EU Panel: Don't Use Estradiol Creams for Longer Than 4 Weeks

Troy Brown, RN


October 07, 2019

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) recommends capping the use of high-strength creams that contain estradiol 100 μg/g (0.01%) at a single treatment period of no longer than 4 weeks.

The reason for this recommendation is to lower the risk for adverse effects, such as blood clots, strokes, and certain types of cancer, which can result from absorption of estradiol into the bloodstream from intravaginal creams used to relieve vaginal atrophy symptoms in postmenopausal women.

The recommendation appears in highlights from the PRAC meeting held from September 30 to October 3.

The European Commission requested the review, which was initiated in April 2019, after a ruling by the European Union Court of Justice that "partially annulled the conclusions of a previous PRAC review of these medicines in 2014 on procedural grounds."

The Court of Justice accepted the scientific conclusions; however, this partial annulment invalidated some of the measures implemented to reduce the risk.

The PRAC's recommendation follows consideration of all available safety and efficacy data on high-strength estradiol-containing creams, including the amount of the hormone in the 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," according to the meeting highlights.

The new recommendations will be added to the prescribing information for these estradiol creams, along with a warning that they be used for no more than a single treatment period of no longer as 4 weeks. This warning will be on the outer and inner packaging, and the tube size will be no larger than 25 g to prevent more extended use than recommended.

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