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FDA Probes Arthritis Drug Link To Cancer

Drugs are used to treat arthritis in children, young adults

June 4, 2008

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The U.S. Food and Drug Administration has announced an investigation into a class of drugs used to treat arthritis, over concerns they might be linked to the development of cancer.

The agency said it has received 30 reports in the last ten years that the drugs, called tumor necrosis factor blockers, caused cancer in children and young adults.

While arthritis is usually thought to be an affliction of middle and old age, this class of drug is used to treat forms of the disease that affect younger people. The blockers are prescribed to treat Crohn's disease and idiopathic arthritis, among other conditions.

One of the drugs in question, Enbrel, is a joint venture between Amgen and Wyeth. The two drug-makers have issued a statement in support of the FDA review, but expressing confidence in the safety of Enbrel.

"Amgen provided the FDA with information from both companies' adverse events databases and is continuing to work with the Agency to evaluate the overall risk benefit of Enbrel in pediatric patients," the statement said.

The two drug companies note that the FDA has been aware of the possible association between the use of TNF blockers and the development of cancers, since the prescribing information for all four TNF blockers warns about the possible risk of cancer. Despite that, they point to an FDA Early Communication on the issue that said the FDA believed 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."

Until the evaluation is completed, the FDA said 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. Amgen and Wyeth said they agreed with that position.

Enbrel was first approved for juvenile idiopathic arthritis (JIA), formerly called juvenile rheumatoid arthritis, in 1999, and is the only approved use for Enbrel in the pediatric population.

The drug is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages 2 and older. ENBREL has been studied in JIA for up to nine years in controlled and open-label portions of a clinical study, the two companies said.

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