An appeal to reverse the European Medicines Agency’s (EMA’S) recent safety notice on high-strength oestradiol creams has failed.
In October 2019 the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended limiting the use of high-strength oestradiol creams containing 100 μg/g (0.01%) to a single treatment period of up to four weeks due to the risk of systemic exposure to oestradiol.
Pharmacokinetic data on high-strength intravaginal oestradiol creams show systemic exposure to oestradiol, with levels up to five times above the upper reference limit of postmenopausal oestradiol serum levels of 10-20 pg/ml. Systemic exposure to oestradiol could be associated with side effects similar to those of oral and transdermal hormone replacement therapy (HRT), such as endometrial, breast and ovarian cancer, and thromboembolic events.
Following the decision, one of the companies that market high-strength oestradiol creams requested a re-examination of the recommendation.
At its January meeting, the PRAC reported that it has reviewed available data and concluded that absorption of oestradiol into the bloodstream is of concern and reaffirmed its October decision.
The PRAC recommendations will now be sent to the committee for mutual recognition, which will decide on the implementation of the decision in EU member states, Iceland, Liechtenstein and Norway.