updated 6/2/2005 12:47:16 PM ET 2005-06-02T16:47:16

The maker of a multiple sclerosis drug that was pulled from the market said a fourth patient may have contracted a potentially fatal disease after treatment, The Boston Globe reported Thursday.

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Biogen Idec Inc. told the Food and Drug Administration about the possible fourth case in a filing obtained by the Globe under the Freedom of Information Act.

Biogen and Elan withdrew the drug, Tysabri, in February and halted ongoing studies because of fears that the drug may be linked to the rare brain disease, called progressive multifocal leukoencephalopathy, or PML.

Two MS patients using Tysabri contracted the disease; one died. A third patient who had been taking Tysabri for Crohn’s, a bowel disease, later was confirmed to have died from PML.

The possible fourth PML patient is a 48-year-old woman who was taking Tysabri and Avonex, another MS drug sold by Biogen.

Fourth patient still alive
Biogen spokeswoman Amy Brockelman told The Associated Press on Thursday that the fourth patient is alive, but she declined to offer further details on the case. She said Biogen was reviewing all suspected cases as part of a safety evaluation and hoped to finish the work by summer’s end.

Elan spokeswoman Emer Reynolds declined to comment on the Globe report.

“We don’t comment on rumors or individual cases going through the safety evaluation process,” she said in Dublin on Thursday.

FDA spokeswoman Lenore Gelb said the agency is “in communications with (Biogen) on this case, as well as on the ongoing safety review.”

The FDA, after reviewing one year of data from planned two-year trials, in November approved Tysabri for sale to the 350,000 American sufferers of multiple sclerosis, a debilitating and incurable disease that can cause sudden partial paralysis. The drug has been shown effective in reducing relapses among MS patients.

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