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Thalidomide OK'd for Multiple Myeloma

FDA Approves Thalidomide With Strict Rules to Prevent Birth Defects
WebMD Health News
Reviewed by Louise Chang, MD

May 26, 2006 -- The FDA has approved thalidomide -- a drug known to cause severe birth defects -- to help treat newly diagnosed multiple myelomamultiple myeloma, a cancercancer of the bone marrow.

Thalidomide was approved for use in combination with another drug, dexamethasone, for multiple myeloma. Thalidomide will be sold under the name Thalomid by Celgene Corporation. The drug will come in capsules in doses of 50 milligrams, 100 milligrams, and 200 milligrams.

The FDA had previously approved thalidomide -- with strict rules to help prevent birth defects -- to treat debilitating and disfiguring skin sores associated with erythema nodosum leprosum, an inflammatory complication of leprosy.

Those strict rules are also in place for Thalomid's use in patients with newly diagnosed multiple myeloma.

"If thalidomide is taken during pregnancypregnancy, it can cause severe birth defects or death to an unborn baby," states the drug's warning label. "Thalidomide should never be used by women who are pregnant or who could become pregnant while taking the drug," the label continues.

Thalidomide also carries the risk of potentially dangerous clots in the veins, including deep vein thrombosis (DVT) and pulmonary embolismpulmonary embolism. DVT are clots in the deep veins of the legs. Pulmonary embolism is a clot that travels through the bloodstream to the lungs.

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