TNF companies comply with FDA investigation

6/13/2008

WASHINGTON The Food and Drug Administration’s safety review of tumor necrosis factor blocker drugs that may be associated with lymphoma and other cancers has received support from pharmaceutical companies. The drugs in question are Amgen and Wyeth’s Enbrel, Abbott’s Humira, Centocor and Schering-Plough’s Remicade and UCB Pharma’s Cimzia.

Amgen said it provided the FDA with information from its adverse events database and Wyeth’s database and is continuing to work with the agency to evaluate the overall risk-benefit ratio of Enbrel in pediatric patients. Immunex, a subsidiary of Amgen, manufactures Enbrel, which Amgen and Wyeth market in North America and Wyeth markets elsewhere.

Last week, the FDA said it was investigating approximately 30 reports of cancer, submitted to its Adverse Event Reporting System, in patients taking the blockers for juvenile idiopathic arthritis, Crohn’s disease and other diseases during a 10-year period ending April 29.

The FDA cited a possible risk to children and young adults who take TNF blockers along with such other immuno-suppressive medications as methotrexate, azathioprine or 6-mercapturine.

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