REMICADE SAFETY ALERT

REMICADE® (infliximab) is a Biological Response Modifier that is directed against the cytokine tumour necrosis factor-α(TNFα). It is indicated for the treatment of adults with rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriatic arthritis, and chronic plaque psoriasis. Six (6) post-marketing cases of a rare type of lymphoma called hepatosplenic T-cell lymphoma (HSTCL) have been reported in pediatric and young adult patients taking REMICADE® for Crohn's disease. Five of the six cases (all U.S.) resulted in death. All cases reported concomitant or past use of other immunosuppressive agents, including azathioprine or 6-mercaptopurine. Although lymphomas have been reported in Canada in patients receiving REMICADE® for Crohn?s disease and other indications, there have been no reports of HSTCL. REMICADE® is not authorized for pediatric use in Canada.