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Divigel(R) (Estradiol Gel) 0.1% is One of a Newer Generation of Bioidentical Estrogens That is FDA-Approved for Relief of Hot Flashes, Including Night Sweats, From Menopause

Wednesday, July 7, 2010 Women Health News J E 4
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Estrogen in Divigel(R) is Derived from a Plant Source

MAPLE GROVE, Minn., July 7 /PRNewswire/ -- Women looking for the best method to manage common symptoms of menopause, like hot flashes and night sweats, may not have access to credible information, especially when it comes to understanding their estrogen therapy options.  In fact, there are an array of celebrities and authors who are simply not qualified to give medical advice about managing menopause, yet they dominate the internet and media space simply because of their popularity.  Many medical experts believe that the influence of these non-medical professionals has been an obstacle to women learning about the newer generation of bioidentical estrogens that are FDA-approved.  

"It is important that women understand what bioidentical hormones are and the differences between those that are FDA-approved and those that are compounded or "mixed" at the pharmacy level," said Dr. Ricki Pollycove, M.D.M.S., and author of "The Pocket Guide to BioIdentical Hormones."  "The surge of information surrounding compounded estrogen creams being touted by celebrities has left many women believing that the only way they can get individualized treatment for symptoms of hot flashes is through compounded pharmacies and that is simply not true since there are a variety of low dose bioidentical estrogens that are FDA-approved."

Compounded bioidentical formulations are often described as "custom" recipes of hormone formulations prepared by a pharmacist following an individual prescriber's order for a specific patient.  Compounded hormone products are not governed with the same type of oversight as commercial bioidentical estrogens that have been FDA-approved so they have not been tested for purity, potency, efficacy or safety.   Bioidentical estrogens that are FDA-approved have been tested according to specific protocols to ensure that they meet stringent guidelines for consistency.  Bioidentical estrogen that is FDA-approved is often also covered by many insurance plans or other patient saving programs.  Women should review their insurance coverage and discuss their options with a healthcare professional.

Traditional compounding is used to prepare medications in such instances as when a patient is allergic to an inactive ingredient in a commercially available product or requires an alternate form of administration. The FDA recognizes the need for this practice, but women should be aware that compounded drugs or formulations are not FDA-approved or tested for quality and potency.

"The bottom line is that if a woman wants to use bioidentical hormones to treat hot flashes from menopause, she should consider the fact that all FDA-approved non-oral estrogen products are also bioidentical and are tested for purity and consistency batch after batch," said Dr. Pollycove.

About Estradiol

Estradiol is synthetic, whether it is compounded by a pharmacist or pharmaceutically manufactured.  Bioidentical hormones are made by chemically changing a hormone-like substance from another source – for example soy or yams – to make it exactly the same structure as the hormones produced naturally in your body.  The estrogen in Divigel® is derived from plant sources and is identical to the primary estrogen produced by a woman's ovaries before menopause.

About Dr. Ricki Pollycove

Dr. Ricki Pollycove has practiced gynecology, focusing on breast disease, women's wellness and fertility, disease prevention, early detection of cancer and survivor care and advocacy since 1981. She has lectured widely to both consumers as well as medical professionals, with frequent appearances on local and national television as a women's health expert. Her first book, "Mother Nurture," Penguin 2002, focused on integrative self care during motherhood. "The Pocket Guide to BioIdentical Hormones" is intended to help women reassess their approach to the second half of life.

About Divigel®

Divigel® offers the lowest FDA-approved dose of estradiol in any gel, lotion or spray (0.25 mg estradiol) for moderate to severe hot flashes associated with menopause. Divigel® is available in three dosage strengths offering dosing flexibility to suit a woman's individual needs. Guidelines from the North American Menopause Society indicate that hormone therapy should be used at the lowest effective dose for the shortest amount of time, consistent with the treatment goals, benefits and risks for the individual woman.

Transdermal estrogen therapies (those applied to the skin), such as FDA-approved Divigel®, absorb directly into the bloodstream without having to pass through the liver like oral estrogen. This allows lower doses to be used and reduces exposure to high hormone levels. Transdermal administration also allows for relatively consistent estrogen levels throughout the day.  

For more information, women can visit patient education websites, such as http://www.menopause.org, www.ETIQ.info, the website devoted to empowering women with credible facts about menopause, or product specific websites, such as www.divigel.com.

More About Divigel®

Divigel® is a quick-drying gel that is odorless when dry and is available in convenient, individual-use packets. One packet of gel is applied daily to the upper thigh on an area that measures approximately 5 x 7 inches; the smallest application area compared to all other available gel or lotion estrogen products. After the gel is applied, estradiol absorbs directly into the bloodstream without having to pass first through the liver. Divigel® was approved by the U.S. Food and Drug Administration (FDA) in June 2007.

Important Safety Information for Patients

The following are not all the possible risks for Divigel®. Please see the full Prescribing Information and talk to your healthcare provider.

Estrogens increase the chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus. Your healthcare provider should check any unusual vaginal bleeding to find out the cause. In general, the addition of a progestin is recommended for women with a uterus to reduce the chance of getting cancer of the uterus.  

Do not use estrogens, with or without progestins, to prevent heart disease, heart attacks or strokes. Using estrogens, with or without progestins, may increase your chance of getting heart attacks, strokes, breast cancer and blood clots.  Do not use estrogens, with or without progestins, to prevent dementia. Using estrogens, with or without progestins, may increase your risk of dementia.  Do not use estrogen products, including Divigel®, if you have unusual vaginal bleeding, currently have or have had certain cancers, had a stroke or heart attack in the past year, currently have or have had blood clots, currently have or have had liver problems, are allergic to any Divigel® ingredients or think you may be pregnant.  The most common side effects for all estrogen products are headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps and bloating, nausea and vomiting, and hair loss. Less common but serious side effects include breast cancer, cancer of the uterus, stroke, heart attack, blood clots, dementia, gallbladder disease and ovarian cancer.  

In Divigel® clinical trials, the most common side effects were inflammation of the nasal passages and pharynx, upper respiratory tract infection, vaginal yeast infection, breast tenderness and vaginal bleeding. Call your healthcare provider right away if you have any symptoms that concern you.  Estrogen products should be used at the lowest dose possible for your treatment and only as long as needed. You and your healthcare provider should talk regularly about whether you still need treatment with Divigel®. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. For more information, call 1-800-654-2299 or visit www.divigel.com.

Upsher-Smith Laboratories, Inc.

Upsher-Smith Laboratories, Inc. is a rapidly growing pharmaceutical company that manufactures and markets both prescription and consumer products. Privately held since 1919, the company strives to recognize the unmet healthcare needs of our customers. Upsher-Smith prides itself in providing safe, effective, and economical therapies to the ever-challenged healthcare environment. For additional information about Upsher-Smith, visit www.upsher-smith.com.

Sources:

Pollycove, Ricki. The Pocket Guide to BioIdentical Hormones. 2010.  

The Endocrine Society, "Bioidentical Hormones," October 2006.

www.menopause.org/bioidenticalHT_Endosoc.pdf.

North American Menopause Society. "Understanding the Controversy: Hormone Testing and Bioidentical Hormones." 2007. www.menopause.org/edumaterials/PG06monograph.pdf.      

FDA Guidebook. http://fda.gov/ForConsumers/ByAudience/ForWomen/ucm118627.htm.

last updated June 2008. Accessed March 2010.

Divigel® [package insert]. Minneapolis, MN: Upsher-Smith Laboratories, Inc.; 2007.

Estrasorb® [package insert]. Bristol, TN: Graceway Pharmaceuticals, LLC; 2008.

EstroGel® [package insert]. Herndon, VA: Ascend Therapeutics, Inc.; 2007.

Elestrin™ [package insert]. Lincolnshire, IL: BioSante Pharmaceuticals, Inc.; 2007.

Evamist PI.

Altman, Alan, MD. "Bioidentical Hormones: What's Fact and What's Fable?" Sexuality, Reproduction & Menopause; April 2007.

FDA Consumer Health Information. "Bio-Identicals: Sorting Myths from Facts." April 8, 2008. www.fda.gov/consumer/updates/bioidenticals04082008.html

AACE Menopause Guidelines Revisions Task Force. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the diagnosis and treatment of menopause. Endocr Pract. 2006;12:315-337.

Scarabin PY, Oger E, Plu-Bureau G, on behalf of the ESTHER Study Group. Differential association of oral and transdermal estrogen replacement therapy with venous thromboembolism risk. Lancet. 2003; 362:428-432.

Shifren JL, Desindes S, McIlwain M, et al. A randomized, open-label, crossover study comparing the effects of oral versus transdermal estrogen therapy on serum androgens, thyroid hormones, and adrenal hormones in naturally menopausal women. Menopause. 2007;14(6):985-994.

SOURCE Upsher-Smith Laboratories, Inc.

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