Medical Community Takes Fresh Look At Hormone Therapy For Menopause Symptoms

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(NAPSA}—It’sa fact: up to 85 percent of menopausal womensuffer from hot flashes. While hot flashes and other symptoms are a commonrite 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 symptomsis acceptable andrelatively safe for healthy, symptomatic, recently postmenopausal women.* 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 purposeof the statement was to provide reassurance in the decade-long debate about HT, which began with the publication of the controversial Women’s HealthInitiative (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 hormonesto prevent chronic disease, were misinterpreted for women with menopausal symptoms,” Dr. Margery Women bothered by moderate to severe menopausal symptoms should speak with their doctors about treatment. Gass, executive director for NAMS, said in a press release about the joint statement. “Womenandclinicians are frustrated by the manyconflicting recommendations. That’s why weinitiated this effort to bring these notable medical organizations together in agreement regarding the use of hormonetherapy.” Health experts encourage women whoare 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 ontheir own particular characteristics and history, whether or not they are good candidates for hormonetherapy and whattype of HT will pro- vide them the greatest relief at the lowestrisk,” Roger Lobo, MD, Past President of the ASRM said in the press release. If a woman thinks hormone therapy mightberightfor her, she should ask her doctor about prescription estrogens which continue to be the mosteffective option for relieving the discomfort of hot flashes and night sweatsassociated with menopause? The FDA recommendsthe lowest effective dose with any estrogen therapy for the shortest amount of time to achieve personal treatment goalsA physician mayprescribe Divigel (estradiol gel) 0.1%, a bioidentical,* transdermalestrogen gel with the lowest FDA-approved doseof transdermal estradiol gel or spray (0.25 mg/day estradiol) for hot flashes.Divigel is used to treat moderate to severe hot flashes due to menopause. Generally, women should be started at 0.25 mg/dayof Divigel’. For patients who are prescribed Divigel, saving money is easy andjust a few clicks away at divigel.com. Patients can print the Patient Savings Coupon,bringit to their local pharmacy, and pay no more than $25 on their Divigel co-pay amount. The Patient Savings Couponis 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 Whatis the most important information I should know about Divigel? (an estrogen hormone)? * Using estrogen-alone increases your chanceof getting cancer of the uterus (womb). Report any unusual vaginalbleeding right away while you are using Divigel’. Vaginal bleeding after menopause may be a warning sign of cancerof the uterus (womb). Your healthcare provider should check any unusualbleedingto find out the cause. Donot use estrogen-alone to prevent heart disease, heart attacks, strokes or dementia (decline of brain function) Using estrogen-alone may increase your chancesofgetting strokes orblood clots Using estrogen-alone mayincrease your chanceofgetting dementia, based on a study of women 65 yearsof ageor older Donotuseestrogens with progestins to preventheart disease, heart attacks, strokes or dementia Using estrogens with progestins may increase your chancesof getting heart attacks, strokes, breast cancer,or blood clots Using estrogens with progestins may increase your chanceofgetting dementia, based on a study of women65 years ofage or older You and your healthcare provider should talk regularly about whether youstill need treatment with Divigel Divigel should not be usedif you have unusual vaginalbleeding, currently have or have had certain cancers, includingcancerof the breast or uterus, had a stroke or heart attack; currently have or have hadblood clots, currently haveor have hadliver problems, have been diagnosed with a bleeding disorder, are allergic to Divigel or anyofits 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 goingto have surgery orwill be on bed rest, andif you are breastfeeding. Call your healthcare provider right away if you get any ofthe following symptoms: new breast lumps, unusual vaginal bleeding, changes in vision or speech, sudden new severe headaches, or severe pains in your chestor legs with or without shortness of breath, weakness andfatigue. Commonsideeffects 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 commonsideeffects include heart attack, stroke, blood clots, dementia, breast cancer, cancer ofthe uterus, ovarian cancer, high blood pressure, high blood sugar, gallbladder disease, liver problems, and enlargementof benign uterus tumors(“fibroids”). Alcohol-basedgels are flammable. Avoidfire, flame or smoking until the gel has dried. Please see Patient Informationfor Divigel and talk to your healthcare provider. For more information,call 1-888-650-3789or visit www.divigel.com. You are encouraged to report negative side effects to Upsher-Smith Laboratories, Inc. at 1-855899-9180,or to the FDAbyvisiting www.fda.gow/medwatchorcalling 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. Divigelis marketedin the U.S. by Upsher-Smith Laboratories, Inc. 2013 Upsher-Smith Laboratories, Inc., Maple Grove, MN 55369 References 1, Hot Flashes, Listen to YourBody, htspi/ynw-dmmorthnapcomframensheskthfhealthcenterftopie_details,php2apie_1d=100. Accessed September 18, 2073 18 Tep Medical Organizations Agree on Hormone TherapyUse; 10 Years Hare Passed Since Women's Heslth Initiative Raised Questions, dcint press releaseissued by The North “American Menopause Society, American Society for Reproductive Medicine and The Endocrine Society. July9, 2012. hiup:wmrw:mencpause.orgldeesfdefeult-decumentWoraryfprl2sclidarityndtsforsn=2. Accessed September 18, 2013 3. Shanafelt TD, Barton DL, Adjei AA, Loprinzi CL. Pathophysiology and trestmentofhot flashes. Mayo Clin Proc. 2003)7701):1207-1218, 4. US Pood and DragAdministration. Mlenepause and Hormones. htxp:/fwarfda gewRerConsumers/ByAudience/RorWemenfuem118624 him. Aecessed September 18, 2073 5, ‘The North American Menopause Society. Menopause Cuidebeck., 7th ed. Mayfield Heights, OF: The North American Menopause Society, 2012 8. Divigel ipaclage insert], Minnespelis, MN: Upsher-Smith Laberstaries, Ine; 2012 1 EstreCiel[package insert]. Hernden, VA: ASCEND Therapeutics, Ine; 2009, a lestrin™ [package insert]. Philadelphia, PA: Azur Pharma, Tne.; 2012 6 [Bramist ipackage insert], St.Louis, IMO: Ther-Rx Cerp.; 2071 1 }98081.01