STUDY: Formal inquiry of the estrogen/androgen combination it approved for hot flashes back in 1976

JOURNAL: FDA

AUTHORS:

ABSTRACT: U.S. health officials questioned the effectiveness of a combination hormone therapy for treating hot flashes in women and said unapproved uses, such as restoring sex drive, must also be proven.

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COMMENTARY: The U.S. Food and Drug Administration said it was launching a formal inquiry of the estrogen/androgen combination it approved for hot flashes back in 1976.

The FDA said it knew of at least two currently marketed products affected by its action but did not name them.Belgian drug maker Solvay markets two estrogen/androgen combinations under the name Estratest.

"FDA is acting because it does not believe there is substantial evidence that androgens contribute to the effectiveness of these combination products to treat hot flashes in menopausal women who do not find relief from these symptoms when using estrogens alone".

The agency said it was aware that these products were being prescribed for female sexual dysfunction, a use not covered by the 1976 approval.While there might be significant benefits of such unapproved uses of a drug, the FDA said, there were important benefits in demonstrating safety and effectiveness through well-planned clinical investigations.

Debate has raged for years over the use of post-menopausal hormone therapy beyond hot flashes and night sweats, amid conflicting reports over whether it prevents brittle bones and heart disease.