Washington – A multiple sclerosis drug pulled from the market last year because of a rare but life-threatening side effect will return under a restricted distribution program, health officials said Monday.
The Food and Drug Administration said it will let Biogen Idec Inc. and Elan Corp. PLC resume selling Tysabri under a requirement that doctors, pharmacies and patients register with a program designed to ensure the safe use of the drug. It could be available as soon as July.
Tysabri received FDA approval in November 2004. Biogen Idec, its Cambridge, Mass.- based manufacturer, voluntarily withdrew it in February 2005 after two patients in clinical trials died of a rare brain infection called progressive multifocal leukoencephalopathy, or PML.
Only one other prescription drug, the irritable bowel treatment Lotronex, has ever returned to the market after being pulled because of side effects.
The FDA said Tysabri is to be used alone in patients who did not respond “adequately” to – or cannot tolerate – other MS medications.
Previously, some doctors prescribed it with Avonex, also made by Biogen Idec.
Researchers have estimated that as many as one in every 1,000 Tysabri users might fall prey to a virus that causes PML. Patients supported the return of Tysabri, despite its risks.
“The benefits, No. 1, are worth it. No. 2, I am not afraid of dying, I am afraid of … being a burden to my family,” said Barbara Crooks, 48, a retired magnetic resonance imaging technologist in Irwin, Pa.
The once-a-month intravenous drug is meant to treat patients with relapsing MS to reduce flare-ups, which can complicate walking and seeing.
