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PML Confirmed in 2 More Tysabri Patients

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Tysabri , pulled from the market over safety concerns in 2005 but returned a year later, has been linked to two more cases of the fatal brain infection progressive multifocal leukoencephalopathy, or PML. The most disturbing aspect of these latest PML cases, however, is that both patients had been taking Tysabri as monotherapy – with no other drugs. It had been theorized that patients contracting PML had done so because of exposure to multiple medications and that monotherapy with Tysabri was less risky.

In 2005, Biogen Idec and Elan voluntary suspended sales of Tysabri. The Food & Drug Administration (FDA) said the suspension was the result of reports from Biogen Idec of one confirmed, fatal case and one additional case of PML in patients receiving Tysabri for MS. Both patients were enrolled in a long-term Tysabri clinical trial and had been taking Tysabri for more than two years. The FDA later re-approved Tysabri in 2006, after deciding that benefits in slowing MS relapses outweighed Tysabri risks.

In 2005, the law firm Parker Waichman LLP was retained by the estate of Anita Smith, a patient who died from a confirmed case of PML while taking Tysabri. Smith died in February 2005, just days before Tysabri was withdrawn from the market. In its 2005 Annual Report, Elan Inc. informed shareholders that it had entered into settlement talks with the lawyers representing Anita Smith’s estate. When contacted, Jerry Parker, the managing partner of Parker Waichman LLP said the Anita Smith Tysabri case had been resolved, but that the case was confidential.

According to Elan and Biogen Idec, the makers of Tysabri, two European patients have developed the same disease. At this time, one is ambulatory and the other is hospitalized. One patient had been taking Tysabri for 14 months and the other for 17.

PML attacks the brain and central nervous system and is usually fatal. Symptoms include vision problems, loss of coordination, and memory loss. Patients who survive the disease are often permanently disabled.

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