Sanofi expects EMA to require Multaq alert

European regulators are likely to spur Sanofi-Aventis to alert physicians about new data on possible safety risks of its Multaq atrial fibrillation treatment. The company said it expects the European Medicines Agency to recommend a notification for doctors and patients similar to last week's "Dear Doctor" letter in the U.S.

Friday, Sanofi confirmed that two Multaq patients had suffered liver failure while using the drug. The company said it plans to change the drug's label and recommend that doctors check patients' liver function before prescribing Multaq. No causal link has been found between the drug and liver damage, the company stressed.

European regulators told La Tribune that they would ask Sanofi to write to doctors across Europe about Multaq. "We are also going to recommend a change in the wording of the instructions on the product," the agency told the newspaper. There's no word yet on whether that recommendation involves liver-function testing. Meanwhile, regulators in Canada say they're monitoring the situation and will inform healthcare professionals if necessary.

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- see the CBC story

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