U.S. health regulators warned today that the psoriasis drug Raptiva has been associated with three fatal cases of a brain infection known as progressive multifocal leukoencephalopathy, or PML. The Food & Drug Administration (FDA) also said it was aware of a possible fourth Raptiva patient who may have developed the deadly brain disease.
Raptiva is an injectable drug that was approved by the FDA in 2003 to treat moderate to severe plaque psoriasis. Raptiva works by blocking the activation of certain immune cells called T cells, and the migration of those cells into the skin. However, by suppressing the body’s natural defense system, it can also increase the risk of serious infections and malignancies in patients.
In October 2008, the product labeling for Raptiva was revised to highlight in a boxed warning the risks of life-threatening infections, including PML. At that time, the FDA directed Genentech, the manufacturer, to develop a risk evaluation and mitigation strategy (REMS) to include a medication guide to educate patients about the drug’s risks.
PML attacks the brain and central nervous system and is usually fatal. It is caused by a polyomavirus, called the JC virus. The JC virus is often acquired during childhood. Most adults have been infected with the JC virus but do not develop PML. Symptoms include vision problems, loss of coordination, and memory loss. Patients who survive the disease are often permanently disabled.
According to an FDA health alert issued today, all four Raptiva patients who developed PML had been treated drug for more than three years. None of the patients were receiving other treatments that suppress the immune system, the agency said.
In the alert, the FDA strongly advised health care professionals to carefully monitor patients on Raptiva, as well as those who have discontinued the drug, for any signs or symptoms of neurologic disease. Healthcare professionals should also periodically reassess the benefits of continued treatment, the agency said. Finally, patients should be aware of the symptoms of PML and contact their health care professionals immediately if they experience any such symptoms.
The FDA said it is currently reviewing the latest information regarding Raptiva and PML. It is taking action to ensure that the risks of Raptiva do not outweigh its benefits.
Meanwhile, regulators in Europe have already decided that the benefits of Raptiva are not worth its risks. According to Bloomberg.com, the European Medicines Agency recently said sales of the drug should be suspended because of its association with PML.
“The benefits of Raptiva no longer outweigh its risks, because of safety concerns,” European regulators said today in an e-mailed statement. “Prescribers should not issue any new prescriptions for Raptiva and should review the treatment of patients currently receiving the medicine to assess the most appropriate alternatives.”
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