European Medicine Agency’s safety committee (PRAC) has confirmed its recommendation to limit the use of high-strength creams containing 100 micrograms/gram (0.01%) of estradiol to a single treatment period of up to 4‑weeks.
What are estradiol-containing creams?
The estradiol-containing creams are a type of topical hormone replacement therapy. They contain the female hormone estradiol, used to replace natural estradiol, which declines in the body after menopause. These high-strength estradiol creams have been authorised in the EU for a number of years to treat symptoms of vaginal atrophy in postmenopausal women. They are marketed in Austria, Bulgaria, Croatia, Czech Republic, Estonia, Germany, Hungary, Latvia, Lithuania and Slovakia under the following trade names: Linoladiol, Linoladiol N, Linoladiol Estradiol, Estradiol Wolff and Montadiol.
Safety alert:
High-strength estradiol creams (100 micrograms/gram) applied inside the vagina should only be used for a single treatment period of a maximum of 4 weeks. This is because the hormone estradiol in these creams can be absorbed into the bloodstream and may increase the risk of side effects. similar side effects to those seen with hormone replacement therapy (HRT). The side effects of HRT taken orally or used transdermally (as patches) include venous thromboembolism (formation of blood clots in the veins), stroke, endometrial cancer (cancer of the lining of the womb) and breast cancer.
High-strength estradiol cream should not be used if you are already taking another HRT (hormone replacement therapy) medicine.
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