Wyeth updates labels for postmenopausal hormone therapiesST. DAVIDS, PA., September 4, 2002 -- Wyeth Pharmaceuticals announced that it has updated the package inserts for its postmenopausal hormone therapies Prempro, Premphase (conjugated estrogens/medroxyprogesterone acetate tablets) and Premarin (conjugated estrogens tablets, USP).
This update reflects recent safety information, primarily from the NIH study known as the Women's Health Initiative (WHI). The company says it initiated this action so that physicians will have up-to-date information in order to counsel their postmenopausal patients on appropriate use of its hormone therapies.
Wyeth has sent letters to physicians informing them about the update.
"Wyeth will continue to work closely with the medical community and regulatory authorities to further refine its product labels for all of its postmenopausal hormone therapies, regardless of the estrogen or progestin used," said Victoria Kusiak, M.D., Vice President, Global Medical Affairs, North American Medical Director for Wyeth.
The updated labels also state that:
- These products are not indicated and should not be used to prevent coronary heart disease.
- Use should be limited to the shortest duration consistent with treatment goals and risks for the individual woman and should be periodically reevaluated.
- When used solely for the prevention of postmenopausal osteoporosis, alternative treatments should be carefully considered.
For women who have not had a hysterectomy, Prempro and Premphase are indicated for:
- Treatment of moderate to severe vasomotor symptoms associated with the menopause
- Treatment of vulvar and vaginal atrophy
- Prevention of postmenopausal osteoporosis
These are also indications for Premarin, which is used alone by women who have had a hysterectomy, or in combination with a progestin by women who have not had a hysterectomy.
"Wyeth recognizes that physicians are working hard to counsel the millions of women who use combination postmenopausal hormone therapy and have questions about the latest information from the Women's Health Initiative," continues Dr. Kusiak. "We believe this new information will assist them in assessing each patient's individual risks and treatment goals."
Premarin is approved for the treatment of moderate to severe hot flashes and night sweats associated with menopause, the treatment of vaginal dryness, and the prevention of postmenopausal osteoporosis.
Prempro and Premphase are approved for women with an intact uterus for the treatment of moderate to severe hot flashes and night sweats associated with menopause, the treatment of vaginal dryness, and the prevention of postmenopausal osteoporosis.
Premarin, Prempro, and Premphase are not approved and should not be used to prevent coronary heart disease.
The use of estrogen alone in nonhysterectomized, postmenopausal women has been reported to increase the risk of endometrial carcinoma. Doctors may prescribe a progestin along with estrogen to reduce this risk.
Because of the potential increased risk of heart attack, stroke, breast cancer, and blood clots, use of Premarin, Prempro, or Premphase should be limited to the shortest duration consistent with treatment goals and risks for the individual woman and should be discussed with her physician regularly. If you have been prescribed Premarin, Prempro, or Premphase for the prevention of postmenopausal osteoporosis only, alternative treatments should be carefully considered.
Posted: September 2002