Elestrin estradiol gel 0.06%

Menopause
and Treatment Options

Herbal Treatments

"Natural" Doesn't Always Mean Effective

If you look on the shelves of your local pharmacy, you're bound to see "natural" remedies that claim to relieve hot flashes. Soy-based products and herbs such as black cohosh and red clover are frequently cited for their ability to treat menopausal symptoms. You may even know some women who rely on them.

In analyzing these claims, it's important to keep in mind that herbal treatments of menopause have not been determined to be safe and effective by the US Food and Drug Administration (FDA). Because they are not FDA-approved, they do not have to go through the same rigorous clinical tests as prescription products. Currently, there is no substantial scientific evidence that has found these herbal treatments to be effective for treating hot flashes. In fact, in a large, one-year study that tested the effectiveness of 3 different herbal remedies in relieving hot flashes, none of the herbal remedies were found to work any better than placebo (substance containing no medicine) at reducing symptoms. In this same study, hormone therapy was shown to significantly reduce hot flashes associated with menopause.1

What About Bioidenticals?

You may have heard about a type of hormone therapy formulation called "natural" or "bioidentical" hormones. The term bioidentical is confusing at times and is often used to refer to hormones that are compounded (or custom-mixed) by pharmacists. There are a number of misleading claims associated with compounded bioidenticals. To get the straight story, click here.

All estrogen therapy has risks. Please see important safety information at the bottom of this page.

Indication

Elestrin is indicated for the treatment of moderate-to-severe hot flashes and night sweats associated with menopause.

Important Safety Information

Estrogens, with or without progestins, should not be used for the prevention of cardiovascular disease or dementia (decline in memory or thinking skills). Estrogen and progestin therapy has shown an increased risk of breast cancer, heart attack, and blood clots. Estrogen therapy, with or without progestins, increases the risk of stroke and dementia. Estrogen therapy alone increases the risk of cancer of the uterus (womb).

Elestrin should not be used if you have unusual vaginal bleeding; currently have or have had certain cancers, including cancer of the breast or uterus; had a stroke or heart attack in the recent past; currently have or have had blood clots; currently have or have had liver problems; or think you may be or know that you are pregnant.

The most frequently reported adverse events in clinical trials were nose and throat irritation, breast tenderness, upper respiratory tract infection, and irregular menstrual bleeding.

You and your healthcare provider should discuss whether Elestrin is right for you or whether you still need treatment with Elestrin.

Estrogens, with or without progestins, should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Please see full Prescribing Information, including Boxed Warning and Patient Information Sheet.

You are encouraged to report negative side effects of prescription drugs to the FDA (Food and Drug Administration).
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information, call 1-800-890-3098.

Reference

  1. Newton KM, Reed, SD, LaCroix AZ, Grothaus LC, Erlich K, Guiltinan J. Treatment of vasomotor symptoms of menopause with black cohosh, multibotanicals, soy, hormone therapy, or placebo. Ann Intern Med. 2006;145(12):869-879.