Boehringer Ingelheim's new anti-clotting pill Pradaxa may be linked with 256 deaths from fatal bleeding, but European regulators believe that the risk can be managed. The Committee for Medicinal Products for Human Use issued a safety update after its latest meeting this week, saying last month's new treatment guidelines should be enough to address safety concerns.
In October, the EU called for additional monitoring of those taking Pradaxa, including kidney-function tests before treatment and annual assessment in certain patients after that. Renal function is important because levels of the drug's active ingredient can build up if the kidneys aren't clearing it properly, leading to a higher risk of serious bleeding.
The CHMP said the number of bleeding-related deaths "has to be seen in the context of the rapidly increasing use of Pradaxa worldwide." The drug has been approved since 2009 to fight certain clots after surgery, but only recently won clearance as a stroke-prevention treatment--and that market is much larger. The new indication has triggered broader use, the CHMP figures. Increased awareness about the drug is probably also a factor, the committee said.
"The CHMP is of the opinion that the recommended changes to the use of Pradaxa adequately manage the risk of bleeding," the group said in a statement. "The agency will continue to monitor this issue and the overall safety profile of Pradaxa." Of the 256 deaths worldwide linked to the drug, 21 occurred in the EU.
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