The U.S. Food and Drug Administration (FDA) has recently been made aware of the potentially fatal side effects associated with a trending multiple sclerosis medication. Subsequently, officials at the FDA received a report of a patient with multiple sclerosis who died within 24 hours of taking their first dose of Gilenya (generic: fingolimod). Upon further review, the FDA remains concerned for certain populations over the potential for adverse cardiovascular effects following the first use of Gilenya.
Gilenya was developed by Novartis, a worldwide leader in the pharmaceutical industry, where it received approval from the FDA on September 21, 2010. Subsequently, upon its release, Gilenya became the first once-daily pill for reducing the number of relapses in people with relapsing forms of multiple sclerosis. While it does not treat MS, it does reduce the frequency of relapse symptoms.
Fingolimod, the active ingredient found in Gilenya, is capable of sequestering lymphocytes in lymph nodes, preventing them from moving to the central nervous system for autoimmune responses in multiple sclerosis. By preventing lymphocytes from reaching the central nervous system, autoimmune responses are avoided and the nerves remain intact. In doing so, Gilenya reduces flare-ups and muscle deterioration that accompany multiple sclerosis.
Of significant concern, however, is the potential for adverse cardiovascular effects in patients who already exhibit signs of existing heart conditions. Compounding this concern is the recent death of a patient who died after their first dose of Gilenya. Upon being made aware of this unfortunate incident, the FDA conducted its own evaluation of the questionable multiple sclerosis medication and included it in a recent Drug Safety Communication.
The agency has also evaluated additional clinical trial and postmarket data for Gilenya, including reports of patients who died of cardiovascular events or unknown causes. The FDA could not definitively conclude that Gilenya was related to any of the deaths. However, based on their reevaluation of the data, the agency remains concerned about the cardiovascular effects of Gilenya after the first dose.
The data obtained from the evaluation shows a disturbing trend of lowered heart rates within 6 hours of the first dose. However some patients may show a maximum effect as late as 20 hours after the first dose. Accordingly, the increased propensity for lowered heart rates has caused the FDA to advise against its use in select populations, especially those with existing heart conditions, stroke, or who are taking certain antiarrhythmic medications
Do I Have a Gilenya Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Gilenya lawsuits. We are currently accepting new cases in all 50 states.
If you or a loved one has been injured by Gilenya, you may be entitled to financial compensation. For a free case review, please click the link below or call toll free 24 hrs/day 1-800-773-0849.