Quality & Patient Safety

Psoriasis drug under investigation by FDA

Patient Safety Monitor: Global Edition, March 3, 2009

The U.S. Food and Drug Administration (FDA) issued a public health advisory for patients using the drug Raptiva (efalizumab), after three confirmed and one possible report of multifocal leukoencephalopathy (PML), a rare brain infection. Three patients have died as a result from this brain infection, and all four patients had taken Raptiva for more than three years, according to a news release by the FDA.

In October 2008, the FDA asked Genentech, product labeling company for Raptiva, to highlight in a boxed warning the risks of life-threatening infections. The FDA also requested Genentech to include a medication guide to educate patients about the drug's risks.

According to the FDA, healthcare professionals have been asked to monitor patients who are on Raptiva, as well as those who have discontinued using it, for any signs or symptoms of neurological disease.

Healthcare professionals and patients affected by the drug are urged to contact the FDA's MedWatch Adverse Event Reporting program online, by regular mail, fax, or phone.

To read more, click here.

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