FDA OKS Version of Hormone Therapy Drug
Posted on: Thursday, 13 March 2003, 06:00 CST
Associated Press -- A low-dose version of the combination hormone used by many women to treat symptoms of menopause was approved Thursday by the Food and Drug Administration.
The agency appeoved a Prempro tablet containing 0.45 milligram of estrogen ansd 1.5 milligram of progesterone.
That combination of hormones is a common treatment for hot flashes, night sweats and other symptoms, but many women discontinued their use after a research panel reported last fall that women using the drugs are at higher risk of cancer and heart disease than had originally been thought.
"Based on the latest evidence, FDA believes that estrogens and estrogen with progestin products provide valuable therapy for many postmenopausal women, particularly those with hot flashes and those with vaginal dryness," said FDA Commissioner Dr. Mark B. McClellan.
"However, these treatments also have important risks, and should be used in the lowest dose and for the least duration required to provide relief," he said.
The combination product is used for postmenopausal women who still have their uterus because estrogens may increase the risk of cancer of the utrerus and a progestin lowers the risk.
By comparison to the new product with 0.45 mg estrogen and 1.5 mg protesterone the version of Prempro that has been on the market contained 0.625 mg estrogen and 2.5 mg progesterone. Both are made by Wyeth Pharmaceuticals.
Wyeth said clinical tests showed the new low-dose version was effective in treating the symptoms of menopause. It is expected to be available in early summer.
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