January 11, 2014 — Documents unsealed in federal court last week indicate that Boehringer Ingelheim, the manufacturer of the controversial blood-thinning drug Pradaxa (dabigatran), may have concealed conclusions from a study suggesting that some patients may need blood tests while using Pradaxa.
One of Pradaxa’s selling points is that it does not need routine blood tests, unlike warfarin, the 60 year-old blood-thinner that Pradaxa is designed to replace. Pradaxa is marketed as a “one size fit all,” once-daily pill.
Unfortunately, the study indicated that some people — especially older patients — could have higher risks of bleeding, stroke, blood clots, and death, according to a repot by the New York Times.
Risk-factors for bleeding or stroke on Pradaxa:
- Kidney dysfunction
- Older age
- Low body weight
- Female sex
- Previous stroke
- Longer use of Pradaxa
- Aspirin use
The author of the study, Paul A. Reilly, indicated that some patients might need blood testing. Everyone metabolizes Pradaxa differently, and a minority of patients could develop extremely high concentrations in their blood (which would increase the risk of bleeding) or extremely low concentrations (which would fail to prevent blood clots and stroke).
However, after company leaders and researchers debated the issue, safety concerns were drowned out by concern about Boehringer Ingelheim’s bottom line and legal repercussions. When the study was published in the Journal of the American College of Cardiology this month, the conclusions omitted any recommendation on blood testing.
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