Product News and Recalls

Writer: FDA used flawed risk assessment

In an analysis piece for Forbes, journalist Ed Silverman writes that the U.S. Food and Drug Administration may have used a flawed statistical model in its evaluation of the bleeding risks for the drug Pradaxa.

Pradaxa is a blood thinner, used to prevent blood clots and strokes in patients with atrial fibrillation. The Institute for Safe Medicine Practices has linked the drug to more than 500 deaths and more side effect reports than any other drug, Silverman writes. The drug is also controversial because no antidote exists to reverse its effects in the event of a bleeding emergency.

Even so, Pradaxa has generated more than $1 billion in sales.

The FDA recently released the results of an analysis, which concluded that the bleeding rates are no higher than among patients given warfarin, a standard treatment for blood clot prevention that’s been available for decades.

But in preparing that analysis, the FDA used a method called “unadjusted incidence rate ratios” that the Observational Medical Outcomes Project has identified as flawed.

Silverman notes that the OMOP is a nonprofit tasked with identifying the most reliable methods for analyzing data, which was formed by the FDA itself, along with the Pharmaceutical Research and Manufacturers of America and the Foundation for the National Institutes of Health.

“The FDA is now in a difficult spot and would do well to revisit its reliance on methodology that a team of experts – who were gathered with agency help – have found is lacking,” Silverman writes.

You should consult with a doctor if you have any ongoing symptoms or health concerns, and before making any changes in medication. You should also consult with a lawyer if you have injuries connected with Pradaxa.

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