The Novartis-made multiple sclerosis drug Gilenya (generic: fingolimod) has been found to cause dangerously slow heart rates when taken by certain patients. The European Medicines Agency (EMA) is currently investigating whether Gilenya played a role in at least 11 deaths in users of the drug. Worldwide, more than 30,000 patients have been prescribed Gilenya to treat the symptoms of multiple sclerosis.
What’s the problem?
American and European health agencies are investigating reports of at least 11 deaths in multiple sclerosis patients taking Gilenya, the first MS drug to be approved in pill form.
Gilenya was approved by the European Union in 2011 to treat a severe type of multiple sclerosis. The drug was subsequently reported to cause an abnormally slow heart rate when first taken, and doctors were advised to closely monitor patients after the first dose. The EMA said the risk of a slow heart rate after the first dose was known when Gilenya was approved.
Of the 11 fatalities linked to Gilenya, one occurred in the United States, in which the patient died within a day of taking the first dose. Ten more patients taking the drug have died, due to sudden death, heart attack or disruption of the heart rhythm. The EMA has stated that it doesn’t yet know where the other 10 deaths occurred, but that they were reported to a European database that monitors drug-related adverse events. According to Novartis, not all the fatalities involving Gilenya were heart-related.
The U.S. Food & Drug Administration (FDA) is currently conducting its own data analysis on Gilenya, but as of yet has not made any definitive conclusions regarding the safety and efficacy of the drug.
The EMA has notified physicians to increase their monitoring of patients after their first dose of Gilenya. Novartis is currently in the process of advising doctors of new recommendations on using the drug. The company previously said that all patients should be closely monitored for six hours after their first dose, but that recommendation is now being updated to include perpetual heart monitoring using electrocardiograms, and measuring blood pressure and heart rate every hour. In certain high risk patients, the monitoring should be extended for a longer period of time.
Gilenya Side Effects
Gilenya is a sphingosine l-phosphate receptor modulator drug used to slow the worsening of multiple sclerosis in patients with relapsing forms of the disease. The drug is designed to work by decreasing the action of immune cells that may cause nerve damage. Gilenya has been reported to cause the following side effects in certain users:
- slow heart rate
- slow or pounding heartbeat
- chest pain
- excessive tiredness
- sore throat, fever, chills, cough, and other signs of infection
- eye pain
- blurriness, shadows, or a blind spot in the center of your vision
- sensitivity to light
- unusual color to your vision
- shortness of breath
- loss of appetite
- stomach pain
- yellowing of the skin or eyes
- dark urine
The FDA is recommending that before patients begin a regimen of Gilenya, they are made aware of the potential for these types of side effects. The administration is further recommending that patients only take Gilenya at their doctor’s office, where they are to be monitored for at least six hours after their first dose.