FDA Investigates Link Between TNF Blockers and Pediatric Cancer

Yael Waknine

Disclosures

June 04, 2008

June 4, 2008 — An investigation has been launched into the potential link between tumor necrosis factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults, the US Food and Drug Administration (FDA) announced today in an early communication.

Approximately 30 cases of cancer have been reported during a 10-year period extending through April 2008, occurring in pediatric patients receiving TNF blockers with other immunosuppressive therapies to treat juvenile idiopathic arthritis, Crohn's disease, or other conditions. About half of the cancers were Hodgkin's and non-Hodgkin's lymphomas; leukemia, melanoma, and solid organ malignancies were also reported, the agency said.

TNF blockers currently approved for pediatric use include etanercept (Enbrel, Immunex Corp, marketed by Amgen and Wyeth Pharmaceuticals), adalimumab (Humira, Abbott Laboratories), and infliximab (Remicade, Centocor, Inc). Makers of these products have been asked to supply the FDA with information regarding cancer cases in children receiving treatment.

In addition, a 10-year study will be conducted to assess the long-term risks of certolizumab pegol (Cimzia, UCB Inc), a TNF blocker recently approved to treat Crohn's disease in adults. Cancers often take a long time to develop and may not be detected in short-term studies, the FDA said.

As part of the 6-month review process, the agency has also contacted medical experts to assess the potential link between TNF blockers and cancer and also whether some children may be at particular risk for malignancy.

Once the review is complete, the agency will communicate its findings and any resulting recommendations to the public. In the interim, healthcare professionals are advised to weigh the potential association with lymphoma and other cancers against the benefits of treatment when prescribing TNF blockers for children and young adults.

"At the current time, the FDA believes that the potential benefits of the use of TNF blockers outweigh the potential risks in certain children and young adults," the agency noted.

Adverse events related to the use of etanercept, adalimumab, infliximab, or certolizumab pegol should be reported 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, MD 20852-9787.

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