EMA’s safety committee recommends a 4-week limit for use of high-strength estradiol creams
The European Medicines Agency (EMA)’s pharmacovigilance risk assessment committee (PRAC) has recommended limiting the use of high-strength estradiol vaginal creams (containing 100 micrograms/g or 0.01%) to a single treatment period of up to 4 weeks.
The PRAC review concluded that in postmenopausal women who had used these creams, the levels of estradiol in the blood were higher than normal postmenopausal levels and could result in similar side effects to those seen with systemic (oral or transdermal) hormone therapy (HT).
The side effects of HT include venous thromboembolism, stroke, endometrial cancer, and breast cancer.
In the absence of safety data for long-term use of high-strength estradiol creams, the PRAC recommended that these creams should only be used for a single treatment period of a maximum of 4 weeks. This formulation should not be used in patients already on HT. Other vaginal estrogen formulations are available and may be preferred.
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The diagnosis is clinical, based on the absence of menses for 12 months, and does not require further testing for appropriately presenting patients.
Estrogen therapy is an effective treatment for the management of menopausal symptoms including hot flashes, night sweats, and urogenital symptoms.
For women with an intact uterus, a progestin must be co-administered with an estrogen to protect against endometrial hyperplasia and cancer.
Arbitrary limits should not be placed on the duration of use of hormone therapy (HT); all patients require individualized decision-making. Reassessment should occur at least annually. Transdermal administration of estradiol is associated with a lower risk of stroke and venous thromboembolism than oral administration of estradiol and is unlikely to increase the risk of stroke and venous thrombosis above that of non-users.
Nonhormonal interventions may help women who have a contraindication to, or cannot tolerate, HT. However, they are less effective than HT in controlling menopausal symptoms.
Onset of menopause is heralded by the cessation of menses for at least 12 consecutive months, without some other reason for amenorrhea (such as pregnancy, hormone therapy, or other medical condition). No further testing is indicated for amenorrhea in an appropriate clinical context or symptoms of menopause in a woman without a uterus.
Permanent cessation of ovarian function may occur surgically by removal of both ovaries (surgical menopause) or medically, usually due to chemotherapy or radiation therapy (treatment-induced menopause).
The perimenopause includes the years before and after the cessation of menses in an ovulating woman and is marked by irregular menses and menopausal symptoms. Management of menopause symptoms requires individualization based on each woman’s clinical circumstance.
History and exam
Clinical Director Women and Sexual Health
NHS Dumfries and Galloway
Dumfries and Galloway Royal Infirmary
HC declares that she has received sponsorship, educational grants, speaker fees, funding for attendance at meetings, and advisory board fees from several pharmaceutical and non-pharmaceutical companies, which supports the running and development of Menopause Matters Ltd.
Clinical Lead for Menopause Service
King's College Hospital NHS Trust
HH declares that he has acted in an advisory capacity for Bayer. HH received a research grant to support a clinical trial and support to attend academic conferences from Besins.
Independence Park Medical Services
BWF is a consultant for Advance Medical and Kevin Trangle Associates and is on the Speakers Bureau for Abbvie.
Dr Heather Currie, Dr Haitham Hamoda, and Dr Bradford W. Fenton would like to gratefully acknowledge Dr Rebekah Wang-Cheng, a previous contributor to this topic.
Department of Obstetrics and Gynecology
Virginia Commonwealth University
NGOC declares that she has no competing interests.
CS declares that she has no competing interests.
Honorary Senior Lecturer and Clinical Director
Department of Obstetrics and Gynaecology
Norfolk and Norwich University Hospital
EM declares that he has no competing interests.
Professor of Medicine and Obstetrics & Gynecology
Obstetrics and Gynecology
Columbia University in New York Medical Center
MW has received research funding from Ferring and Pfizer Wyeth; has acted as an advisory board consultant for Pfizer Wyeth, QuatRx, and Yoplait; and is on the speakers' bureau of Amgen, Upsher Smith, and Warner Chilcott. MW is also an author of a reference cited in this topic.
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