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Why the Product Labeling for Low-Dose Vaginal Estrogen Should Be Changed

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Why the Product Labeling for Low-Dose Vaginal Estrogen Should Be Changed Menopause: The Journal of The North American Menopause Society Vol. 21, No. 9, pp. 911/916 DOI: 10.1097/gme.0000000000000316 * 2014 by The North American Menopause Society EDITORIAL Why the product labeling for low-dose vaginal estrogen should be changed his commentary summarizes the activities of several of a highly effective local treatment of a common condition clinicians and researchers to encourage modifications with medical risks and adverse effects on quality of life. We Tto the labeling of low-dose vaginal estrogen. Motivated contend that the boxed warning for low-dose vaginal es- by concerns of practicing clinicians that the boxed warning on trogen products is unjustified based on several lines of rea- the labels and package inserts for these products overstate po- soning described below, including the following: (a) the tential risks and thus adversely affect patient care, leaders dramatic differences in blood hormone levels achieved by in the field are spearheading an effort to encourage consider- low-dose vaginal estrogen (eg, Vagifem tablets [estradiol ation of alternative labeling, as discussed below. The members 10 Kg], Estring [releasing estradiol 7.5 Kg/d], or comparable of the Working Group on Women’s Health and Well-Being in low-dose vaginal estrogen cream formulations) versus con- Menopause have affiliations with a number of medical socie- ventional systemic estrogen therapy; (b) absence of ran- ties, including The North American Menopause Society, the domized trial evidence or consistent observational evidence American College of Obstetricians and Gynecologists, the En- linking low-dose vaginal estrogen to cancer, cardiovascular docrine Society, the American Society for Reproductive Med- disease, dementia, or any of the other conditions highlighted icine, the International Society for the Study of Women’s in the boxed warning; and (c) absence of evidence that changes in Sexual Health, and other professional organizations. We appre- blood hormone levelsVof the small magnitude achieved with ciated the opportunity to share our concerns, literature review, these productsVincrease risk of these conditions. As a result and proposal for alternative labeling with members of the US of the boxed warning, a large number of older women with Food and Drug Administration (FDA) Division of Bone, Re- symptomatic VVA and genitourinary symptoms are being productive, and Urologic Products via a teleconference earlier undertreated and do not receive the substantial benefits that this year. We encourage further consideration of our rationale these medications could provide. and proposal by both the FDA and the pharmaceutical compa- We believe that women would be better served by a mod- nies that own these products. ified label that more closely reflects the safety profile of low- dose vaginal estrogen and would actually enhance safety by Overview of the proposal for label change emphasizing the key information that women and clinicians Vulvovaginal atrophy (VVA; also known as genitourinary need to know about the products. Our proposal is to state in syndrome of menopause) is a common and progressive con- the package labeling, in regular text and font, that estrogen dition that adversely affects the health and quality of life and estrogen-progestin given systemically, in higher doses, of many postmenopausal women.1 Symptomatic VVA is a have been linked to the health conditions currently noted in growing problem because of the confluence of several fac- the boxed warning, but that the relevance to low-dose vaginal tors, including the burgeoning population of older postmeno- estrogen remains unknown, given minimal increase in serum pausal women and the declining use of systemic menopausal estrogen levels with low-dose vaginal estrogen products. We hormone therapy since the initial report of the Women’s recommend bolding the phrase Breport any vaginal bleeding Health Initiative (WHI).2,3 Our view is that an additional or spotting right away while using ______.[ We also rec- factorVthe boxed warning on the package label for low-dose ommend adding in bold BWomen with a history of cancer of vaginal estrogenVdiscourages clinicians from prescribing the breast or uterus (womb), or other hormone-sensitive the product and women from taking it even after purchase. cancers, are encouraged to consult their oncologist before The boxed warning, which reflects estrogen class labeling, using this product.[ We believe that these label changes will, states BWARNING: ENDOMETRIAL CANCER, CAR- paradoxically, enhance patient safety because the relevant infor- DIOVASCULAR DISORDERS, BREAST CANCER, and mation and cautions will stand out and be highly visible, rather PROBABLE DEMENTIA[ and is based on extrapolations than being obscured by extraneous and alarming bolded and of data from clinical trials of systemic hormone therapy such boxed statements that lack proven relevance to the product. as the WHI, which involved substantially higher levels of Thus, the proposed label change would serve the purpose of in- exposure. We believe that the boxed warning is not forming women of previous research and addressing safety issues evidence-based and harms women by discouraging the use while stating that the relevance of past research findings on Menopause, Vol. 21, No. 9, 2014 911 Copyright © 2014 The North American Menopause Society. Unauthorized reproduction of this article is prohibited. EDITORIAL systemic hormone therapy to low-dose vaginal estrogen is infections12,13 and overactive bladder.14,15 Although systemic unknown. The specific suggested wording of our proposed hormone therapy has been associated with an increase in stress label change is provided at the end of this commentary. incontinence,8,16 the low-dose estradiol ring has been approved for the treatment of dysuria and urinary urgency. VVA has been Prevalence of VVA (Genitourinary Syndrome of linked to considerable impairment of quality of life; nonethe- Menopause) and the impact on women’s health and less, clinical studies demonstrate that a substantial proportion of quality of life women are undertreated.1 VVA symptoms, such as vaginal dryness, lack of lubrication, Moreover, in our collective clinical experience and in those pain or spotting with intercourse, and burning with urination, of the professional colleagues we represent, among women 4,5 affect 20% to 45% of midlife and older women. In contrast who seek treatment and/or receive prescriptions for low-dose to vasomotor symptoms, which tend to improve across time vaginal estrogen, a substantial proportion ultimately choose irrespective of treatment, VVA is usually progressive and un- not to use the product or discontinue use because of concerns likely to resolve without intervention. VVA symptoms can and alarm about the boxed warning in the package insert. have a significantly adverse effect on a woman’s sexual health Testimonials by working group members during the telecon- and quality of life. In an online survey conducted in six coun- ference with the FDA highlighted the adverse impact of VVA tries, an estimated 45% of postmenopausal women reported on women’s lives, including their physical, sexual, and emo- 6 experiencing vaginal symptoms. The largest survey of US tional health; clinical experience with the marked efficacy of women, REVIVE (Real Women’s Views of Treatment Options treatment; and the deleterious effect of the boxed warning on for Menopausal Vaginal Changes), included 3,046 women with 7 women’s health by discouraging clinician colleagues from VVA symptoms. In this study, 85% of women with partners prescribing, and women from using, these highly effective B [ reported some loss of intimacy, 59% indicated that VVA low-dose vaginal estrogen products. Specifically, several cli- symptoms detracted from enjoyment of sex, 47% of women nicians reported that many women who have purchased the low- with partners reported that VVA interfered with their relation- dose vaginal estrogen products, often at significant financial cost, ship, and 27% reported that VVA had a negative effect on their ended up not using them after reading the boxed warning. general enjoyment of life. Similar results were found in the 6 VIVA (Vaginal Health: Insights, Views & Attitudes) survey. Comparative blood concentrations of estrogens associated Aging and diminished estrogen levels are major contributors to 1,8 with low-dose vaginal estrogen versus systemic estrogens VVA, atrophic vaginitis, and recurrent urinary tract infections. versus no treatment Efficacy of treatment and impact of product BLow-dose[ vaginal estrogen refers to products such as labeling/boxed warning Estring (vaginal ring releasing estradiol 7.5 Kg/d), Vagifem As emphasized in the 2013 North American Menopause (10-Kg tablets two times a week), and comparable low doses Society VVA position statement,1 the primary goal of treating of vaginal creams (eg, Estrace [estradiol]) or Premarin [con- symptomatic VVA is to alleviate symptoms. First-line thera- jugated estrogens]).17 These products are considered to have pies include nonhormonal lubricants and long-acting vaginal a more favorable risk profile than commonly used doses of moisturizers, as well as low-dose vaginal estrogen in those systemic estrogen therapy because they lead to small, if any, remaining symptomatic, assuming no contraindications.1 For increases in serum estrogen concentrations.1,18<23 When low- women with moderate to severe dyspareunia related to VVA dose vaginal estrogen is used as directed, reported serum es-
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