This article is more than 5 years old. Information may no longer be current.

FDA strengthens warnings for TNF blockers

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

Yesterday, the FDA announced that prescribing information for TNF blockers must include information about the increased risk for cancer in children and adolescents assigned to these drugs.

Drugs in this class include infliximab (Remicade, Centocor), etanercept (Enbrel, Immunex), adalimumab (Humira, Abbott), certolizumab pegol (Cimzia, UCB) and golimumab (Simponi, Centocor Ortho Biotech).

The FDA began looking for a possible link between TNF blockers and cancer in June 2008. Analysis showed an increased risk of cancer in children and adolescents after an average of 30 months of treatment with TNF blockers. About half the cancers were lymphomas.

TNF blockers are used to treat juvenile rheumatoid arthritis, inflammatory bowel disorder, Crohn’s disease and other inflammatory diseases by targeting and neutralizing the protein tumor necrosis factor-alpha. The presence of chronic inflammatory diseases causes the body to overproduce the protein, which can cause inflammation and damage to bones, cartilage and tissue.

The agency also announced it is working with manufacturers to find new ways to better define the risk of cancer in children and adolescents assigned to these drugs.