Gilenya Warning Labels Updated to Include Cardiac Risk Factors

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May 14, 2012 – In response to a mysterious death associated with Novartis’ widely-prescribed multiple sclerosis drug Gilenya (generic: fingolimod), the U.S. Food & Drug Administration (FDA) issued a warning today stating that patients with certain cardiac risk factors should not take the medication. The death was reported late last year, and the FDA had promised to investigate the event to determine the exact cause of the fatality. First approved by the FDA in September 2010, Gilenya is the first oral treatment indicated for relapsing forms of multiple sclerosis in the United States.

What’s the problem?

In its press release, the FDA stated that it was still uncertain as to whether Gilenya caused the patient’s death, but out of an abundance of caution had decided to add new contraindications to the drug’s label, as well as updated recommendations for monitoring patients after dosing.

According to the updated warning label, patients with the following conditions should not take Gilenya:

  • Major cardiovascular events within the past 6 months, including MI, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or class III/IV heart failure;
  • History or presence of Mobitz type II 2nd- or 3rd-degree atrioventricular heart block or sick sinus syndrome, unless the patient has a pacemaker;
  • Baseline QTc interval of 500 ms or more;
  • Treatment with class Ia or III antiarrhythmic drug.

Additionally, the FDA stated that individuals at risk for bradycardia should be monitored for an extended period of time after being treated with Gilenya. Bradycardia was recognized as a potential complication of Gilenya when it was initially approved in 2010, but concerns grew more serious after the patient death was reported last year.

“Extended monitoring should include continuous ECG monitoring that continues overnight,” the administration said in its warning.

In addition to taking Gilenya, the patient who died was also being treated with the beta-blocker metoprolol and the calcium channel antagonist amlodipine. These drugs have been linked to an increased risk for bradycardia and heart blockage. The patient did well through the six-hour monitoring period, but died a few hours later.

In its press release, the FDA stated that in a new review of clinical trial data, Gilenya’s cardiac effects may peak as late as 20 hours after the initial dose in certain patients, although they usually occur within the first six hours.

“FDA concluded that it would be prudent to extend the monitoring period beyond 6 hours in patients who experience a heart rate of less than 45 beats per minute in the first 6 hours, or in those who had their lowest heart rate at 6 hours post-dose, as further bradycardia is still possible after 6 hours,” according to the announcement.

The FDA concluded by encouraging patients to consult their physicians immediately if they experience dizziness, tiredness, palpitations, or irregular heartbeats while taking Gilenya.

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