May 14, 2012 — The FDA is warning that Gilenya, a multiple sclerosis drug sold by Novartis, should not be used in patients who have a history of heart attack, stroke, heart problems, or patients who are taking anti-arrhythmic drugs.

Gilenya has been linked to the sudden deaths of at least 15 people, many of whom died shortly after taking the initial dose of Gilenya.

The FDA launched the safety review after receiving a report regarding the death of a 59 year-old Gilenya patient who died within 24 hours after taking the initial dose of Gilenya.

In the review, the FDA also scrutinized sudden cardiac deaths that occurred during clinical trials of Gilenya, as well as adverse event reports submitted to the FDA.

The agency could not conclude that the 59 year-old patient’s death was directly caused by Gilenya, because the patient also had significant brainstem lesions caused by multiple sclerosis that may have caused sudden death.

Even so, because at least 15 people have suddenly died after taking Gilenya (many for the first time), the FDA remains concerned that some people may be more susceptible to side effects of this medication.

Therefore, the FDA is advising that Gilenya should not be used by patients with a history of heart attacks, strokes, cardiovascular problems, or those who are taking anti-arrhythmic drugs.

Experts already know that one common, life-threatening side effect of Gilenya is a slowing heart-rate (brachycardia). In some patients, the heart-rate may slow too much, leading to irregular heartbeat, cardiac arrest, or death.

To reduce the risk of death, the label on Gilenya already advises that new patients should be monitored for at least 6 hours after the first dose. The FDA will be updating the label to advise that new patients should be monitored with an ECG, blood pressure, and pulse at least overnight.

New patients should also be aware of the symptoms of low heart-beat, which may precede a severe cardiac problem. If the following symptoms occur and a problem is suspected, call 911 immediately:

  • Dizziness
  • Tiredness
  • Irregular heart-beat
  • Palpitations


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