Gilenya to Bear New Label Warnings Following Patient Deaths, Safety Reviews

Novartis has announced that it is modifying the label for Gilenya, its oral multiple sclerosis medication, following safety reviews in the U.S. and Europe. Both the U.S. Food & Drug Administration (FDA) and the European Medicines Agency (EMA) launched Gilenya safety reviews several months ago, after receiving reports of deaths among patients within hours of having taken their first dose of Gilenya.

Gilenya Backgroun

Gilenya was approved for the treatment of relapsing-remitting multiple sclerosis in 2010. It was the first multiple sclerosis drug approved in pill form, and is used to reduce the frequency of multiple sclerosis flare-ups and delay physical disability. Since its approval, more than 30,000 people worldwide have taken Gilenya, according to the FDA.

One of the known side effects of Gilenya is brachycardia, or a slow heart rate. However, according to the FDA, heart rate usually returns to normal within 1 month after patients start taking the drug.

Gilenya Safety Reviews

The FDA announced a Gilenya safety review last December, after one patient died within 24 hours of taking their first dose of Gilenya. European regulators started their review in January, after receiving reports of 10 additional deaths among Gilenya patients. According to the drug’s maker, Novartis, six of those deaths were unexplained, three resulted from heart attacks and one was due to disruption of heart rhythm.

Gilenya Label Changes

In the U.S., the new Gilenya label will warn that:

  • Patients with some cardiac conditions, including heart attack or stroke in the last six months, should not take Gilenya.
  • Patients should have an electrocardiogram before they start using Gilenya, and they should have a second scan six hours after the first dose of the drug as well as addition to hourly monitoring of blood pressure and heart rate. The same monitoring is also recommended for patients whose Gilenya treatment has been interrupted.
  • Some patients with heart conditions or who are taking some other drugs should be monitored overnight after their first dose of Gilenya, and in some cases those patients should be evaluated before treatment.

The European label will be modified to include similar warnings. However, that label will also recommend continuous ECG monitoring for a minimum of six hours following the first dose, Novartis said.

Gilenya Brain Infection Report

Earlier this month, Novartis revealed that one Gilenya patient had been diagnosed with a serious brain infection called progressive multifocal leukoencephalopathy, or PML. Novartis pointed out that the patient in question had previously been treated with Tysabri, an IV-administered multiple sclerosis drug already known to be associated with PML.

“The current assessment is that Tysabri is the drug most likely associated with this case of PML,” Novartis said. “However, a contribution of Gilenya to the evolution of this case can’t be excluded. Novartis said it doesn’t know of any confirmed PML cases in patients treated with Gilenya who hadn’t previously been treated with Tysabri.

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