ISMP Says Pradaxa Had the Most Complaints in 2011-2012

March 14, 2014

The ISMP (Institute for Safe Medication Practices) released a recent study, claiming that Pradaxa (Dabigatran Etexilate) is the most complained about medication in the United States.  Tom Moore, the senior scientist for drug safety and policy at the ISMP, says Pradaxa has been blamed for 1,158 deaths and 12,494 serious injuries in the US, since it’s FDA approval in 2010.

Numerous plaintiffs have come forward, leading to multidistrict litigation, (MDL 2385), taking place in the Southern District of Illinois.  The most serious allegations claim that the anti-coagulant drug caused patients to suffer severe internal bleeding and hemorrhaging.  According to Tom Moore, “there was an opportunity to make Pradaxa safer; instead, it appears the commercial instincts to sell more drugs won out.”

Unlike older blood thinners such as Warfarin, Pradaxa has no FDA approved antidote.  According to Dr. Michiel Coppens (vascular medicine specialist at the Academic Medical Center, in Amsterdam) “From the very first launch of these drugs, there has been an immediate concern about what do we do if a patient [has] major bleeding.”  Dr. Jonathan Piccini, a cardiologist with Duke University Medical Center, says “It’s always easier to prescribe a therapy if you feel you have a bailout strategy.”  According to Reuters, an antidote may be on the way.

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