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The Food and Drug Administration said it has received 30 reports of children and young adults developing cancer while taking the drugs over the last 10 years. Roughly half the cases were lymphomas, a type of immune-system cancer. Others reported were leukaemia, melanoma and cancers of various organs.
The drugs under review include Abbott Labs' Humira, Schering-Plough's Remicade (known in South Africa as Revellex), and Enbrel (also available in SA), which is marketed by Amgen Inc. and Wyeth. They are prescribed to children with arthritis to block a chemical that causes inflammation.
The drugs are also used to treat children with the intestinal disorder Crohn's disease.
Investigation to focus on risk to kids
The products, known as tumour necrosis factor blockers, are key revenue drivers for the companies. Abbott's Humira was the company's best-selling product last year with over $3 billion in sales. Remicade also topped Schering-Plough's portfolio with sales of $1.65 billion.
The safety of Humira was reviewed in February when the FDA first cleared it for use in juvenile arthritis, Abbott said in a statement. The company has not recorded any instances of lymphoma in children.
Representatives from the other companies did not immediately return calls for comment.
The FDA said the drugs' labelling already warns of a potential association with cancer, but the agency's investigation will focus on risks to younger patients.
The statement posted to the FDA's website said it will take long-term studies to definitively assess the drugs' safety risks since cancers take years to develop.
Doctors warned to take note of risks
Belgian drug maker UBC is conducting a long-term study of risks, including cancer, with its drug Cimizia, which is part of the medication class. But the FDA said that study won't be complete until 2019.
The agency has asked drug makers to provide all information about children who developed cancer while taking the medications.
Regulators will report the findings of their review by November. Doctors should consider the risks of cancer when considering prescribing the drugs for youngsters, the FDA said. – (Sapa)
June 2008
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