Recently unsealed court documents show that Boehringer Ingelheim, the manufacturer of a popular blood-thinning drug Pradaxa, failed to disclose information that indicated the drug had a higher death rate due to bleeding. Instead, the company disclosed only one analysis of data showing that the number of people who died from bleeding was “less than expected,” Bloomberg reports.
Pradaxa (dabigatran) was approved by the Food and Drug Administration (FDA) in 2010 after submitting only the analysis that showed fewer fatal bleeding incidents. The second analysis, showing a higher death rate related to the drug, was not disclosed.
“Having run an analysis in several ways, there is no good reason not to disclose all the results,” Harlan Krumholz, a Yale University cardiologist leading an effort to get companies to fully disclose all their findings, told Bloomberg.
Earlier this month, internal documents made public showed that Boehringer Ingelheim officials were worried about the results of an internal research paper which suggested that patients taking the drug could benefit from regular blood monitoring.
Pradaxa claims to be superior to the existing anti-clotting drug, warfarin, in that it does not require careful monitoring or blood tests. Internal emails, memos, and presentations show the company was concerned that the results of the study, showing careful monitoring would be beneficial, could damage sales.
Boehringer Ingelheim currently faces more than 2,000 Pradaxa lawsuits. Patients taking the drug allege that the company was well aware of the risk of fatal bleeding when it was approved by the FDA. Unlike the existing anti-clotting drug, warfarin, Pradaxa has no antidote to counteract excessive bleeding.
Paradaxa has been linked to more than 1,000 deaths in the United States alone. Since it gained FDA approval in 2010, an unprecedented number of adverse events related to the drug have been reported to the FDA. Experts have also questioned the reliability of an FDA study affirming the safety of Pradaxa.
“If drugmakers are allowed to continue to select the safety information they share with regulators, consumers can’t be sure the disclosures aren’t being driven by financial concerns,” Erik Gordon, a University of Michigan business and law professor, told Bloomberg.