Manufacturer Hid Information on Dangers of Popular Anticoagulant from FDA

From Ring of Fire:

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.

You can read the full article here at Ring of Fire.