The FDA has slapped a "black box" warning onto Genentech's psoriasis treatment Raptiva. The new labeling will highlight the risk of potentially fatal infections -- including PML, or progressive multifocal leukoencephalopathy. And the agency is requiring Genentech to come up with a risk-management plan for the drug and a medication guide for patients who use it.
Tuesday, the company announced the death of a 70-year-old man who had developed PML after four years on Raptiva. It's the same case that Genentech first announced two weeks ago. Meanwhile, the FDA's surveillance office has been receiving reports of serious infections that in some cases led to death. Among the problems the new warning will highlight: bacterial sepsis, viral meningitis, PML, and invasive fungal disease. The label will also point out animal research that indicates repeated pediatric use of Raptiva might increase the risk of permanent suppression of the immune system.
There's no proof that Raptiva actually caused any of these infections. But the FDA and Genentech want to make sure patients and doctors are on the lookout for potential symptoms, so that any illnesses can be caught early on.