Estrasorb

FDA Talk Paper
T03-69
October 10, 2003
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA



FDA Approves Estrasorb For Treatment of Menopausal Hot Flashes
FDA approved Estrasorb (estradiol topical emulsion), an estrogen therapy product in a topical form. Current estrogen products available for treatment include oral pills, transdermal patches, and a ******* ring. Estrasorb has been proven effective for treating moderate to severe symptoms of hot flashes and night sweats associated with menopause.

Estrasorb is a white lotion-like emulsion that women apply only to their legs, thighs or calves on a daily basis. The product is absorbed through the skin into the blood stream to achieve its effect. As a precaution women are advised not to apply sunscreen and Estrasorb at the same time because this may affect the amount of estradiol absorbed.

In January 2003, FDA advised women and their doctors that menopausal hormone therapy – estrogen and estrogen with progestins – may be associated with an increased risk of heart disease, heart attacks, strokes, and breast cancer. This was based on the findings of the Women’s Health Initiative (WHI) conducted by the National Institutes of Health (NIH). Label warnings and cautions for Estrasorb are similar to other menopausal hormonal therapy products.

To help women make decisions about whether to take hormone therapy, FDA and NIH initiated a nationwide information campaign to raise awareness about the recent WHI findings. FDA, NIH and a variety of organizations developed a menopause and hormone-therapy fact sheet, and a purse guide that women can use to discuss their options with a health professional. These materials are available in both English and Spanish from the National Women's Health Information Center (NWHIC) at www.4woman.gov.

Based on the latest evidence, FDA believes that estrogens and estrogen with progestin products, such as this new product, provide valuable therapy for many postmenopausal women, particularly those with “hot flashes.” FDA reminds women that 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 new option for getting the benefits of estrogen.

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 also reminds women that estrogens and estrogen with progestin products should not be used to prevent heart disease, heart attacks, or strokes.

Estrasorb is manufactured and distributed by Novavax, Columbia, Md.