Critical Light on FDA’s Speedy Approval of Boehringer Ingelheim’s Pradaxa, Other Allegedly Risky Drugs

Originally hailed as an innovative warfarin replacement, Pradaxa is part of a new generation of anticoagulants that has been associated with uncontrollable bleeding risks.

Sep 6, 2012 | Parker Waichman LLP

Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective drugs, is informing the public about a new report in the Journal of the American Medical Association (JAMA) that analyzes the risks of expedited approval for drugs such as Pradaxa. According to the report, Pradaxa was approved without proper safety evaluation. Since its recent approval, the drug has raised serious safety concerns over reports of internal bleeding, for which there is no antidote.

According to the report, the U.S. Food and Drug Administration (FDA) approved 16 out of 35 drugs using some type of shortened review process for the fiscal year of 2011. The authors, Dr. Curt Furberg and Thomas J. Moore, point out the risks that come with expedited approval. Using Pradaxa and other medications as an example, the authors stated that several newly approved drugs are released onto the market with “limited clinical data and substantial risks."

The FDA approved Pradaxa to prevent stroke in patients with atrial fibrillation (AF), a condition that causes an irregular heart rhythm. When initially launched, it was considered innovative because, as an article published on September 4th in Wall Street Journal points out, “Pradaxa is in some ways easier to use than the decades-old competing anticoagulant, warfarin." Warfarin is an older anticoagulant that requires frequent monitoring and dietary restrictions. While Pradaxa lacks these limitations, the authors emphasized that side effects such as internal abdominal bleeding and cerebral hemorrhaging "may be more difficult to treat than warfarin-related bleeding," because "no antidote is available for use in bleeding emergencies.”

The fact that there is no effective way to stop Pradaxa’s bleeding side effects means that even minor trauma can lead to fatal complications. This critical risk was highlighted in March by the Journal of Neurosurgery; the journal published a case report of a Pradaxa patient who died of a cerebral hemorrhage after a ground level fall in his home.

The ISMP’s latest QuarterWatch report showed that Pradaxa was named in more adverse event reports than any other drug last year. In addition to being named in the greatest number of overall reports, the anticoagulant was associated with the greatest number of deaths, strokes, acute kidney failures and hemorrhage.

Parker Waichman LLP is offering free lawsuit consultations to victims of Pradaxa bleeding side effects. If you or a loved one took Pradaxa and experienced a life-threatening bleeding event, please contact their office by visiting the firm's Pradaxa traumatic bleeding page at Free case evaluations are also available by calling 1-800-YOURLAWYER (1-800-968-7529).

For more information regarding Pradaxa bleeding lawsuits and Parker Waichman LLP, please visit: or call 1-800-YOURLAWYER (1-800-968-7529).

Parker Waichman LLP
Gary Falkowitz, Managing Attorney
(800) 968-7529

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