TNF blockers boost risk of lymphoma, FDA says

Washington - The Food and Drug Administration (FDA) says an increased risk of lymphoma and other cancers is associated with the use of drugs like Remicade (Centocor) and Humira (Abbott) in children and adolescents, the Wall Street Journal reports.

The agency said a new cancer-related warning will be added to the boxed warning already required on the tumor necrosis factor blockers. The box currently warns of a risk of serious infections that can be fatal.

The drugs, which also include Enbrel (Amgen and Wyeth), Cimzia (UCB) and Simponi (Centocor), are approved for various immune-system diseases including juvenile idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn’s disease and ankylosing spondylitis.

TNF blockers are among the top-selling drugs in the U.S., according to IMS Health, with Enbrel and Remicade having a combined $6.5 billion of U.S. sales in 2008.

Last June, the FDA announced it was conducting a safety review of the TNF blockers after receiving about 30 reports of cancer in children and young adults over a 10-year period.

Read the complete MedWatch 2009 Safety summary, including links to the Information for Healthcare Professionals sheet with recommendations for providers and for patients, and data summaries for the lymphoma, leukemia and psoriasis analyses, at: MedWatch 2009 safety summary