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Schachter, Hendy & Johnson, Attorneys At Law

Did the FDA Approve Pradaxa Too Quickly?

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Following the serious and even deadly Pradaxa side effects that have occurred, many in the medical community are concerned that the Food and Drug Administration (FDA) may have rushed to approve Pradaxa, which is used to treat patients with atrial fibrillation, without evaluating the life-threatening risks of the dangerous drug. 

Thomas J. Moore and Curt D. Furberg, the writers of an article in the Journal of the American Medical Association, are raising this question. Why did the FDA rush to approve Pradaxa “with significant safety questions unanswered?” 

However, Janet Woodcock, the FDA’s director for drug evaluation and review, defended their approval process of Pradaxa. She told the Wall Street Journal that 16 medications approved by the FDA in 2011 were Priority Reviews (a faster review process), and three of those medications were approved with the fast-track approval process. 

Pradaxa was one of the drugs that were approved during a shortened review process in 2010, which occurred prior to conclusion of clinical safety trials. Now many are wondering if the rush to approve this blood thinner put patients in jeopardy.

As litigation is approaching, this question of whether the medication was approved too quickly could be used in upcoming Pradaxa lawsuits. If you or your family member was affected by Pradaxa, talk with a Northern Kentucky Pradaxa lawyer for help holding Boehringer Ingelheim, the drug maker, accountable for their negligent actions. You can reach the Law Office of Schachter, Hendy & Johnson at (859) 578-4444 or (888) 606-5297 for a complimentary consultation today.

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