FDA investigating fingolimod after report of rare brain infection

In a Drug Safety Communication, FDA has reported that a patient in Europe being treated for multiple sclerosis and who had no history of using natalizumab (Tysabri) developed progressive multifocal leukoencephalopathy (PML) while taking fingolimod (Gilenya).

PML is a rare and serious brain infection caused by the John Cunningham (JC) virus that damages the fatty covering of the brain called myelin. Myelin is essential for the proper functioning of nerves in the white matter of the brain. PML usually causes death or severe disability. The JC virus is a common virus that is harmless in most people but can cause PML in people who have weakened immune systems, according to FDA.

FDA is advising that patients should not stop taking Gilenya without first discussing any questions or concerns with their healthcare professionals.

“We are providing this alert while we continue to investigate the PML case, and we are working with Gilenya’s manufacturer, Novartis, to obtain and review all available information about this occurrence. We will communicate our final conclusions and recommendations after our evaluation is complete,” FDA stated.

The recently released report by FDA . . . should not lead clinicians or consumers to automatically conclude that there is a link until further investigation is performed by FDA,” Formulary advisor Abimbola Farinde, PharmD, MS, clinical staff pharmacist at Clear Lake Regional Medical Center, Webster, Texas. “The existing reports of risk factors that have been identified for PML with use of Tysabri, a monoclonal antibody and selective adhesion-molecule inhibitor, was and still remains a cause for concern when this information was initially released a few years ago.”

“This new report on Gilenya will also be handled in the same manner, and clinicians should continue to closely monitor patients on Gilenya for any possible side effects until additional information and recommendations are released,” Dr Farinde said.

Gilenya was approved for use in the United States in September 2010. Novartis reports that approximately 71,000 patients worldwide have been treated with Gilenya.