Boehringer Ingelheim will pay $650 million in a comprehensive settlement over its anticoagulant dabigatran. The company faced thousands of lawsuits in the U.S. from patients who claimed the drug caused severe and fatal bleeding.

Dabigatran (Pradaxa), a direct thrombin inhibitor, received FDA approval in October 2010 to reduce the risk of stroke in patients with atrial fibrillation. The FDA based its decision in part of results from the RE-LY (Randomized Evaluation of Long-term anticoagulation therapY) trial. RE-LY found that, compared with warfarin, dabigatran at a 110 mg had similar rates of stroke and systemic embolism and lower rates of major hemorrhage. At the 150 mg dose, it had lower rates of stroke and systemic embolism but similar rates of major hemorrhage as warfarin.

Post-marketing reports have differed on the drug’s safety profile, with the FDA maintaining its position while other researchers have reported increased bleeding risk.

In a statement, Boehringer’s U.S. senior vice president and general counsel said the company stood behind dabigatran. Boehringer Ingelheim “believed from the outset that the plaintiffs’ claims lacked merit,” Desiree Ralls-Morrison said, but settled to “to avoid the distraction and uncertainty of lengthy litigation and focus on our mission of improving patients’ lives."

Through the settlement the company expected to resolve the more than 4,000 lawsuits filed against it, but added that it would challenge those that don’t accept the terms.

Boehringer Ingelheim is headquartered in Ingelheim, Germany, with a U.S. subsidiary in Ridgefield, Conn.