BMS, IMS, EMAS, RCOG and AMS joint statement on menopausal hormone therapy and breast cancer risk in response to EMA Pharmacovigilance Risk Assessment Committee recommendations in May 2020

Abstract

The EMA Pharmacovigilance Risk Assessment Committee has mandated a safety update, specifically regarding breast cancer risk, to the Summary of Product Characteristics (SmPC) of all estrogencontaining MHT products. The update recommended emphasizing the increased risk of breast cancer with both estrogen-only and estrogen and progestogencontaining MHT. This recommendation appears to follow on from the CGHFBC meta-analysis and does not appear to take into consideration the findings from the Women’s Health Initiative (WHI) randomized trials findings nor their recent long-term follow-up data. The aim of this Position Statement is to make recommendations on best practice in the care of women with menopausal symptoms in response to the EMA Pharmacovigilance Risk Assessment Committee recommendations in May 2020. We recognize that the menopause transition can have a significant impact on many women, with more than 75% experiencing menopausal symptoms, a quarter describing severe symptoms which may last as much as seven years or more and a third experiencing longterm symptoms. MHT, compared with placebo, has been consistently shown to improve menopausal symptoms and it remains the most effective treatment that is also associated with significant improvement in overall quality of life. We strongly believe that the findings from the CGHFBC meta-analysis should be considered in the context of the overall benefits obtained from using MHT, as referred to in this Position Statement. Key messages from the BMS, IMS, EMAS, RCOG and AMS position statement