UPDATE 1-EU agency widens safety review into Sanofi's Multaq

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Mon Jul 11, 2011 10:48am EDT

* Follows cardiovascular problems in some patients

* Experts to consider need for action next week (Adds details on review)

LONDON, July 11 (Reuters) - The European Medicines Agency said on Monday it was widening a review into the safety of Sanofi's heart drug Multaq after a study revealed severe cardiovascular events in some patients.

Europe's drugs watchdog first initiated a probe into the risks associated with Multaq in January following two cases of liver failure in patients on the drug.

Concerns about the medicine increased last week, however, when the French drugmaker reported a higher rate of adverse events and hospitalisations with Multaq when compared with placebo in patients with permanent atrial fibrillation.

Analysts see Multaq, which won approval from European medicines regulators in September 2009 and was approved in the United States in July 2009, as an important driver for Sanofi to see it through patents expiries on multibillion-dollar drugs like the cancer treatment Taxotere and the blood thinner Plavix.

The agency said its review of Multaq had been extended to assess the new clinical study findings and its experts would determine the need for any further action at their next meeting on July 18-21.

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