FDA Panel Approves Tysabri’s Return

March 2006

Controversial multiple sclerosis (MS) drug Tysabri is returning to the market after an unanimous vote by a Food and Drug Administration (FDA) advisory panel. The drug was recalled last year for causing the deadly brain disease progressive multifocal leukoencephalopathy (PML).

The decision is considered a victory for many MS patients who consider the drug their best or only hope. There is strong evidence that supports claims that Tysabri reduces the rate of MS relapses better than older drugs. However, an estimated one in 1,000 patients using Tysabri may contract PML and increase their risk of death.

To hopefully reduce the number of patients who will develop PML, the FDA will have restrictions on use of the drug:

• Tysabri should not be used with any other MS drugs, even in clinical trials.
• All patients taking Tysabri will be entered into a registry. They and their doctors will have to sign forms acknowledging the risk.
• The drug will be distributed directly to an authorized infusion center where a nurse will go through a checklist with patients to make sure they have no new symptoms that could indicate PML.

The FDA does not have to go along with the advisory panel’s decision, but it is expected that they will. If they do, this would only be the second time a drug has returned to the market after being taken off for safety reasons.

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