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TNF blockers to carry cancer warning

Anti-inflammatory drugs known as TNF blockers are to carry stronger warnings about the increased risk of sometimes fatal cancer

Anti-inflammatory drugs known as tumour necrosis factor (TNF) blockers are to carry stronger warnings about the increased risk of sometimes fatal cancer in children and adolescents, the Food and Drug Administration (FDA) has said.

The decision concludes an investigation that began last year, in which the regulator examined a possible link between anti-TNF therapies and cancer. Analysis of reports of cancer in patients receiving the drugs showed that the increased risk occurred "after 30 months of treatment on average".

Around half of the cancers were lymphomas and some of the reported cancers were fatal, the FDA noted.

Revised prescribing information and updated boxed warnings will affect Johnson & Johnson's and Schering-Plough's Remicade (infliximab) and Simponi (golimumab); Amgen and Wyeth's Enbrel (etanercept); Abbott's Humira (adalimumab) and UCB's Cimzia (certolizumab).

The FDA has said it is working with the manufacturers to better determine the risk of cancer in children and adolescents who use the drugs, which are used to treat rheumatoid arthritis and the bowel ailment Crohn's disease, along with other inflammatory diseases.

5th August 2009

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