USA. Centocor, Inc1. has issued a 'Dear Health-care Professional' letter advising that a warning of malignancies has been added to the US infliximab (Remicade) label. Following the evaluation of safety data on tumour necrosis factor (TNF)- antagonists at a US FDA Arthritis Advisory Committee meeting in 2003, a malignancy warning has been added to the labels of all TNF-antagonists.
The new warning, and the updated Adverse Reactions section of the infliximab (Remicade) prescribing information advise that the incidence of lymphoma is approximately six-fold higher in the combined Crohn's disease/rheumatoid arthritis population from clinical trials of infliximab (Remicade) than in a sex-, age- and race-matched general population. However, they also state that the risk of developing lymphoma has been reported to be up to several-fold higher in the Crohn's disease/rheumatoid arthritis population. The potential role of TNF-antagonist therapy in malignancy development is not known. More recently, Schering Canada2, in consultation with Health Canada, issued a letter to health-care professionals with similar information, regarding the new warnings added to the infliximab product monograph in Canada. As in the USA, the above information is already included in the Canadian product monographs for TNF-blockers.
1. 'Dear Health-care Professional' letter from Centocor Inc, October 2004. Available on the Internet at www.fda.gov
2. 'Dear Health-care Professional' letter from Schering Canada Inc, 29 November 2004. Available on the Internet at www.hc-sc.gc.ca