Pradaxa Bleeding Risk Analysis Concealed from FDA

February 26, 2014 — Bloomberg News reports that Boehringer Ingelheim concealed a data analysis linking Pradaxa (dabigatran) to more fatal bleeding events than another study that was used to win the drug’s approval.

According to internal company documents made public in lawsuits, Boehringer gave the U.S. Food and Drug Administration (FDA) a favorable analysis that showed there were less fatal bleeding events, and did not disclose a second analysis showing a higher death rate.

Boehringer provided an analysis showing that 6.1 patients in 10,000 died from fatal bleeding after Pradaxa was approved in October 2010. When the FDA requested data from before October 2010 (the RE-LY clinical trial), one analysis showed that 5.8 patients in 10,000 died from fatal bleeding. However, they did not disclose another analysis showing that people who had a major bleeding event and died for any reason was 19.5 in 10,000.

Boehringer Ingelheim is now facing more than 2,000 lawsuits involving Pradaxa and severe bleeding events. Plaintiffs allege that drug-makers knew about the increased risk of bleeding, but failed to adequately warn doctors, the FDA, and patients. Unlike warfarin, which can be counteracted with Vitamin K, Pradaxa has no reversal mechanism.

Since Pradaxa was approved, it has been blamed for 1,158 deaths and 12,494 serious injuries, according to Tom Moore, senior scientist for the Institute for Safe Medication Practice. In 2011 and 2012, the FDA received more complaints about Pradaxa side effects than any other drug.

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