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FDA Announces New Gilenya Restrictions

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The U.S. Food & Drug Administration just announced new Gilenya restrictions. Gilenya (fimgolimod) was approved in 2010 for the treatment of relapsing-remitting multiple sclerosis (MS).

The first MS pill medication, Gilenya is used to reduce the frequency of MS flare-ups and delay physical disability. However, reports of patient deaths have prompted concerns.

Now, said the FDA, Gilenya should not be prescribed for patients diagnosed with some pre-existing conditions, recent heart conditions, or stroke. Gilenya should also not be prescribed for patients taking specific drugs to correct heart rhythm issues, said USNews. Additional clinical trial and post-approval Gilenya data was also reviewed, as were reports of patient deaths from cardiovascular or unknown causes.

Last December, the FDA announced a Gilenya safety review following the death of one patient in the first 24 hours of taking the first Gilenya dose. European regulators initiated their review in January, after receiving reports of 10 more deaths in Gilenya patients. Novartis said that six of those deaths were unexplained, three resulted from heart attacks, and one was due to heart rhythm disruption. Since Gilenya was approved, more than 30,000 people worldwide have taken Gilenya, said the FDA.

Although Gilenya could not be definitively connected to the deaths, the FDA announced that it is concerned about the drug’s cardiovascular effects following the first dose. Analysis revealed that while most rate-lowering Gilenya effects typically occur within the first six hours of taking the fist dose, the effect can take place up to 20 hours following the first dose, explained USNews.

The FDA said that all patients starting Gilenya should be monitored for signs of a slow heart rate for a minimum of six hours following the first dose and undergo hourly pulse and blood pressure measurements. Patients should also undergo electrocardiogram testing before receiving Gilenya and after the observation period, said USNews. Extended cardiovascular monitoring should continue overnight for patients with increased risk or low tolerance for bradycardia (slow heart rate). This includes those who develop severe bradycardia following the first Gilenya dose, those with pre-existing conditions in whom bradycardia may be poorly tolerated, and patients receiving therapy with other medications that slow the heart rate or electrical impulses that regulate the heartbeat. Patients diagnosed with QT interval prolongation—a heart rhythm abnormality—before initiating Gilenya or during the cardiovascular monitoring period following the first dose are considered at high risks as are patients taking other medications that prolong the QT interval or that can lead to Torsades de pointes, a life-threatening, abnormal heart rhythm, said USNews.

Patients experiencing dizziness, fatigue, irregular heartbeat, or palpitations (signs of a slowing heart rate), while taking Gilenya, should seek medical attention, said the FDA; patients should not stop taking Gilenya without first speaking with their physician, wrote USNews.

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