FDA Approves Lower Dose of Prempro, a Combination Estrogen and Progestin Drug for Postmenopausal Women

FDA today approved a lower dose single tablet of Prempro, containing 0.45 estrogen and 1.5 progestin (medroxyprogesterone) to treat specific symptoms of menopause. A progestin is needed when a postmenopausal woman uses estrogen and has a uterus (womb) because estrogens may increase the risk of uterine problems and a progestin lowers the chance of having these problems.

Prempro is effective for treating moderate to severe symptoms of hot flashes and night sweats and is indicated for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy (burning, itching, and dryness in and around the vagina). However, topical vaginal products should be considered when being prescribed solely for the treatment of symptoms of vulvar and vaginal atrophy.

The new lower dose will provide an additional option for postmenopausal women. FDA continues to advise women to talk to their doctors and, if they decide that estrogen and progestin containing products are appropriate, they should use the lowest dose for the shortest duration to reach treatment goals.

“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 Mark B. McClellan, M.D., Ph.D.

“However, these treatments also have important risks, and should be used in the lowest dose and for the least duration required to provide relief. Today’s action gives postmenopausal women a lower-dose option for getting the benefits of estrogen and estrogen with a progestin treatment,” he said.

FDA is developing science-based informational materials on its latest guidance on estrogens and estrogens with progestins, and will work closely with women’s health organizations, community-based organizations and other experts to get this information out to women and health- care providers.

FDA encourages health researchers to continue to explore answers to important questions arising from the Women's Health Initiative study (WHI). FDA emphasizes that it is not yet known, following the landmark WHI study, which doses will decrease safety concerns.

Postmenopausal women who use or are considering the use of these treatments should discuss with their physicians whether the benefits outweigh the risks for them individually.

FDA reminds women that estrogens and progestins should not be used to prevent heart disease, heart attacks, or strokes.

Wyeth Pharmaceuticals, a division of Wyeth of St. Davids, Pa., manufactures Prempro. The company has advised that the new lower dose will be available in a few months.

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