The agency said the drugs, Enbrel, Humira and Remicade, are widely prescribed to treat autoimmune disorders such as rheumatoid arthritis, juvenile rheumatoid arthritis and Crohn's disease.
Remicade is approved for use in children with Crohn's disease. Enbrel and Humira are approved to treat children with juvenile rheumatoid arthritis, according to the FDA. Enbrel is manufactured by Amgen and Wyeth Pharmaceuticals, Humira is produced by Abbott Laboratories and Remicade is manufactured by Centocor Inc.
The federal agency is investigating about 30 reports of cancer in children submitted between 1998, after the approval of the first TNF blocker, through April. TNF blockers have also been linked to an increased risk of infection.
Though all four TNF blockers are approved for multiple indications, the FDA review is focusing on the first three drugs, namely Enbrel, Humira and Remicade. The drugs work by dampening the immune system, which becomes hyperactive in patients with rheumatoid arthritis.
However, the FDA also clearly stated that the drugs have far more benefits and dramatically improve certain forms of crippling arthritis and almost stop them.
In the wake of ongoing review, FDA advises doctors to weigh the possible association with lymphoma and other cancers against the benefits of treatment when prescribing TNF blockers to children and young adults.
