Drug Safety Alert on Novartis MS Drug Gilenya

A new FDA drug safety alert is warning that when Novartis’ multiple sclerosis (MS) drug Gilenya (fingolimod) is stopped, the disease can become much worse than before therapy started. “This MS worsening is rare but can result in permanent disability,“ the agency says. In response, FDA has ordered a new warning about this risk to the prescribing information and a patient Medication Guide.

Gilenya was originally approved in 2010. To date, FDA says it has identified 35 cases of severely increased disability accompanied by the presence of multiple new lesions on magnetic resonance imaging that occurred two to 24 weeks after Gilenya was stopped. Most patients experienced this worsening in the first 12 weeks. “Our analyses include only reports submitted to FDA and those found in the medical literature, so there may be additional cases about which we are unaware,” the agency says.