The Food and Drug Administration (FDA) has announced that long-term use of natalizumab (Tysabri) may increase the risk of progressive multifocal leukoencephalopathy (PML)—even if the patient's drug regimen includes no other immunomodulatory therapies. The announcement comes after the drug's manufacturer reported new cases of PML in two European patients with multiple sclerosis (MS). Both patients received natalizumab as monotherapy for longer than 1 year.
   Although previous cases of PML have occurred in MS patients who took natalizumab with other immunomodulators, FDA officials continue to believe that monotherapy with natalizumab has a lower risk of PML than combination therapy. Officials are working with the drug maker to amend natalizumab's label to include the risk of PML during monotherapy. PML usually is fatal.
   In the United States, natalizumab is available only for patients with relapsing MS or Crohn's disease who are enrolled in a special risk-reduction prescribing program known as TOUCH. No new cases of PML have been reported in the United States.

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