DUAVEE was developed by Wyeth Pharmaceuticals, a wholly-owned subsidiary of Pfizer, and is part of a broader research collaboration with Ligand Pharmaceuticals Incorporated.About Menopause Menopause is a normal, natural event. It marks the permanent end of fertility and is usually confirmed when a woman has not menstruated for 12 consecutive months . Menopause is associated with reduced functioning of the ovaries due to aging, resulting in lower levels of estrogens and other hormones . Changes in these hormones cause symptoms of menopause, which may include hot flashes  and bone loss . While menopause is natural, many women have not discussed treatment options for their symptoms with their doctor . “Millions of women suffer from menopausal symptoms, despite the availability of effective hormone therapies,” said Risa Kagan, MD, FACOG, Clinical Professor, Obstetrics and Gynecology, University of California San Francisco and East Bay Physicians Medical Group. “DUAVEE is an excellent option for symptomatic menopausal women who have a uterus. I’m excited to be able to offer this new, novel approach to treating moderate-to-severe menopausal vasomotor symptoms for the many women who could benefit.” About Osteoporosis Osteoporosis, the most common bone disease in humans, becomes a serious health threat in postmenopausal women . Lower levels of estrogens at the time of menopause are associated with rapid bone loss, and an increased risk of osteoporosis . Approximately 50 percent of women in the U.S. 50 years of age or older have low bone mass, putting them at risk for osteoporosis . IMPORTANT SAFETY INFORMATION Do not take additional estrogens, progestins, or estrogen agonists/antagonists while taking DUAVEE. Using estrogen may increase your chance of getting cancer of the uterus. Report any unusual vaginal bleeding right away while taking DUAVEE. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus. A healthcare provider should check unusual vaginal bleeding to find the cause. Do not use estrogens to prevent heart disease, heart attacks, strokes or dementia. Estrogens may increase the chance of getting blood clots or strokes. Using estrogens may increase the chance of getting dementia, based on a study of women 65 years of age or older. DUAVEE should not be used in women who: have or had blood clots; are allergic to any of its ingredients; have unusual vaginal bleeding; have or had certain cancers (e.g. uterine or breast), liver problems, or bleeding disorders; or are pregnant, may become pregnant or are breastfeeding a baby . The use of estrogen-alone has been reported to result in an increase in abnormal mammograms requiring further evaluation. The effect of treatment with DUAVEE on the risk of breast and ovarian cancer is unknown.
Estrogens increase the risk of gallbladder disease. Discontinue estrogen if loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs.The most common side effects include muscle spasms, nausea, diarrhea, upset stomach, abdominal pain, throat pain, dizziness, and neck pain. INDICATIONS DUAVEE is used after menopause for women with a uterus, to reduce moderate to severe hot flashes and to help reduce the chances of developing osteoporosis. If using or considering using DUAVEE only to prevent osteoporosis due to menopause, talk to a health care professional about whether a different treatment or medicine without estrogens might be more appropriate. Use DUAVEE for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary. Please see full prescribing information, including boxed warning on www.pfizer.com. Pfizer Inc.: Working together for a healthier world™ At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more, please visit us at www.pfizer.com . PFIZER DISCLOSURE NOTICE: The information contained in this release is as of October 3, 2013. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information that involves substantial risks and uncertainties about DUAVEE. Such risks and uncertainties include, among other things, the uncertainty regarding when DUAVEE will be available in the U.S.; uncertainty regarding the commercial success of DUAVEE in the U.S.; whether and when regulatory authorities in markets other than the U.S. will approve any applications that have been or may be filed for DUAVEE as well as their decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K/A for the fiscal year ended December 31, 2012 and in its reports on Form 10-Q and Form 8-K.
|1||Pfizer DOF. Duavee USPI Sept. 2013.|
|2||Kharode Y, Bodine P, Miller C, Lyttle R, Komm B. The pairing of a selective estrogen receptor modulator, bazedoxifene, with conjugated estrogens as a new|
|paradigm for the treatment of menopausal symptoms and osteoporosis prevention. Endocrinology. 2008;149:6084-6091|
|3||Howden L and Meyer J. Age and Sex Composition: 2010. 2010 US Census Briefs. United States Census Bureau. 2011. 1-15.|
|4||The North American Menopause Society. Menopause Practice: A Clinician’s Guide. 4(th) Edition. 4(th) Ed. Mayfield, OH: NAMS; 2010.|
|5||Data on file. Pfizer Inc, New York, NY. [U.S. National Health and Wellness Survey. Kantar Health, 2011.]|
|6||The Endocrine Society. Lake Research. New Survey: Majority of women suffering menopausal symptoms are not receiving treatment; many not talking to doctors|
|about treatment options. 2012.|
|7||Weismiller D. Menopause. Prim Care Clin Office Pract. 2009;36:199-226|
|8||Crabtree J, Peano B, Zhang X, Komm B, Winneker R, Harris H. Activity of three selective estrogen receptor modulators on hormone-dependent responses in the|
|mouse uterus and mammary gland. Mol Cell Endocrinol. 2008;287:40-46.|
|9||Looker A, Melton L, Harris T, Borrud L, Shepher J. Prevalence and trends in low femur bone density among older US adults: NHANES 2005-2006 compared with|
|NHANES III. J Bone Miner Res. 20010;25(1):64-71|