Gilenya, a multiple sclerosis drug, has recently been linked to 11 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.

What You Can Do & How a Gilenya Lawsuit Can Help

The Schmidt Firm, LLP is currently accepting Gilenya induced injury cases in all 50 states. If you or somebody you know suffered heart problems or died after taking this medication, you should contact our lawyers immediately for a free Gilenya lawsuit consultation. Please use the form below to contact our Dangerous Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

Gilenya Overview

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.

Gilenya Deaths

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 persons 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 patients 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.

• 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

Do I have a Gilenya Lawsuit?

The Schmidt Firm, LLP is currently accepting Gilenya induced injury cases in all 50 states. If you or somebody you know has experienced a side effect or died after taking Gilenya, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Gilenya Lawsuit Group or call toll free 24 hours a day at (866) 920-0753.

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