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October 22, 2013

FDA Investigates Brain Infection-Gilenya Case

Quoted from http://www.webmd.com/multiple-sclerosis/news/20131018/fda-investigate-gilenya

FDA Investigates Brain Infection-Gilenya Case

By Kathleen Doheny
WebMD Health News Reviewed by Michael W. Smith, MD

Oct. 18, 2013 -- The FDA is continuing to investigate a possible link between the multiple sclerosis drug Gilenya (fingolimod) and a case of a rare brain infection in a European patient.

The patient took the drug for nearly 8 months before being diagnosed with the brain infection. The FDA issued an alert at the end of August to inform the public of its investigation.

The brain infection, sometimes fatal, is called PML (progressive multifocal leukoencephalopathy). The European case is the first reported in a patient who has not previously taken the drug Tysabri (natalizumab). Tysabri is already known to be linked with a higher risk for PML.

The maker of Gilenya, Novartis, issued a statement saying it had reviewed all available evidence and that the case of PML in Europe is unlikely to be linked to the drug.

[Article continues at original source]

Posted at 07:54 AM in Gilenya |

Tags: drug injury, FDA warning, fingolimod, Gilenya, multiple sclerosis drug, Novartis, PML, progressive multifocal leukoencephalopathy, side effects

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