January 18, 2011 / 7:32 AM / 8 years ago

EU to ask Sanofi to advise doctors on Multaq-paper

PARIS, Jan 18 (Reuters) - European medical authorities will ask French drugmaker Sanofi-Aventis (SASY.PA) to write to healthcare professionals in Europe about possible risks related to its Multaq heart drug, La Tribune reported on Tuesday.

The Committee for Medicinal Products for Human Use, part of the European Medicines Agency (EMA), will make the request this week after Sanofi confirmed on Friday two patients suffered liver failure after taking the drug. [ID:nLDE70D17V]

Sanofi said no causal link had been established with the medicine.

“We are also going to recommend a change in the wording of the instructions on the product,” La Tribune quoted the EMA as saying.

The U.S. Food and Drug Administration said on Friday it had received several reports of liver injury in patients taking Multaq. The agency said it was “continuing to review reports of possible adverse events and drug interactions” with Multaq. Sanofi was not available to comment. (Reporting by James Regan; Editing by Dan Lalor)

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