Exposed Pradaxa Analysis Suggests Boehringer Kept Data From FDA
Unsealed court filings suggest that Boehringer Ingelheim GmbH may have failed to disclose critical data indicating serious risks regarding its blood thinner Pradaxa. The company is currently facing 2,000 suits involving the drug.
Boehringer only gave U.S. regulators one data analysis after Pradaxa was approved in October 2010. The analysis showed the number of people who suffered from fatal bleeding due to use of Pradaxa was less than expected, disclosed internal documents showed. Boehringer did not share a second analysis demonstrating a higher death rate. Andreas Clemens, a Pradaxa executive, reportedly acknowledged that the company shared only one of the analyses with the FDA. The FDA was at the time running a safety check on the drug triggered by results seen in adverse incident reports. Clemens allegedly stated that he couldn’t say why only one of the analyses was given to the FDA.
The FDA initially requested that the company establish a death rate by comparing fatal bleeding reports received by the agency against the number of patients using the drug. Boehringer reported a death rate of 6.1 out of every 10,000 patients who used the drug after it was approved. The FDA then asked the company to reanalyze results from a previous study used to win approval and compare its results against the present rate.
One of the two separate analyses conducted in response to the FDA request analyzed only people who died primarily because of bleeding and showed that 5.8 out of 10,000 patients died per year. The other showed a rate of 19.5 deaths out of 10,000 patients per year due to fatal bleeding, but included patients who had a major bleeding event and died for any reason.
According to court filings, only the analysis indicating the death rate from the previous research was much higher than those seen after approval was sent to the FDA. Clemens reportedly said that it would have been possible to disclose both numbers to the FDA. An assessment report in August 2012 from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) stated that selective disclosure of Pradaxa information may have concealed a serious safety signal. EU drug regulators have the drug presently under review while U.S. regulators are planning to conduct another assessment of Pradaxa’s risks and safety as part of its efforts to monitor FDA-regulated drugs.