EMA's PRAC recommends four-week limit for use of high-strength estradiol creams

The European Medicines Agency’s safety unit, the Pharmacovigilance Risk Assessment Committee (PRAC), has recommended limiting the use of high-strength creams containing 100 micrograms/gram (0.01%) of estradiol to a single treatment period of up to four weeks.

This measure, announced followed the latest PRAC meetings, is intended to minimize the risk of side effects such as blood clots, strokes and certain types of cancer caused by estradiol absorbed into the bloodstream from creams applied inside the vagina to treat symptoms of vaginal atrophy in women who have been through menopause.

The PRAC has reviewed all available data on the safety and effectiveness of high-strength estradiol-containing creams, including on the amount of estradiol in blood. These data showed that in postmenopausal women who had used these creams, the levels of estradiol in the blood were higher than normal postmenopausal levels.