After Patient Deaths, Novartis Changes Gilenya Label

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After Patient Deaths, Novartis Changes Gilenya LabelOverview: Novartis’ multiple sclerosis (MS) medication Gilenya (fingolimod) has new safety regulations in the United States and Europe. After conducting safety reviews following several patient deaths, regulators agree that Gilenya should not be prescribed to high risk groups, which includes patients with a history of cardiovascular or cerebrovascular disease and patients taking certain heart medications. Additionally, healthcare professionals will increase monitoring on patients’ cardiac health.

  • Patients who have history of heart attack or stroke should not take Gilenya
  • All patients taking Gilenya are to receive an electrocardiogram (EKG) prior to, and six hours after their first dose
  • High risk patients may need to be monitored overnight
  • European and US regulators launched reviews of Gilenya after a patient died within 24 hours of the first dose last December; EMA recently looked at 15 sudden or unexplained deaths

Product: Gilenya (fingolimod)

Manufacturer: Novartis

Side Effects & Complications

  •  Bradycardia (slowed heart rate)

Gilenya’s Updated Safety Information

Gilenya is now contraindicated in US patients who have had a stroke or heart attack within the past six months. Patients taking medications to lower heart rate should also avoid taking Gilenya. Due to the potential risk of heart failure, all Gilenya patients should receive an electrocardiogram before starting the medication and six hours after their first dose. Blood pressure and heart rate should also be monitored on an hourly basis.

The new recommendation also states that some patients, such as those with a heart condition, warrant overnight monitoring after, and in some cases prior to, the first dose.

If patients exhibit their lowest heart rate after the six-hour period, then the observation should be extended by a minimum of two extra hours. If more serious conditions, such as slowed heart rate or conduction problems occur, patients should be monitored until the problem is resolved; in these cases, observation should continue at least overnight.

The European Medicines Agency (EMA) discussed the latest review, which investigated 15 deaths associated with the MS drug. “Most of the deaths and cardiovascular problems had occurred in patients with a history of cardiovascular problems or taking other medicines,” the agency told Bloomberg Businessweek.

Background: Gilenya-Related Deaths Cause Serious Concerns

The U.S. Food and Drug Administration (FDA) approved Gilenya in 2010 to treat multiple sclerosis. The drug drew concerns last December, when a patient died within 24 hours of the the first dose; the report resulted in safety reviews by both US and European regulators, who later reported an additional 10 Gilenya-related deaths. Four of these patients died due to cardiac complications and the other six were unexplained.