Was Pradaxa Bleeding Risk Information Withheld from the FDA?

Documents released during litigation against the manufacturer of the blood-thinning drug Pradaxa indicate that the company supplied U.S. Food and Drug Administration (FDA) regulators a more positive report regarding Pradaxa-related bleeding deaths, but withheld another report that painted a less rosy picture for the drug.

Concerned by growing adverse event reports linked to Pradaxa after the drug’s approval in 2010, the FDA had asked Boehringer Ingelheim GmbH to supply more data as part of a safety review the agency was conducting. According to the released documents filed in court, the German-based drug company gave the FDA one analyses that indicated Pradaxa-related deaths were actually less frequent than expected, while not providing the FDA with another analyses that showed a much higher death rate – nearly four times that of the analysis the company had forwarded to the FDA.

A Boehringer executive who oversees Pradaxa did not deny that the company withheld the more negative analyses, but told the court that he couldn’t say why that had happened.

A Yale University cardiologist, who is leading an effort to get drug companies to share their data fully with regulators, told Bloomberg, “Having run an analysis in several ways, there is no good reason not to disclose all of the results.”

A Boehringer spokeswoman replied in an email to Bloomberg that the company gave the FDA the analysis it considered the more appropriate comparison for what the agency was seeking.

Currently, there are more than 2,000 lawsuits involving Pradaxa. Patients and their families contend that Boehringer knew that the drug posed a deadly risk due to uncontrolled bleeding when it was approved, but failed to warn.

When it was approved in 2010, Pradaxa was hailed as an alternative to warfarin because it required less monitoring than warfarin after it was administered. While uncontrolled internal bleeding can result from use of both drugs, warfarin has an antidote, while Pradaxa does not.

The first case to be tried under the consolidated federal suits is slated for August. Boehringer has been ordered to pay a $1 million fine for withholding or destroying files the court was seeking concerning the drug’s marketing and development.

If you or a loved one has been harmed from Pradaxa use, or if you have lost a family member due to uncontrolled bleeding after the drug was administered, please contact the pharmaceutical litigation attorneys at Farah & Farah in Jacksonville. You may be entitled to compensation for medical bills, hospitalization, pain and suffering, and wrongful death. Call us toll-free at (800) 533-3555 or contact us online to set up a complimentary review of your case.