Raptiva Recall Linked To Brain Infections
April 8, 2009
Filed under Uncategorized
The government is warning that taking the psoriasis drug Raptiva could result in serious brain infection and even death.
The Food and Drug Administration cited three confirmed cases, and a possible fourth, of people diagnosed with progressive multifocal leukoencephalopathy (PML) after being treated with Raptiva.
“Three of those patients have died,” the FDA said in a public health advisory. “All four patients were treated with the drug for more than three years…”
Raptiva’s product labeling was revised in October to highlight a boxed warning about 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,” the FDA’s advisory says.
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