FDA Takes Heat for Fast-Tracking Pradaxa

In a recent article published in the Journal of the American Medical Association (JAMA), researchers reviewed the safety records of Pradaxa, as well as several other drugs that received approval under one of the FDA expedited approval programs designed to fast-track certain drugs to the market. According to the researchers, Pradaxa, multiple sclerosis drug Gilenya, and thyroid cancer drug Caprelsa, each “raise the question of whether it was good policy to approve three innovative new drugs with significant safety questions unanswered and with optimal doses not determined.”

The researchers specifically mentioned the bleeding risk associated with Pradaxa, as well as its lack of an antidote, and said that bleeding in patients taking the blood thinner may be harder to treat than bleeds related to the older blood thinner warfarin. The article concluded that Pradaxa raised enough concern that the drug should have been subject to stricter scrutiny than the speedy approval by the FDA.

The researchers claim that Pradaxa, which is used to reduce the risk of stroke and blood clots in patients with atrial fibrillation, went through priority review and was thus fast-tracked by the FDA. According to the FDA, the purpose of the fast-track process is to introduce important, new medications to patients more quickly.

Unlike warfarin, Pradaxa did not require weekly doctor check-ups and dietary restrictions and was seen as the first replacement of the difficult-to-use blood thinner. Since its introduction into the market, however, Pradaxa has been the center of a storm regarding reports of serious bleeding. In 2011 alone, the drug was responsible for 3,781 adverse events reports, more than any other drug monitored by the FDA.

Since the news of the negative affects of the drug came to light, Pradaxa has been in the spotlight as dozens of lawsuits have been filed against the drug’s manufacturer, Boehringer Ingelheim. Patients have alleged that the drug led to serious and even fatal hemorrhaging, a problem that they say they were never properly warned about.

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Source: “The Safety Risks of Innovation: The FDA’s Expedited Drug Development Pathway,” by Thomas J. Moore, published at JAMA.com.