Currently affecting over 50,000 people in the United States, multiple myeloma is a blood cancer that causes the overproduction of plasma cells, a type of white blood cell. Left untreated, the disease can cause anemia, kidney damage, increased susceptibility to infection and osteoporosis. There is no cure, but with the right treatment it can be managed.
While thalidomide is often prescribed off-label for the management of multiple myeloma, the Food and Drug Administration is now reviewing the results of the study to consider approving this drug specifically for the treatment of this cancer. Thalidomide is already approved for this use in Australia, Israel, New Zealand and Turkey.
The most common side effects reported by study participants were insomnia, tremors and dizziness. However, ten percent of the patients taking thalidomide suffered from deep vein thrombosis, a disease that causes dangerous blood clots to form. In contrast, fewer than two percent of patients taking just dexamethasone had this problem.
And while thalidomide does still carry a serious risk of birth defects, both Celgene, the company that manufactures thalidomide, and the FDA have agreed on guidelines to ensure that patients do not become pregnant while taking the drug. This program requires all women taking the drug to use two forms of contraception, and men must use latex condoms if they have sex. All patients must undergo monthly reviews, including pregnancy tests for women, before they can receive a new prescription for the drug.
"It's a check and balance system," said Christy Celli, medical information specialist for Celgene.
