FDA Will Conduct A Safety Review Of These TNF Blockers To Investigate This Possible Link
(Posted by Tom Lamb at DrugInjuryWatch.com)
On June 4, 2008 the FDA issued an "Early Communication About an Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers" announcing that the agency has started an investigation into the potential link between certain TNF blockers used to treat Juvenile Idiopathic Arthritis (JIA), Crohn’s disease, or other diseases and the development of lymphoma as well as other cancers in children and young adults.
According to this June 4 article, "FDA Investigates Link Between TNF Blockers and Pediatric Cancer", published online by Medscape Medical News:
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....
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.
After this FDA safety review of Enbrel, Humira, and Remicade is complete, and the agency has reported its findings, we will let you know if there are any resulting recommendations to doctors and patients.
As with all serious side effects from prescription drugs, any adverse events related to the use of Enbrel (etanercept), Humira (adalimumab), or Remicade (infliximab) 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.
[The FDA] has concluded that there is an increased risk of lymphoma and other cancers associated with the use of these drugs in children and adolescents. This new safety information is now being added to the Boxed Warning for these products. FDA has also identified new safety information related to the occurrence of leukemia and new-onset psoriasis in patients treated with TNF blockers. The current prescribing information for TNF blockers does contain a warning for malignancies, but does not specifically mention leukemia....
We will continue to monitor the various serious side effects associated with Enbrel, Humira, Remicade, and these two other tumor necrosis factor (TNF) blockers. (8/5/09)