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FDA: Pradaxa not linked to excess bleeding risk
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An FDA evaluation of new information indicated that bleeding rates associated with dabigatran do not appear to be higher than those associated with warfarin, according to a drug safety communication issued by the agency.
After approval of the dabigatran (Pradaxa, Boehringer Ingelheim), the FDA received a large number of post-marketing reports of bleeding among users of the drug. Consequently, the agency investigated the actual rates of gastrointestinal bleeding and intracranial hemorrhage for new users of dabigatran vs. new users of warfarin. Researchers used insurance claims and administrative data from the FDA’s Mini-Sentinal pilot of the Sentinel Initiative to perform the assessment. The results, which suggest that bleeding rates associated with dabigatran do not significantly exceed those of warfarin, are consistent with data from the RE-LY trial — the large clinical trial upon which the FDA based its approval.
The FDA has not changed its recommendations regarding dabigatran.
As part of an ongoing safety review of dabigatran, the FDA is also conducting two planned, protocol-based observational assessments that will assess patients taking dabigatran and evaluate bleeding events.
Dabigatran is an anticoagulant medication used to reduce the risk for stroke and blood clots in patients with nonvalvular atrial fibrillation.