US FDA Approves Remicade for Pediatric Crohn's Disease

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US FDA Approves Remicade for Pediatric Crohn's Disease

WASHINGTON (Reuters) May 19 - U.S. regulators said on Friday they approved & 's drug Remicade for treating children with Crohn's disease.

The Food and Drug Administration also said it received reports of rare cases of an aggressive and often-fatal lymphoma in adolescents and young adults treated with Remicade. The FDA is working with & to add this information to the drug's warning label, an agency statement said.

The company is aware of six reports of hepatosplenic T-cell lymphoma in Crohn's disease patients who took Remicade for varying lengths of time, said Parks, a spokesman for & unit Centocor.

It is unclear if Remicade contributed to the lymphoma cases, he added. The patients also were treated with other immunosuppressive drugs.