FDA Updates Warnings for TNF Blockers and Cancer Risk

Emma Hitt

Disclosures

August 04, 2009

August 4, 2009 — The US Food and Drug Administration (FDA) is requiring stronger warnings regarding the risk for cancer associated with tumor necrosis factor (TNF) blockers.

An alert sent today from MedWatch, the FDA's safety information and adverse event reporting program, states that the warnings will include an updated boxed warning and highlight the increased risk for cancer in children and adolescents who take TNF blockers for the treatment of juvenile rheumatoid arthritis, Crohn's disease, and other inflammatory diseases.

Today's action represents the completion of an investigation announced by the FDA in June 2008. On average, an increased risk for cancer was reported after 30 months of treatment with TNF blockers. Lymphoma was the most common cancer type, accounting for about half of all cancers.

"The current prescribing information for TNF blockers does contain a warning for malignancies, but does not specifically mention leukemia," the FDA states.

In addition to the updated boxed warning, the FDA is requiring an update to the Warning section of the prescribing information describing reported cases of leukemia in adults, adolescents, and children, as well as additional information on malignancies in children and adolescents. Psoriasis is also associated with the use of TNF blockers, and this information will be incorporated into updated prescribing information in the Adverse Events section. The revised medication guide given to patients will include this new safety information.

The TNF blockers include infliximab (Remicade, Centocor Ortho Biotech Inc), etanercept (Enbrel, Amgen and Wyeth), adalimumab (Humira, Abbott), certolizumab pegol (Cimzia, UCB), and golimumab (Simponi, Centocor Ortho Biotech Inc and Schering-Plough Corporation).

More information is available on the MedWatch Web site.

Adverse events related to use of TNF blockers should be communicated to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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