The U.S. Food and Drug Administration (FDA) has warned the public that the multiple sclerosis (MS) drug fingolimod—sold under the brand name Gilenya—might cause a life-threatening brain condition called progressive multifocal leukoencephalopathy (PML). PML might occur even in patients who have not taken natalizumab (Tysabri), another MS drug known for causing PML.
What Is Gilenya? When Is It Prescribed?
Made and sold by the Swiss pharmaceutical company Novartis AG, fingolimod was first synthesized in a Japanese laboratory in 1992 from an immunosuppressive product called Myriocin. According to the Gilenya drug label, medical science does not know how the drug works, but it is believed that Gilenya prevents white blood cells from migrating into the central nervous system. The FDA approved Gilenya in September 2010; doctors can prescribe it in oral capsules.
Gilenya Might Cause Life-Threatening Brain Infections
On August 29, 2013, the FDA issued a Gilenya warning in the form of a drug safety communication. The agency alerted the public that a European MS patient had developed PML while taking Gilenya. It was the first known case of PML in a Gilenya patient who had not also taken Tysabri, another MS drug suspecting of causing PML.
PML is a rare disease caused by the John Cunningham virus, which is common and almost always harmless in humans but can attack those with compromised immune systems, such as those of people on immunosuppressants like Gilenya. PML destroys the fatty covering of the brain called myelin, thereby impairing transmission of electrical signals in the brain. Symptoms of this disease include:
- impaired speech
- vision loss
- cognitive deterioration
An MRI can detect PML, but other than blood plasma transfusions to cycle the drug out of the body no effective treatment exists. Patients usually die within four months of being diagnosed.
According to the FDA, the European patient who developed PML had been on Gilenya for eight months. It is unclear whether he or she survived. The FDA is not advising Gilenya users to quit the drug without talking to their doctors first.
RLG’s Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers of the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Gilenya lawsuit on your behalf if necessary.
If you have taken Gilenya and believe it harmed you, contact RLG today.