FDA to re-examine its 1976 approval of hot flashes treatment
Friday, April 11th 2003, 12:00 am
By: News On 6
WASHINGTON (AP) _ Federal health officials are taking a second look at a treatment for menopausal hot flashes, saying their approval of the hormone combination 27 years ago was not based on substantial evidence.
The Food and Drug Administration said in a statement Thursday that the combination of estrogen and androgen features in two marketed products, but did not name them.
The FDA would allow the products to remain available while it undertakes the re-examination of its 1976 approval, the statement said.
The combination is marketed as treatment for women who do not find relief for hot flashes when using estrogens alone, it said. The treatment has also recently been marketed as relief for female sexual dysfunction.