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FDA Reports Recent Case of Brain Infection With Gilenya

Patients with weak immunity most at risk (August 29)

The FDA has alerted the public that a patient in Europe with possible multiple sclerosis (MS) had developed a rare and serious brain infection after taking fingolimod (Gilenya, Novartis). This is the first case of progressive multifocal leukoencephalopathy (PML) reported following the administration of fingolimod to a patient who had not previously received natalizumab (Tysabri, Biogen Idec), a medication for MS that is associated with a higher risk of PML. Fingolimod is used to treat relapsing forms of MS, which affects the brain and spinal cord.

PML is caused by the John Cunningham (JC) virus, which damages myelin, the fatty covering of the brain. PML usually results in death or severe disability and mostly affects those with weakened immune systems.

Patients should not discontinue fingolimod therapy without first consulting their health care professional. Novartis stated that the firm does not believe fingolimod was responsible for PML in this case. The patient was taking other drugs besides fingolimod, Novartis and the FDA explained.

Source: FDA

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