Has someone you love died after using Gilenya?

The multiple sclerosis drug, Gilenya, was approved for us in the US in 2010, and in May of 2012, the FDA has updated its warnings about the drug due to several deaths associated with the use of the drug, including the death of one patient who died soon after taking the first dose.  It is now being recommended that “high-risk” patients be monitored with an ECG overnight after taking the first dose of the medication.

Gilenya, the brand name for the drug fingolimod, is used to treat relapsing-remitting MS, which is one of four courses of the disease. A patient may be diagnosed with one of the four courses of MS, and may possible progress into a different course, or remain in the same course. Multiple sclerosis is a debilitating neurological disease that attacks the central nervous system.  The central nervous system consists of the brain, spinal cord, and optic nerves.  Symptoms of MS vary for each patient, as does the progression of the disease and its debilitation.  In a patient with MS, the body’s own defense system attacks myelin, which is the fatty substance that surrounds and protects the nerve fibers of the central nervous system.  Because the body is attacking itself, MS is believed to be a type of autoimmune disease.  When the attacks on the myelin occur, it can cause a variety of symptoms in the patient, nerve impulses that travel to and from the brain and spinal cord are distorted or interrupted, which affects individuals differently.  Many people with MS cope with the disease and continue to live productive lives.

Deaths Associated with Gilenya

The makers of Gilenya, Novartis, announced the death of a patient last November.  The patient had died shortly after taking the first dose.  Worldwide, there have been 11 deaths of patients who have taken the drug.  According to Novartis, six deaths remain unexplained, three patients died from heart attacks, and one died from disruption of heart rhythm.  Novartis is not stating that Gilenya caused the deaths, or if it had any role in the deaths at all, but they are now recommending that doctors monitor patients for at least six hours after the initial dose of Gilenya to look for any unusual heart activity.

Other Serious Side Effects Associated with Gilenya

There are approximately 30,000 patients worldwide who take Gilenya.  Eleven people who have taken Gilenya have died since it was approved as a treatment for MS.  There are other severe side effects that have also been associated with the use of Gilenya.  Some patients have reported the following severe side effects:

  • Infections
  • Macular edema (swelling of part of the eye)
  • Respiratory effects
  • Hepatic (liver) effects
  • Bradyarrhythmia and atrioventricular blocks, which are conditions that occur when electrical impulses between the upper and lower chambers of the heart are interrupted

Do you Have a Case?

If you have taken the drug Gilenya and are suffering from debilitating side effects, or if you have lost a loved one after they have taken Gilenya, you may have a case against the manufacturer of the drug.  It is important that you contact us immediately to determine the best course of action for your individual case.