Gilenya (generic: fingolimod) is a prescription medication intended to treat relapsing forms of multiple sclerosis (MS) in adults. While not a cure for MS, Gilenya may prove successful in reducing subsequent flare-ups and physical deterioration. However, the introduction of Gilenya may result in catastrophic complications. Patients who receive Gilenya treatment may significantly increase their risk of developing severe, life-threatening side effects, the most serious of which is a drastically lowered heart rate.
If you or a loved one has been injured by Gilenya, you should contact our lawyers immediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.
Gilenya Lawsuit Overview
Gilenya is a relatively new prescription medication that was developed by Novartis, a global leader in the pharmaceutical industry. The revolutionary immunosuppressant was approved by the U.S. Food and Drug Administration (FDA) on September 21, 2010. During its brief stint on the U.S. market, Gilenya has assisted in the treatment of relapsing multiple sclerosis (MS). 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. Subsequently, Gilenya is capable of reducing flare-ups and muscle deterioration through this mechanism of action.
Unfortunately, the same mechanism of action responsible for the reduction or relapse symptoms may coincide with catastrophic complications. Research suggests that the pharmacodynamics of Gilenya may be responsible for several side effects with varying degrees of severity. Patients who receive Gilenya treatment may significantly increase their risk of developing severe, life-threatening side effects, the most serious of which is a drastically lowered heart rate. Due to the severity of a reduced heart rate, patients may contact a lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation regarding their potential Gilenya lawsuit.
Gilenya Side Effects
The following is a comprehensive list of the serious side effects associated with Gilenya treatment:
- Slow heart rate
- Increased risk of serious infections
- Macular edema
- Breathing problems
- Liver problems
- Increase in blood pressure
- Chest pain
Slow Heart Rate
Gilenya has several known side effects which include a decrease in heart rate and/or atrioventricular conduction after the first dose. According to an FDA Drug Safety Communication, the agency is evaluating a post-marketing report submitted to their Adverse Events Reporting System (AERS) database regarding a patient who died within 24 hours of taking the first dose of Gilenya (fingolimod). The patient was also treated with metoprolol, a beta blocker, and amlodipine, a calcium channel blocker. Subsequently, the patient had completed 6 hours of monitoring after the first dose without incident, but died less than 24 hours after the first dose. While the exact cause of death has not been established, the FDA is working closely with the manufacturer of Gilenya (Novartis Pharmaceuticals) to evaluate the post-market report of death.
Recent evidence lends weight to the suspected link between Gilenya and decreased heart rates. Similar to that of the previously mentioned individual, are ten other deaths suspected to be related to Gilenya treatment. The European Medicines Agency (EMA), which is now investigating the drug, said it isn’t clear if it caused the deaths. However, the EMA advised doctors to increase their monitoring of patients after the first dose of the medicine. The agency said the risk of a slow heart rate after the first dose of Gilenya was known when it was approved.
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.
Again, if you or a loved one has been injured by Gilenya, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.