Novartis Agrees To Stricter Safety Measures For MS Drug

Law360, New York (April 20, 2012, 2:18 PM EDT) -- Novartis AG will revise the safety guidelines for multiple sclerosis drug Gilenya following discussions with U.S. and European regulators prompted by sudden deaths of patients using the medicine, the firm announced Friday.

The Swiss firm said discussions with the U.S. Food and Drug Administration led it to update Gilenya labels to recommend all patients have an electrocardiogram before starting treatment and after the six-hour observation period that follows the first dose.

In addition, the company now recommends overnight monitoring after the first dose for patients taking...
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