Tysabri Pharmaceutical Injury Lawyers

Tysabri had been trumpeted as a major advance in the treatment of multiple sclerosis, winning accelerated government approval that put the drug on the market in November 2004.

However, Tysabri (nataluzimab) was suddenly suspended from the market after it was linked to an untreatable brain disease among two patients, one of whom died. A month later, another patient using Tysabri died from the rare disease.

However, just three months later, Tysabri (nataluzimab) sales were suddenly suspended after it was linked to a rare and untreatable brain disease among two patients involved in Tysabri clinical studies. One of the patients died.

The manufacturers of Tysabri, Biogen Idec Inc. and Elan Corp., suspended Tysabri from the market after consultation with the U.S. Food and Drug Administration, which had approved sales of Tysabri (formerly known as Antegren in clinical studies.)

On Feb. 28, 2005, the day Tysabri was suspended from the market, the FDA issued a public health advisory on its potential danger. Patients taking Tysabri were told to contact their doctors to discuss alternative treatment while the two cases of severe side effects were being investigated.

Kline & Specter is currently representing people across the United States involving a variety of suspect medications. The firm does not balk at taking on major corporations, as evidenced in our record of representing victims of bad products. Visit our main website and read about our Major Victories and examine our Mass Tort Department which spearheads drug lawsuits. Learn about our Doctor/Lawyer Team that offers unsurpassed expertise for such litigation

The two initial Tysabri patients who contracted PML had been part of a study in which they took Tysabri (formerly known as Antegren) along with an older Biogen drug called Avonex, leading to speculation that the combination of the two drugs may have been the culprit. However, in the most recent case, the patient who died of PML had been taking Tysabri alone.

While Biogen and Elan had held out hope of returning Tysabri to the market, news of the second PML death in a patient who had not also used Avonex prompted some analysts to predict the demise of Tysabri.

The two patients who contracted PML had been part of a two-year clinical study in which they took Tysabri (formerly known as Antegren) along with another Biogen drug called Avonex, which had been on the market since 1996 and had never been associated with PML.

About 3,000 patients took Tysabri in clinical trials, with only 1,000 followed for more than two years. According to the FDA, an additional 5,000 multiple sclerosis patients began using Tysabri, which is administered intravenously, after its approval in November 2004.

The FDA concluded: “Although the relationship between Tysabri and PML is not known at this time, because of the serious and often fatal nature of PML, FDA concurred with the company that the drug be voluntarily withdrawn from marketing and that the use of Tysabri in clinical trials be suspended until more is known.”

There have been critics of the FDA’s fast-track approval of Tysabri. Lawrence Steinman, chief of immunology at Stanford University, told The New York Times that the FDA approved Tysabri based on limited data and that since Tysabri works by suppressing the immune system, the risk of serious infections such as PML was "unfortunately logical."

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If you or a loved one has been harmed by Tysabri, you need a law firm with the resources and the experience to bring you justice. Please call or e-mail the Tysabri attorneys at Kline & Specter. We'll evaluate your claim for free and we don't get paid unless you do. Our expertise will help you get the compensation you deserve.

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This page was last updated on January 31, 2007.