Safety Update on TNF Blockers and Risk of Cancer in Children and Young Adults

Safety Update on TNF Blockers and Risk of Cancer in Children and Young Adults

2009-137

Health Canada is informing health care professionals and Canadians that it is working with manufacturers to further strengthen product labelling for the class of drugs known as tumour necrosis factor (TNF) blockers with respect to an increased risk of cancer in children and young adults.

This communication comes in light of similar labelling updates undertaken by the U.S. FDA following their review, which concluded that there is an increased risk of lymphoma and other cancers associated with the use of TNF blocker drugs in children and adolescents. Health Canada has also been reviewing this issue and is currently working with the manufacturers to strengthen existing warnings in the prescribing information for these drugs.

TNF blockers are used to treat patients with chronic inflammatory diseases including juvenile idiopathic arthritis (JIA), rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn's disease, and ankylosing spondylitis (a type of arthritis). They suppress the activity of tumour necrosis factor, a protein that, when overproduced in the body, can cause inflammation and damage to bones, cartilage and tissue, and lead to immune system-related diseases. There are currently five prescription TNF blockers authorized in Canada : Enbrel (etancercept) , Remicade (infliximab), Humira (adalimumab), Simponi (golimumab), and Cimzia (certolizumab pegol).

Currently the labels for all TNF blockers include warnings and precautions on the risk of lymphomas and other cancers. The labels will be updated to highlight the risk of specific cancers, particularly in the younger patient groups. As well, the label updates will include other new safety information based on reviews conducted by Health Canada , including the risk of new-onset psoriasis in patients treated with TNF blockers. Health Canada will inform health care professionals and Canadians again once these updates are complete.

The role of TNF blockers in the development of cancer is not known. Health Canada has communicated in the past on the risk of the development of certain types of cancers, including lymphoma, associated with the use of these drugs.

Health Canada recommends that patients should not stop taking their TNF blocker without first speaking to their doctor. Patients should contact their health care professional if they have any concerns about any medicines they are taking.

You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

Report online at the MedEffect ™ Canada Web site

Call toll-free at 1-866-234-2345

Complete a Canada Vigilance Reporting Form and either: Fax toll-free to 1-866-678-6789

Mail to: Canada Vigilance Program Health CanadaAL 0701C Ottawa , ON K1A 0K9

Media Enquiries:Health Canada(613) 957-2983

Public Enquiries:(613) 957-29911-866-225-0709