
The temporary withdrawal of natalizumab (Tysabri) from the market in February 2005 in response to 3 cases of progressive multifocal leukoencephalopathy (PML) among clinical trial participants was a wake-up call for the neurology community about the risks of therapies for multiple sclerosis (MS). Although natalizumab returned to the market under a restricted distribution program in June 2006, the impact of the withdrawal remains evident in the more guarded optimism now being expressed by clinicians and researchers about the agent and about other immunosuppressive therapies for relapsing- remitting MS (RRMS) in the absence of longterm safety data.