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FDA: First Report of Patient on Gilenya Developing Rare Brain Infection

Jan 1, 2013

A person in Europe who has been taking the prescription drug Gilenya has developed a rare brain infection known as progressive multifocal leukoencephalopathy or PML.

A person in Europe who has been taking the prescription drug Gilenya has developed a rare brain infection known as progressive multifocal leukoencephalopathy or PML.

We’ve reported on the risks associated with taking Tysabri in the past, namely the risk of developing life-threatening PML. The risk of PML has also been linked to use of Avonex and Raptiva, which even garnered its own Black Box warning from federal health regulators back in 2008.

Our reports show that PML can have lethal consequences, and symptoms of the rare brain infection include vision loss, paralysis, a deteriorating mental state, ataxia, comas, and seizures.

The FDA warns that despite the diagnosis of a patient with PML while only taking Gilenya, the agency says that patients should not stop taking the drug on their own and should consult with their physician first. The agency adds that it is now contacting the maker of Gilenya, Novartis, to gather more information about a potential risk facing other patients taking Gilenya who had not previously taken Tysabri.

Regulators say that the European who developed PML had been taking Gilenya for eight months prior to being diagnosed with the brain infection. According to the agency’s warning statement this week, here are other details regarding drugs the patient was taking or receiving:

Interferon beta-1a and azathioprine for one month before initiating Gilenya treatment; and multiple courses of intravenous corticosteroids for several months before and during Gilenya treatment.


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