Despite Side Effects Cited in Pradaxa Lawsuits, FDA Says Bleeding Rates No Higher Than in Patients Taking Competing Bloodthinner
In an effort to assuage concerns raised by the mounting number of Pradaxa lawsuits recently filed in federal court, the U.S. Food and Drug Administration (FDA) recently said gastrointestinal bleeding rates in patients taking this popularly-prescribed bloodthinner were no higher than in those who took warfarin, an age-old medical standard.
However, some members of the medical community have their doubts about the accuracy of this statement, which was published by Forbes on Nov. 6. For one, the Observational Medical Outcomes Project, a non-profit organization partially formed by the FDA, pointed out that the agency studied unadjusted incidence rate ratios—which used administrative data and insurance claims—to reach their newfound Pradaxa conclusions.
Meanwhile, the drug prescribed to reduce the risk of strokes and blood clots in atrial fibrillation patients has been connected to approximately 500 deaths and a slew of side effects, which is more than any other drug of its kind, said the Institute for Safe Medicine Practices. Brought by a series of lawsuits recently filed against Pradaxa’s manufacturer, Boehringer-Ingelheim, the drug has been suggested to cause cerebral hemorrhaging, severe bleeding following a small trauma, like a fall, and even death from internal Pradaxa bleeding.
Given the fact that Pradaxa was only approved two years ago by the FDA, the amount of lawsuits already filed over the drug is particularly noteworthy. Pradaxa lawsuits pending in federal court have already been consolidated into the multidistrict litigation, In re: Pradaxa Product Liability Litigation (“MDL No. 2385”) and assigned to Judge David R. Herndon. Proceedings for this MDL are currently underway in the U.S. District Court for the Southern District of Illinois.
It appears doctors are starting to catch on to the dangers of this drug, though—by the end of 2011, 17 percent of atrial fibrillation patients were prescribed Pradaxa, while 44 percent were prescribed the warfarin, another bloodthinner.
Before the FDA formally issued its statement this November, it was announced that the makers of Pradaxa recalled a production lot of the drug after they became aware of a defect in the drug’s packaging, which supposedly decreased the effectiveness of the drug by allowing moisture to get into the bottle.