Did FDA Know About Pradaxa Dangers?

Pradaxa is one of three drugs that has been singled out in a new report that accuses the Food and Drug Administration of approving some medications to go on the market despite unresolved concerns about the dangerous drugs' safety.

According to a report that was recently published in the Journal of the American Medical Association, the FDA’s attempt to speed up the evaluation process of new medications has led to at least three medications’ approval before they had been subjected to proper safety analysis. Among these medications is Pradaxa, The Wall Street Journal reported.

When it came to the approval of Pradaxa, which is used as a an anticoagulant drug to prevent strokes, the authors of the study found that it was known before the drug’s approval that it was associated with a bleeding risk. Furthermore, it was also known that bleeding the bleeding "may be more difficult to treat than warfarin-related bleeding," primarily because there was "no antidote is available for use in bleeding emergencies" that were caused by the drug.

Since its FDA approval and release into the market, Pradaxa has been linked to a number of dangerous bleeding episodes that have resulted in internal injuries and, in some cases, death.

The other two drugs singled out in the study were Caprelsa - a thyroid cancer drug - and Gilenya – which treats multiple sclerosis.

"These examples raise the question of whether it was good policy to approve three innovative new drugs with significant safety questions unanswered," said Thomas J. Moore and Curt D. Furberg, the writers of the study.

If you or a loved one has been harmed by a dangerous drug such as Pradaxa, there may be legal actions worth pursuing. Call Sokolove Law today to learn more about possibly pursuing a dangerous drug lawsuit.

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