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medpundit |
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Friday, April 11, 2003The Food and Drug Administration has begun proceedings to remove from the market the only estrogen-and-testosterone combination pill for sale in the United States. The agency has asked the company that makes Estratest to produce evidence that the drug treats hot flashes in menopausal women who don't get relief from estrogen supplements alone. The FDA approved Estratest in 1976. Research since then has suggested that there isn't good evidence that adding testosterone to estrogen provides better relief for hot flashes, an FDA source said. It seems a little drastic to remove it from the market just because it isn't better than other hormones. Wouldn't it suffice to tell the company not to claim that the drug's superior, and save the market removal for drugs that have proven to be harmful? Sometimes Estratest is used to try to enhance libido, but evidently that isn't a proven use, either: In a statement, the agency said it is also concerned because estrogen-testosterone pills are being prescribed for "female sexual dysfunction" -- loss of libido -- which was not one of the uses approved in 1976. posted by Sydney on 4/11/2003 07:40:00 AM 0 comments 0 Comments: |
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