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FDA Starts Safety Review of Autoimmune Disorder Drugs
Reports of increased cancer risk among young users of TNF blockers prompts action
By Amanda Gardner
HealthDay Reporter
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WEDNESDAY, June 4 (HealthDay News) -- U.S. health officials have started a safety review of a class of drugs known as tumor necrosis factor (TNF) blockers, which are widely prescribed to treat autoimmune disorders such as rheumatoid arthritis, juvenile rheumatoid arthritis and Crohn's disease.
The announcement did not come as a surprise, as experts have long debated the risk-benefit profile of the drugs without coming to any consensus.
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Among the chief concerns being investigated by the U.S. Food and Drug Administration are whether the drugs are associated with the development of cancer, especially lymphoma, in children and young adults being treated for rheumatoid arthritis or Crohn's disease. The agency is investigating about 30 reports of cancer in this younger age group submitted between 1998, after the approval of the first TNF blocker, through April of this year. TNF blockers have also been linked to an increased risk of infection.
"I think it's a fair thing to say this is an area of ongoing concern that has not been resolved. It's not something new," said Dr. Chaim Putterman, chief of the division of rheumatology at Montefiore Medical Center and Albert Einstein College of Medicine in New York City. "[The drugs] were approved in adults, and more drugs are coming out, and everyone would prefer an indication in children, so the FDA has decided to clear it. It has always been a concern, and it's something that should be clarified."
Four TNF blockers are currently approved in the United States: Enbrel (etanercept), Humira (adalimumab), Remicade (infliximab) and Cimzia (certolizumab). 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.
The FDA review is focusing on the first three. All four are approved for multiple indications.
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Copyright © 2008 ScoutNews, LLC. All rights reserved.
Last updated 6/4/2008
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SOURCES: Chaim Putterman, M.D., chief, division of rheumatology, Montefiore Medical Center and Albert Einstein College of Medicine, New York City; Stephen Lindsey, head, rheumatology, Ochsner Health Service, Baton Rouge, La.; June 4, 2008, U.S. Food and Drug Administration statement
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