Boehringer Ingelheim has agreed to pay $650 million to wrap up thousands of lawsuits claiming Pradaxa, an anticoagulant, caused serious--even fatal--bleeding in some patients.
The deal comes just weeks after the FDA completed a safety review of the drug, concluding that it was as safe as the older drug it seeks to replace, warfarin.
The Germany-based drugmaker said it stands behind the clot-fighting drug's safety. The settlement deal will allow it to avoid the cost and effort of long-running litigation, Boehringer said in a statement.
The company said it's seeking to resolve 4,000 claims with the $650 million deal.
Pradaxa, the first in a new group of anticoagulants aiming to take the place of warfarin, has racked up thousands of reports of serious side effects since its U.S. launch in 2010.
Boehringer added a warning to its label in 2011, urging doctors to test patients' kidneys before starting Pradaxa therapy, because subprime function could lead to a buildup of the drug in the bloodstream.
But the company--and now the FDA--have assured doctors and patients that the drug is safe when used as directed.
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