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FDA Approves Labeling Changes, Boxed Warning for Efalizumab ROCKVILLE, Md -- October 16, 2008 -- The US Food and Drug Administration (FDA) has announced labeling changes, including a Boxed Warning, to efalizumab (Raptiva) to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML). The labeling changes are based on the FDA's post-market surveillance. The FDA is also requiring the submission of a Risk Evaluation and Mitigation Strategy (REMS), which will include a Medication Guide for patients and a timetable for assessment of the REMS. The FDA's Office of Surveillance and Epidemiology has received reports of serious infections leading to hospitalisations, and deaths in some cases, in patients using efalizumab. The now-required Boxed Warning will highlight the risk of bacterial sepsis, viral meningitis, invasive fungal disease, PML, and other opportunistic infections. "As part of FDA's monitoring of the life-cycle of approved products, the agency received reports of serious infections in some patients taking [efalizumab]. These reports led to our decision to highlight these risks in the drugs labeling," said Janet Woodcock, FDA's Center for Drug Evaluation and Research, Rockville, Maryland. "Doctors and other prescribers should carefully evaluate and weigh the risk/benefit profile of [efalizumab] for patients who would be more susceptible to these risks." Health care professionals should monitor patients treated with [efalizumab] for the signs and symptoms of infection, PML, anaemia, thrombocytopenia, or the worsening of their psoriasis or arthritis, and also instruct patients to report any such signs and symptoms to them without delay. Consumers and health care professionals can report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at www.fda.gov/medwatch/report.htm. SOURCE: US Food and Drug Administration E-mail this page to a friend or colleague! To print, use this version