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FDA Drug Safety Communication: Safety review of a reported death after the first dose of Multiple Sclerosis drug Gilenya (fingol

Posted Dec 20 2011 2:19pm




Safety Announcement

[12-20-2011] The U.S. Food and Drug Administration (FDA) has received a report of a patient with multiple sclerosis (MS) who died within 24 hours of taking the first dose of Gilenya (fingolimod). At this time, FDA cannot conclude whether the drug resulted in the patient's death. FDA is continuing to evaluate the case and will communicate any new information that results from this investigation.

Facts about Gilenya (fingolimod)

  • An oral medication for the treatment of relapsing forms of Multiple Sclerosis (MS) in adults.
  • Used to reduce the frequency of flare-ups (clinical exacerbations) and delay physical disability.
  • Available as 0.5 mg oral capsules.

At this time, FDA continues to believe that Gilenya provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Gilenya follow the recommendations in the approved drug label (See Additional Information for Healthcare Professionals).

Patients with MS should not stop taking Gilenya without talking to their healthcare professional.

FDA will communicate any new information on Gilenya and this case when it becomes available.

Additional Information for Patients

  • Gilenya may cause serious side effects, such as slow heart rate (bradycardia), which may be related to slowed conduction of electrical impulses from the upper chambers of the heart to the lower chambers of the heart. These effects usually do not cause symptoms, but they can cause dizziness, fatigue, and palpitations.
  • A slowing of the heart rate due to Gilenya mostly occurs after the first dose, and your heart rate usually returns to normal within 1 month after you start taking the drug.
  • Call your healthcare professional and seek immediate care if you develop any signs or symptoms of slow heart rate such as
    • Dizziness
    • Tiredness
    • Slow or irregular heart beat or palpitations
  • Discuss any questions or concerns about Gilenya with your healthcare professional.
  • Report any side effects you experience to your healthcare professional and the FDA MedWatch program using the information in the "Contact Us" box at the bottom of the page.

Additional Information for Healthcare Professionals

  • If you prescribe Gilenya, carefully follow the recommendations in the Gilenya drug label.
  • Observe all patients for signs and symptoms of bradycardia for 6 hours after the first dose.
  • Obtain a baseline ECG before the first dose if one was not recently performed for those patients at higher risk of bradyarrhythmias.
  • Gilenya has not been studied in patients with ischemic heart disease, congestive heart failure, second degree or higher conduction block, sick sinus syndrome, or prolonged QT interval. Gilenya has not been studied with concomitant use of Class Ia or Class III antiarrhythmic agents. These patients, as well as patients receiving beta blockers, calcium channel blockers, and those with a low heart rate or history of syncope, are at increased risk of developing bradycardia and conduction block. Carefully monitor these patients during initiation of therapy.
  • If Gilenya therapy is discontinued for more than two weeks, the effects on heart rate and atrioventricular (AV) conduction may recur on reintroduction of Gilenya treatment and the same precautions and monitoring as for initial dosing should be followed.
  • Make sure your patients know the signs and symptoms of bradycardia and when to seek care.
  • Report adverse events involving Gilenya to the FDA MedWatch program, using the information in the “Contact Us” box at the bottom of the page.

Data Summary

FDA is evaluating a post-marketing report submitted to FDA's Adverse Events Reporting System (AERS) database regarding a patient who died within 24 hours of taking the first dose of Gilenya (fingolimod). The patient was also treated with metoprolol, a beta blocker, and amlodipine, a calcium channel blocker. The patient had completed 6 hours of monitoring after the first dose without incident, but died less than 24 hours after the first dose. The exact cause of death has not been established. FDA is working closely with the manufacturer of Gilenya (Novartis Pharmaceuticals) to evaluate the post-market report of death.

Gilenya has several known side effects which include a decrease in heart rate and/or atrioventricular conduction after the first dose. Patients receiving Class Ia or Class III antiarrhythmic drugs, beta blockers, calcium channel blockers, those with a low heart rate, history of syncope, sick sinus syndrome, 2nd degree or higher conduction block, ischemic heart disease, or congestive heart failure are at increased risk of developing bradycardia or heart blocks. [See the Gilenya drug label for complete information on Warnings and Precautions ]

At this time, FDA believes the benefits of Gilenya continue to exceed the potential risks when the drug is used appropriately as described in the approved drug label. FDA recommends that healthcare professionals continue to prescribe Gilenya following the recommendations in the drug label.

 

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