The agency is adding labeling changes, including a boxed warning, to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy, or PML, that may develop when using the drug, which is approved to treat moderate to severe plaque psoriasis. The FDA is also requiring Genentech to formulate a risk mitigation strategy and med guide for patients.

The moves comes two weeks after Genentech sent a letter to healthcare professionals about the case of a 70-year-old man who was being treated for psoriasis for more than four years with its med, and developed PML. The FDA’s Office of Surveillance and Epidemiology has received reports of serious infections leading to hospitalizations and, in some cases, deaths (read here).

The Boxed Warning will highlight the risk of bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy and other opportunistic infections. The label will also now include data from juvenile animal studies in mice (age equivalent to kids between 1 and 14 years old) indicating a potential risk for permanent suppression of the immune system with repeat administration of Raptiva in this age group. Raptiva is not approved for children under 18 years of age.