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.
Gilenya Update 5/17/12: The U.S. Food & Drug Administration (FDA) has completed its evaluation of a report of an individual who died after initiating a regimen of Gilenya. The administration has also evaluated a number of reports of Gilenya users who died of cardiovascular events or unknown causes. Click here to learn more.
Gilenya Update 5/14/12: In response to a mysterious death associated with Gilenya, the FDA issued a warning today stating that patients with certain cardiac risk factors should not take the medication. The death was reported late last year, and the FDA had promised to investigate the event to determine the exact cause of the fatality. Click here to learn more.
Gilenya Update 4/23/12: U.S. and European health regulators have announced plans to place stronger heart risk warnings on the labels of Novartis’ controversial multiple sclerosis drug Gilenya (generic: fingolimod). Both the U.S. Food & Drug Administration (FDA) and the European Medicines Agency (EMA) are recommending electrocardiogram examinations for patients taking Gilenya with a prior history of heart problems, as well as in individuals who are taking medications that lower their heart rates. Click here to learn more.
Free Gilenya Lawsuit Evaluation: If you or a loved one has been injured by Gilenya, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of Gilenya and we can help.
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.
Do You Have a Gilenya Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Gilenya lawsuits. We are handling individual litigation nationwide and currently accepting new Gilenya injury cases in all 50 states.
Free Gilenya Lawsuit Evaluation: If you or a loved one has been injured by Gilenya, you should contact our law firm immediately. You may be entitled to compensation by filing a Gilenya injury suit and we can help.