Gilenya is a multiple sclerosis medication used by roughly 30,000 people worldwide. Recently, it has been linked to the deaths of 11 people worldwide, which has prompted the FDA to launch an investigation. Several patients died of heart troubles shortly after they took their first dose of the medication.

UPDATE: Gilenya Linked to Liver Failure, Deadly Encephalitis, Meningitis

In January 2021, Health Canada issued a Drug Safety Alert for Gilenya with warnings about liver injuries, liver failure, and the need for a liver transplant. In November 2020, similar warnings were issued by the European Medicines Agency (EMA).

In the U.S., the FDA updated the label on Gilenya in November 2020 to include stronger warnings about liver toxicity, including acute liver failure that requires a liver transplant.

In the U.K., health regulators also issued a warning about liver injuries from Gilenya. They also added warnings about reports of viral infections that led to deadly brain inflammation: “Fatal cases of encephalitis and meningitis caused by herpes simplex and varicella zoster viruses have also been reported during treatment.”

FDA Warning: Stopping Gilenya Can Significantly Worsen Multiple Sclerosis

November 26, 2018 — The FDA is a warning about severe worsening of multiple sclerosis after stopping the drug Gilenya (fingolimod).

The disease can become much worse than before the medicine was started or while it was being taken. This MS worsening is rare but can result in permanent disability.”

Patients who have been instructed to stop Gilenya should contact a healthcare professional immediately if they experience new or worsening symptoms of multiple sclerosis, such as weakness, trouble using arms or legs, or changes in thinking, eyesight, or balance.

Gilenya Safety Concerns Highlighted in Report

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.

FDA Links Gilenya and Progressive Multifocal Leukoencephalopathy

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.

FDA: Gilenya Linked to 15 Deaths

At least 15 people have died after taking Gilenya. These deaths have prompted health regulation authorities in Europe and the United States to place new safety warnings on the label of Gilenya.

The updated warnings will advise doctors not to prescribe Gilenya to patients who have a medical history of cardiovascular problems, cerebrovascular problems, or people who are taking heart-rate lowering drugs. If a doctor feels that the benefits of using Gilenya outweigh these risks, they are advised to monitor the heart-rate of a new patient at least overnight after the first dose.

What is Gilenya?

Gilenya (fingolimod) is a pharmaceutical drug prescribed to treat multiple sclerosis (MS), a severely debilitating neurological disorder. It is produced and sold by Novartis AG, a massive pharmaceutical drug company. It is the first oral mediation approved to treat MS, and it is relatively new. It was approved by the U.S. FDA in 2010, and approved in Europe in March 2011. From January 2011 to September 2011, sales were $291 million.

Gilenya Deaths

So far, the FDA and the EMA are aware of 11 deaths in patients following their first dose of Gilenya. Ten of the deaths were in Europe; one death was in the U.S. Six of the deaths were unexplained; three died of a heart attack; one died of a fatal heart rhythm problem.

The drug company behind Gilenya is already aware that the medication can cause serious cardiovascular problems in patients taking the drug for the first time. One severe side effect is a condition known as “bradycardia,” in which a person’s heart rate slows significantly.

Following the reports of deaths, Novartis has decided to update its safety recommendations to doctors prescribing Gilenya to their patients. They will now be asking doctors to use an electrocardiogram to monitor the electrical rhythm of a patient’s heart for the first six hours following the initial dose. Doctors will also be asked to monitor blood pressure. The risk of dying after taking Gilenya is highest in first few hours after the initial dose.

Though Novartis recommends that physicians monitor their patients for six hours, the person who died in the United States suffered a serious cardiovascular event within 24 hours after the initial dose. Click here to read the FDA safety communication regarding the death.

FDA and EMA to Review Safety of Gilenya

The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have announced that they will be reviewing safety information from these recent deaths to determine whether the drug’s safety labeling needs to be changed. The agencies will be conducting separate reviews in light of the deaths.

The EMA announced that it would probably complete its study in March 2012. The FDA did not say when its review would be complete.

The FDA did say that patients taking Gilenya should not stop taking the medication without talking to their healthcare provider. They continue to believe that Gilenya provides people suffering from MS with an important health benefit when the recommendations are followed.

It is possible that the FDA and the EMA will ask Novartis to update these safety recommendations. Until then, they recommend that doctors carefully monitor patients who have pre-existing conditions that increase their risk of serious cardiovascular problems following a dose of Gilenya. People who already have a low heart rate, for example, should be closely monitored, because only of the most serious side effects of Gilenya is that it lowers a person’s heart rate during the first six hours.

Gilenya Side Effects

These serious, life-threatening side effects are detailed in the product’s safety labeling.

  • Bradyarrhythmia and atrioventricular blocks: Conditions that occur when the electrical impulses between upper/lower chambers of the heart are interrupted.
  • Infections
  • Macular edema: Swelling and/or thickening of part of the eye.
  • Respiratory effects
  • Hepatic (liver) effects
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