Thalidomide Approved for Bone Marrow Cancer
But drug's label cites risks of blood clots, birth defects
FRIDAY, May 26, 2006 (HealthDay News) -- Thalidomide -- a drug banned in 1962 after it caused thousands of birth defects -- has been approved in the United States to treat bone marrow cancer, the U.S. Food and Drug Administration said Thursday.
The drug can be used to treat newly diagnosed multiple myeloma, which affects cells in the bone marrow that play a critical role in fighting infection. The drug will be used in conjunction with dexamethasone, a standard chemotherapy treatment, the Associated Press reported.
Studies assessing thalidomide's effectiveness in treating multiple myeloma have produced mixed results. A study published in March concluded that the drug did not prolong patients lives, while a second study published around the same time said that thalidomide did help extend the lives of older patients, but caused serious side effects.
In 1998, the FDA approved thalidomide as a treatment for leprosy. Even before this week's approval, thalidomide was widely prescribed for multiple myeloma in so-called "off-label" use.
The FDA currently requires thalidomide labeling to carry severe warnings about the risk of birth defects. The new labeling will also warn about the risks of blood clots in the legs and lungs in multiple myeloma patients who take thalidomide in conjunction with dexamethasone, the AP reported.
The FDA has more about thalidomide.