Joint EMAS, IMS and ESSM response to EMA advice regarding high-strength estradiol vaginal creams

The European Medicine Agency on October 4th warned both consumers and prescribers against the use of high-strength estradiol creams for longer than 4 weeks [1]. These high dose creams are marketed in Austria, Bulgaria, Croatia, Czech Republic, Estonia, Germany, Hungary, Latvia, Lithuania and Slovakia.

Genitourinary syndrome of menopause affects more than half of postmenopausal women. The syndrome comprises of genital, urinary and sexual symptoms, which have a significant impact on health and quality of life. While the high-strength preparations included in the EMA recommendation may increase the circulating concentrations of estradiol, those currently in use in most of Europe and worldwide provide much lower doses, with negligible effects on systemic levels. The safety of these low-dose preparations has been confirmed by many studies, which have shown no adverse effects.

Given the prevalence of genitourinary syndrome of menopause and the efficacy and safety of low-dose preparations in current use, the European Menopause and Andropause Society (EMAS), the International Menopause Society (IMS) and the European Society for Sexual Medicine (ESSM) recommend that low-dose preparations should continue to be used in women who need them.

Antonio Cano, EMAS President
Susan Davis, IMS President
Yacov Reisman, ESSM President