Embrel Among Drugs Under Study By FDA for Cancer Risk in Kids

By Ventura County Star, Calif.

Jun. 5–Federal regulators are investigating whether a group of arthritis drugs made by Abbott Laboratories, Schering-Plough Corp. and other companies heighten the risk of cancer in youngsters.

The Food and Drug Administration said Wednesdaythat it has received 30 reports of children and young adults developing cancer while taking the drugs over the last 10 years.

The drugs include Abbott Labs’ Humira, Schering-Plough’s Remicade, and Enbrel, which is marketed by Amgen Inc. and Wyeth

The drugs are prescribed to children with arthritis to block a chemical that causes inflammation. The drugs also are used to treat children with the intestinal disorder Crohn’s disease.

Amgen and Wyeth said in a joint statement Wednesday that they are committed to patient safety and supported the FDA’s ongoing review of safety information for that class of drugs.

The companies said they would continue to provide the agency with information.

FDA said the drugs’ labeling already warns of a potential association with cancer, but the agency’s investigation will focus on risks to younger patients.

The agency has asked drug makers to provide all information about children who developed cancer while taking the medications.

Regulators will report findings of their review by November.

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