To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves Labeling Changes, Boxed Warning for Efalizumab URL: http://www.pslgroup.com/dg/22EEC6.htm Doctor's Guide October 16, 2008
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 --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.