Market Name: Tysabri

Generic Name: Natalizumab

Tysabri, a treatment for some forms of multiple sclerosis, can increase the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Tysabri is only available through a restricted distribution program.

A black box warning related to the risk of PML was added to Tysabri’s labeling in June of 2006.

Black Box Warning Date: June 2006

FDA Link: Tysabri