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Gilenya Lawsuit | Lawsuits, Lawyer, Attorney | Side Effects : Bradycardia, or Slow Heart Rate, Dizziness, Fatigue, Palpitations | Treatment of relapsing-remitting multiple sclerosis

Gilenya Lawsuits Due To Side Effects | Lawsuit, Lawyer

Gilenya Lawsuit | Lawsuits, Lawyer, Attorney | Side Effects : Bradycardia, or Slow Heart Rate, Dizziness, Fatigue, Palpitations | Treatment of relapsing-remitting multiple sclerosis

Do you know someone who died unexpectedly while taking the multiple sclerosis drug, Gilenya? Gilenya is currently being reviewed by regulators in the U.S. and Europe, following the sudden deaths of several patients being treated with the drug. If someone you love died suddenly after starting treatment with Gilenya, you may be entitled to receive damages for medical bills, lost wages, pain and suffering, and wrongful death.

Lawyers at Parker Waichman LLP who specialize in defective drug litigation are currently investigating potential lawsuits on behalf of Gilenya victims and their families, and we are offering free legal evaluations to the families of anyone who died unexpectedly while taking Gilenya. If someone you love died after using this drug, we urge you to contact one of our Gilenya lawyers today to protect your legal rights.

Gilenya Deaths

Gilenya was approved for the treatment of relapsing-remitting multiple sclerosis in 2010.  It was the first multiple sclerosis drug approved in pill form, and is used to reduce the frequency of multiple sclerosis flare-ups and delay physical disability. Since its approval, more than 30,000 people worldwide have taken Gilenya.

One of Gilenya's known side effects is bradycardia, or slow heart rate. According to the U.S. Food & Drug Administration (FDA), these effects usually do not cause symptoms, but they can cause dizziness, fatigue, and palpitations. A slowing of the heart rate due to Gilenya mostly occurs after the first dose, and the heart rate usually returns to normal within 1 month after patients start taking the drug.

In December 2011, the FDA announced it was conducting a Gilenya safety review after one patient died within 24 hours of taking their first dose of Gilenya. In January 2012, the European Medicines Agency (EMA) announced it was also conducting a Gilenya safety review, after the maker of the drug, Novartis AG, confirmed that 10 more fatalities had occurred among Gilenya patients, including six unexplained deaths, three heart attacks and one due to disruption of heart rhythm.

In announcing its safety review, the EMA advised doctors to increase patient monitoring after the first dose of Gilenya is given. That includes electrocardiograms before treatment and for the first six hours after the first dose, and then checking blood pressure and heart rate every hour, the EMA said. After six hours, patients with a slow heart rate or problems with electricity conduction in the heart should be watched until their condition has improved.

Legal Help for Victims of Gilenya

If someone you love died suddenly after using Gilenya, you may have valuable legal rights. To learn more about the legal remedies available to you, please fill out our online form, or call 1-800-YOURLAWYER (1-800-968-7529) today to discuss your case with one of our Gilenya lawyers.


GilenyaRSS Feed

FDA Warns of Gilenya Patients who Developed Brain Infection

Aug 5, 2015
The U.S. Food and Drug Administration (FDA) is updating the label on Gilenya, a drug used to treat multiple sclerosis, to include patients who developed a type of brain infection. According to a Drug Safety Communication posted on the agency's website on August 4, a case of definite progressive multifocal leukoencephalopathy (PML) and a probable case of PML have been linked to patients taking Gilenya. These are the first reported PML cases linked to Gilenya users who had not been previously...

MS Drug Gilenya May Increase Risk for Lymphopenia

Dec 30, 2014
New research studies from Sweden and Germany indicate that underweight women with multiple sclerosis who take the MS drug Gilenya (fingolimod) seem to be at increased risk for lymphopenia. The drug also poses a risk for patients who have low lymphocyte levels before they start drug treatment. Lymphopenia (also known as lymphocytopenia) is a condition in which a person has a deficiency of lymphocytes, which are a subset of white blood cells (leukocytes). Lymphocytes play a crucial role in...

U.K. Regulators Issue Gilenya Heart Warning

May 22, 2012 | Parker Waichman LLP
Health officials in the United Kingdom are following a trend set by domestic regulators in issuing a health warning on the multiple sclerosis (MS) drug Gilenya (fingolimod) because it poses the risk of serious complications, especially for patients with prior heart trouble. According to a release from the Medicines and Health Regulatory Agency (MHRA) in the U.K., Gilenya can cause transient bradycardias and heart block in patients shortly after taking the first dose of the...

Gilenya Subject to New FDA Restrictions

May 15, 2012 | Parker Waichman LLP
The U.S. Food & Drug Administration (FDA) warned yesterday that Gilenya should not be used in some patients, including those with certain pre-existing or recent heart conditions or stroke, or those taking certain medications to control abnormal heart rhythms.  The new Gilenya restrictions follow the FDA's launch of a safety review in December, after the agency learned of one death that occurred within a 24 hours of a patient receiving a first dose of Gilenya. According to the FDA, it...

Gilenya Warnings Updated Following Sudden Death Reports

Apr 23, 2012 | Parker Waichman LLP
Following safety reviews in the U.S. and Europe, Novartis said it has agreed to add additional label warnings to its multiple sclerosis drug, Gilenya.  The Gilenya safety reviews were launched in response to reports of sudden death among patients treated with Gilenya.According to  statements from the company, the labels for Gilenya in the U.S. and Europe will now recommend that all patients have an electrocardiogram (ECG) before taking their first dose of the drug. In addition, the...

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