Gilenya, a multiple sclerosis drug, has recently been linked to 15 deaths, prompting the FDA to launch a new safety review. Some Gilenya patients died from heart problems shortly following their first dose of the medication, raising concerns that the drug may cause cardiovascular problems. The drug’s safety label already recommends that people be monitored for six hours following the first dose.
UPDATE: Gilenya Safety Concerns Highlighted in Report
October 3, 2014 — The Institute for Safety Medication Practices (ISMP) published a QuarterWatch report linking Gilenya with 2,716 adverse events during a one-year period, raising serious safety concerns about its fast-track approval by the FDA. Click here to read more.
August 29, 2013 — The FDA is investigating one case of progressive multifocal leukoencephalopathy (PML), a rare but life-threatening brain disease, reported in one Gilenya patient. Click here to read more.
May 14, 2012 — The FDA has concluded its safety review of Gilenya, and the agency is warning that Gilenya should not be prescribed to patients who have a history of heart attack, stroke, heart problems, or patients who are taking anti-arrhythmic drugs. Furthermore, the FDA is advising that if Gilenya is prescribed to a high-risk patient, the patient should be monitored with an ECG at least overnight following the initial dose. The FDA investigated the sudden death of a 59 year-old, who died soon after taking the first dose of Gilenya. Click here to read more.
April 20, 2012 — Health authorities in the U.S. and Europe have placed new safety precautions on the label of Gilenya, following the deaths of 15 patients. The new labels will warn doctors not to prescribe Gilenya to patients with a history of cardiovascular disease, cerebrovascular disease, or people who take heart-rate lowering medications. If doctors feel that it is necessary to prescribe Gilenya to patients with these risk factors, the heart activity of these patients should be monitored at least overnight after the first dose. Click here to read more.
Gilenya (fingolimod) is a medication used to treat severe multiple sclerosis (MS), a debilitating neurological disease. The medication is produced by Novartis AG, a pharmaceutical company. It is the first oral medication approved to treat multiple sclerosis. More than 30,000 people worldwide take this medication.
Gilenya was approved for sale in the U.S. in 2010. It was approved for sale in Europe in March 2011. In the first nine months of 2011, sales were $291 million.
Novartis announced that one patient had died on November 23, 2011 after starting Gilenya. There have been ten other deaths: six deaths are unexplained, three fatal heart attacks, and one fatal disruption of heart rhythm.
Novartis has previously warned doctors who prescribe this medication that they should monitor their patients for six hours after they take their first dose. Gilenya can cause a person’s heart rate to slow significantly when the first dose is taken (a condition known as “bradycardia”).
Novartis will be changing its recommendations, and will now ask that doctors continually monitor a patient’s heart rate and blood pressure for six hours. The new guidelines will only affect people who have never taken Gilenya. The risk of a cardiovascular event was highest for people taking their first dose.
Ten of the deaths occurred in Europe. One death occurred in the United States, 24 hours after the patient took the first dose of Gilenya. Click here to read the FDA safety communication regarding the death.
FDA and EMA to Review Safety of Gilenya
The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) will conduct separate investigations into the safety of the medication. The EMA said that their review would be finished in March. The FDA did not provide a timeline for conducting the review.
The FDA continues to believe that Gilenya provides an important health benefit to users of the medication when they follow recommendations. It is possible that when the FDA reviews the deaths, they may recommend that Novartis update the safety label. They warn doctors that people who have several types of pre-existing conditions, including low heart rate, may be at an increased risk and should be carefully monitored after the first dose of Gilenya is administered.
Gilenya Side Effects
These serious, life-threatening side effects are detailed in the product’s safety labeling.
- Heart problems
- Heart attack
- Bradyarrhythmia and atrioventricular blocks: Conditions that occur when the electrical impulses between upper/lower chambers of the heart are interrupted.
- Macular edema: Swelling and/or thickening of part of the eye.
- Respiratory effects
- Hepatic (liver) effects
- Progressive Multifocal Leukoencephalopathy (PML)