MAPLE GROVE, Minn., Jan. 27 /PRNewswire/ -- Clinical and experimental evidence suggests that non-patch, transdermal estrogen therapies, such as Divigel(R) (estradiol gel 0.1%), prescribed for the management of moderate-to-severe hot flashes, including night sweats, associated with menopause are effective alternatives to oral estrogen and compounded bioidentical hormones.(1) A review of the evidence was recently published in the January issue of the Journal of Women's Health, authored by Nina Carroll, MD, of Beth Israel Deaconess Medical Center and Brigham and Women's Hospital. The Journal of Women's Health is the official peer-reviewed journal of the American Medical Women's Association (AMWA).
About the Manuscript
The article addresses a wide spectrum of issues surrounding the treatment of menopausal symptoms including variability in estradiol dosing and the differences between bioidenticals that are FDA-approved and non-FDA-approved compounded bioidentical formulations. Dr. Carroll elaborates on the risks and benefits of oral and transdermal hormone therapies with a focus on five non-patch, transdermal estradiol therapies currently available in the United States. She also discusses the misconceptions surrounding custom-mixed (compounded) estrogen and FDA-approved estrogen.
About Transdermal Delivery Systems
Transdermal estrogen avoids first-pass metabolism, a process where the amount of a drug taken in is reduced before it reaches systemic circulation because a portion is metabolized in the liver. Avoiding first-pass metabolism allows for lower doses of hormones and establishes more consistent and more physiologic estrogen and metabolite blood levels. To achieve therapeutic levels, oral hormones require higher doses of estrogen than transdermals due to the first-pass metabolism in the liver.(2, 6)
Current Estrogen Prescribing Recommendations
Current recommendations for hormone therapy from the U.S. Food and Drug Administration (FDA), the North American Menopause Society (NAMS), and the American College of Obstetricians and Gynecologists (ACOG) suggest the use of the lowest effective dose for the shortest duration of time, consistent with treatment goals, benefits and risks for the individual woman regardless of the delivery method.(1)
About Divigel(R)
Divigel(R) is a bioidentical transdermal gel and is FDA approved for the treatment of moderate-to-severe vasomotor symptoms (hot flashes) associated with menopause. The estrogen in Divigel(R) is derived from plant sources and is identical to the primary estrogen produced by a woman's ovaries before menopause. Divigel(R) 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(R) offers the lowest FDA-approved dose of estradiol in any gel, lotion or spray (0.25 mg estradiol). Divigel(R) is available in three dosage strengths offering dosing flexibility to suit a woman's individual needs.(8-12)
Important Safety Information for Patients
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 dementia. Using estrogens, with or without progestins, may increase your risk of dementia.
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.
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(R). 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.
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.
CONTACT: Kelly Williams of The Reilly Group, +1-773-348-3800, Ext. 205,
kellywilliams@thereillygroup.com, for Upsher-Smith Laboratories, Inc.
Web site: http://www.upsher-smith.com/
