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Connecticut files Thalomid petition

May 5, 2005 12:40 AM UTC

Connecticut Attorney General Richard Blumenthal submitted a Citizen's Petition to FDA requesting that the agency strengthen warnings on the label of Celgene's Thalomid thalidomide. The petition asks FDA to strengthen the drug's "black box" warning statement to stress the risks of blood clots when Thalomid is used in combination with chemotherapy drugs and to require that CELG conduct a Phase IV trial to characterize risks and benefits in cancer patients, as well as strengthen its risk management program.

Thalomid is approved to treat erythema nodosum leprosum but gets most of its sales from off-label use for multiple myeloma (MM). The label contains a warning of thrombotic events but says that it is not known whether concomitant use with other medications, including chemotherapy, is a contributing factor. ...