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Your Health

Medical Community Takes Fresh Look At Hormone Therapy For Menopause Symptoms

Posted: 12/18/2013

Women bothered by moderate to severe menopausal symptoms should speak with their doctors about treatment
Women bothered by moderate to severe menopausal symptoms should speak with their doctors about treatment.

(NAPSI)—It’s a fact: up to 85 percent of menopausal women suffer from hot flashes.1 While hot flashes and other symptoms are a common rite of passage in menopause, opinions on treatment with hormone therapy (HT) have been anything but universal—but that is changing.

Recently, 15 top medical organizations issued a statement of agreement that HT for the treatment of menopause symptoms is acceptable and relatively safe for healthy, symptomatic, recently postmenopausal women.2 The statement was prepared by The North American Menopause Society (NAMS), the American Society for Reproductive Medicine (ASRM), and The Endocrine Society and jointly endorsed by 12 other leading women’s health organizations. According to its authors, the purpose of the statement was to provide reassurance in the decade-long debate about HT, which began with the publication of the controversial Women’s Health Initiative (WHI) in 2002.

“We believe that too many symptomatic women are missing out on the proven benefits of hormone therapy because the results of the WHI, which studied the long-term use of hormones to prevent chronic disease, were misinterpreted for women with menopausal symptoms,” Dr. Margery Gass, executive director for NAMS, said in a press release about the joint statement. “Women and clinicians are frustrated by the many conflicting recommendations. That’s why we initiated this effort to bring these notable medical organizations together in agreement regarding the use of hormone therapy.”

Health experts encourage women who are bothered by moderate to severe menopausal symptoms to speak with their doctors about the possibility of treatment with HT. “Physicians can help patients determine, based on their own particular characteristics and history, whether or not they are good candidates for hormone therapy and what type of HT will provide them the greatest relief at the lowest risk,” Roger Lobo, MD, Past President of the ASRM said in the press release.

If a woman thinks hormone therapy might be right for her, she should ask her doctor about prescription estrogens which continue to be the most effective option for relieving the discomfort of hot flashes and night sweats associated with menopause.3 The FDA recommends the lowest effective dose with any estrogen therapy for the shortest amount of time to achieve personal treatment goals.4 A physician may prescribe Divigel® (estradiol gel) 0.1%, a bioidentical,5 transdermal estrogen gel with the lowest FDA-approved dose of transdermal estradiol gel or spray (0.25 mg/day estradiol) for hot flashes.6-9 Divigel® is used to treat moderate to severe hot flashes due to menopause. Generally, women should be started at 0.25 mg/day of Divigel®.

For patients who are prescribed Divigel®, saving money is easy and just a few clicks away at divigel.com. Patients can print the Patient Savings Coupon, bring it to their local pharmacy, and pay no more than $25 on their Divigel® co-pay amount. The Patient Savings Coupon is for eligible patients only and limited to a maximum savings of $25 each on 12 Divigel® prescriptions. Offer expires on June 30, 2014.

Important Safety Information for Patients

What is the most important information I should know about Divigel® (an estrogen hormone)?

  • Using estrogen-alone increases your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using Divigel®. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual bleeding to find out the cause.
  • Do not use estrogen-alone to prevent heart disease, heart attacks, strokes or dementia (decline of brain function)
  • Using estrogen-alone may increase your chances of getting strokes or blood clots
  • Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older
  • Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes or dementia
  • Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
  • Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older
  • You and your healthcare provider should talk regularly about whether you still need treatment with Divigel®

Divigel® 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; currently have or have had blood clots, currently have or have had liver problems, have been diagnosed with a bleeding disorder, are allergic to Divigel® or any of its ingredients, or think you may be pregnant.

Tell your healthcare provider about all of your medical problems and the medicines you take, if you are going to have surgery or will be on bed rest, and if you are breastfeeding.

Call your healthcare provider right away if you get any of the following symptoms: new breast lumps, unusual vaginal bleeding, changes in vision or speech, sudden new severe headaches, or severe pains in your chest or legs with or without shortness of breath, weakness and fatigue.

Common side effects that may occur with Divigel® include headache; breast pain; irregular vaginal bleeding or spotting; stomach or abdominal cramps, bloating; nausea and vomiting; hair loss; fluid retention and vaginal yeast infection.

Serious but less common side effects include heart attack, stroke, blood clots, dementia, breast cancer, cancer of the uterus, ovarian cancer, high blood pressure, high blood sugar, gallbladder disease, liver problems, and enlargement of benign uterus tumors (“fibroids”).

Alcohol-based gels are flammable. Avoid fire, flame or smoking until the gel has dried.

Please see Patient Information for Divigel® and talk to your healthcare provider. For more information, call 1-888-650-3789 or visit www.divigel.com.

You are encouraged to report negative side effects to Upsher-Smith Laboratories, Inc. at 1-855-899-9180, or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

For more information about hot flashes, talk to your doctor, and visit www.divigel.com to learn more about this treatment.

Divigel® is marketed in the U.S. by Upsher-Smith Laboratories, Inc.

©2013 Upsher-Smith Laboratories, Inc., Maple Grove, MN 55369

References

1. Hot Flashes. Listen to Your Body. http://www.drnorthrup.com/womenshealth/healthcenter/topic_details.php?topic_id=130. Accessed September 18, 2013.

2. 15 Top Medical Organizations Agree on Hormone Therapy Use; 10 Years Have Passed Since Women’s Health Initiative Raised Questions. Joint press release issued by The North American Menopause Society, American Society for Reproductive Medicine and The Endocrine Society. July 9, 2012. http://www.menopause.org/docs/default-document-library/pr12solidarity.pdf?sfvrsn=2. Accessed September 18, 2013.

3. Shanafelt TD, Barton DL, Adjei AA, Loprinzi CL. Pathophysiology and treatment of hot flashes. Mayo Clin Proc. 2002;77(11):1207-1218.

4. US Food and Drug Administration. Menopause and Hormones. http://www.fda.gov/ForConsumers/ByAudience/ForWomen/ucm118624.htm. Accessed September 18, 2013.

5. The North American Menopause Society. Menopause Guidebook. 7th ed. Mayfield Heights, OH: The North American Menopause Society; 2012.

6. Divigel® [package insert]. Minneapolis, MN: Upsher-Smith Laboratories, Inc.; 2012.

7. EstroGel® [package insert]. Herndon, VA: ASCEND Therapeutics, Inc.; 2009.

8. Elestrin™ [package insert]. Philadelphia, PA: Azur Pharma, Inc.; 2012.

9. Evamist [package insert]. St. Louis, MO: Ther-Rx Corp.; 2011.

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