Remicaid

HEALTH CANADA ADVISORY

August 20, 2009

Health Canada issued an advisory concerning the use of Remicade® (infliximab). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

A previous advisory was issued on July 24, 2006, and can be accessed at www.hc-sc.gc.ca.

Some children and young adults with Crohn's disease who were receiving infliximab have developed hepatosplenic T-cell lymphoma, a rare type of cancer that is often fatal. Talk to your doctor if you have any concerns.

Immune system disorders: Some people who take this medication have developed lupus-like syndrome, an autoimmune disease (a condition where the body is attacked by its own immune system). Symptoms of lupus-like syndrome include chest pain, joint pain, difficulty breathing, and a skin rash (usually on the cheeks and arms) that is sensitive to the sun. If you develop these symptoms, contact your doctor as soon as possible.

Infections: This medication can increase the risk of developing an infection, including serious infections such as sepsis, pneumonia, and tuberculosis. Before starting infliximab treatment, your doctor may test to see if you have tuberculosis. If you notice signs of an infection such as fever, chills, pain, swelling, or pus, contact your doctor as soon as possible. This medication should also not be started while you have an active infection. While you are taking infliximab, your doctor will monitor you for signs of infection.

Children: The safety and effectiveness of this medication have not been established for children under 9 years old. It can be used to treat children 9 years and older who have moderate-to-severe Crohn's disease. The safety and effectiveness of this medication for treating other conditions in children 9 years and older have not been established.