The EMEA announced, in a press-release, on the 23 October that there are now 23 post-marketing natalizumab-related PML cases:
“Review of benefits and risks for Tysabri started -The Committee started a review of the benefits and risks of Tysabri, in view of reports of 23 cases of progressive multifocal leukoencephalopathy (PML) worldwide since Tysabri has been on the market. This review is initiated to discuss any additional measures necessary to ensure the safe use of Tysabri and how to balance the risks to the patients against the benefits of the treatment. Tysabri is indicated for patients suffering from highly active relapsing remitting multiple sclerosis with high disease activity despite treatment with a beta-interferon and for patients with rapidly evolving severe relapsing-remitting multiple sclerosis.” EMEA
You need to more vigilant than ever regarding possible symptoms of PML if you have been on Natalizumab (Tysabri) more than 12 months.