November 19, 2009
FDA Safety Communication on TNF Blockers
On August 4th, the FDA issued information for healthcare professionals via their website regarding the entire anti-TNF class to communicate important safety information about pediatric malignancies, new onset and exacerbations of psoriasis (including pustular psoriasis and palmoplantar psoriasis), and potential risk of leukemia. This information is available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm175803.htm.
Centocor Ortho Biotech Inc., in collaboration with the U.S. Food & Drug Administration (FDA), will update the physician labeling, Medication Guides and Risk Evaluation and Mitigation Strategies (REMS) and associated communication plans for REMICADE® (infliximab) and SIMPONI™ (golimumab) with revised safety information about pediatric malignancies, new onset and exacerbations of psoriasis, and potential risk of leukemia as reported in patients treated with TNF blockers.
Please see the REMICADE® (infliximab) prescribing information and Medication Guide and the SIMPONI™ (golimumab) prescribing information and Medication Guide on MEDVERSATION™. Note that the prescribing information for these products and other content on MEDVERSATION™ related to these changes will be updated in the near future.