FDA Checking for Cancer-TNF Drug Link
Cancers Reported in Some Kids Taking Remicade, Enbrel, Humira, and Cimzia
June 4, 2008 -- The FDA is investigating whether cancers in about 30 children and young adults are linked to the use of Remicade, Enbrel, Humira, or Cimzia to treat childhood arthritis, Crohn's, or other diseases.
The cancers occurred over a 10-year period beginning in 1998.
Remicade is approved for use in children to treat Crohn's disease. Enbrel and Humira are approved for use in children to treat juvenile idiopathic arthritis, formerly known as juvenile rheumatoid arthritis.
The drugs block a molecule, called tumor necrosis factor or TNF, thereby switching off immune responses that make joints and tissues swell and redden. The drugs help calm overactive TNF in patients with certain types of arthritis, Crohn's disease, severe psoriasis, and other autoimmune diseases. But TNF is also part of the body's defense against cancer.
On their labels, all of the drugs list cancer -- particularly lymphoma, a cancer of white blood cells -- among their serious possible side effects. The labels warn patients and their parents that the drugs lower the body's ability to fight off infections.
The FDA has asked the makers of the drugs approved for children to provide information about all cases of cancer reported in children taking the drugs. The maker of Cimzia is required to conduct a long-term safety study of the product, which will begin in 2009.
"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 having one of the diseases for which the TNF blockers are approved to treat," the FDA says in an "early communication" statement. "Until the evaluation is completed, healthcare providers, parents, and caregivers should be aware of the possible risk of lymphoma and other cancers in children and young adults when deciding how to best treat these patients."
During its investigation, which is expected to take six months, the FDA says it will consult medical experts to assess the potential link between these drugs and cancer. The investigation will also look at whether there are certain children with juvenile arthritis or Crohn's disease who may be at particular risk of developing cancer.
WebMD offered the manufacturers of each of the drugs the opportunity to comment on the FDA investigation.
"The full body of Humira safety data was reviewed when it was first approved for children to treat juvenile idiopathic arthritis," Abbott spokeswoman Raquel Powers tells WebMD. "There have been no cases of lymphoma in children in clinical trials or in postmarketing surveillance of Humira."
Embrel, marketed by Wyeth and Amgen, was approved for treating juvenile idiopathic arthritis in 1999, notes Amgen spokeswoman Sonia Fiorenza.
"Amgen and Wyeth support the ongoing FDA review," Fiorenza tells WebMD. "It is noted in the FDA communication that the benefits of Enbrel outweigh the risks. Patients, doctors, and caregivers should weigh the benefits and risks of Enbrel, but the benefit for the juvenile idiopathic arthritis population has been substantial."
Remicade maker Centocor and Cimzia maker Nektar did not respond to WebMD's request for comment by publication time.
Remicade, Enbrel, Humira, and Cimzia are each approved to treat one or more of a number of immune system diseases including juvenile idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn's disease, and ankylosing spondylitis.