The European Medicines Agency’s (EMA) safety committee has recommended limiting use of high-strength creams containing 100Âµg/gram (0.01% w/w) of estradiol to a single treatment period of up to four weeks.
This comes after data on the safety and effectiveness of high-strength estradiol-containing creams showed that postmenopausal women who used the creams to treat symptoms of vaginal atrophy had raised levels of estradiol in their blood.
Following a review requested by the European Commission in April 2019, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), concluded that absorption of estradiol in the bloodstream was a concern and could increase the risk of side effects linked to users of hormone replacement therapy (HRT), such as venous thromboembolism, stroke and breast cancer.
High-strength estradiol creams should, therefore, not be used by women already on HRT.
Prescribing information for these creams will be updated with the recommendation that they should only be used for a single treatment period of a maximum of four weeks, and a warning will be placed on the outer and inner packaging.
The size of the tube will also be limited to 25g to prevent use for longer than recommended.
The PRAC’s recommendations will now be sent to the Coordination Group for Mutual Recognition and Decentralised Procedures — Human (CMDh) to make a decision about their implementation.
The CMDh represents EU member states as well as Iceland, Liechtenstein and Norway.