Gilenya Warning with Label/Insert Update

[Marco]

Novartis is updating label/insert information for both the European Union and American markets.

Prompting by safety concerns by as many as 15 deaths, the drug will get a new warning label and updated insert information.

EU/US - patients with a history of cardiovascular and cerebrovascular disease or who take heart-rate lowering medication


US - Monitoring should be extended for at least two hours in patients whose heart rate is lowest six hours after receiving the first dose of Gilenya


Novartis said Dec. 12 that a U.S. patient died within 24 hours of starting treatment with Gilenya, triggering reviews by the FDA and the EMA, which reported a further 10 deaths among patients taking the medicine. Six of those deaths were unexplained, three patients died of heart attacks and one due to disruption of heart rhythm, the regulator said Jan. 20.