Vaginal Estradiol International Purchase Legalities: What You Need to Know Before You Buy

Can vaginal estradiol bought abroad be imported?

This page cannot establish whether an order from a Canadian, European, Mexican or other foreign pharmacy is permitted for import into the United States. FDA's BeSafeRx can help a buyer check an online pharmacy [3], but that check does not determine import legality. Practical checks are the exact vaginal product and its label [1], whether the product offered is compounded [2], and the online pharmacy itself [3].

What the US vaginal product is

Estradiol Vaginal Cream 0.01% is indicated for moderate to severe symptoms of vulvar and vaginal atrophy due to menopause [1]. The label's usual dosage is 2 to 4 g daily for one or two weeks, then half that dose for a similar period, with a maintenance dose of 1 g one to three times a week after the vaginal mucosa has been restored [1]. The label says use should be limited to the shortest duration consistent with treatment goals and risks for the individual woman, with periodic reevaluation of whether treatment is still necessary [1].

Oral estradiol tablets and transdermal estradiol patches are separate products with their own labels, indications and warnings [4][5].

What the cream's label warns about

Systemic absorption may occur with Estradiol Vaginal Cream 0.01%, and the label says the warnings, precautions and adverse reactions associated with oral estrogen treatment should be taken into account [1]. The label carries a boxed warning covering endometrial cancer, cardiovascular disorders, breast cancer and probable dementia. It says estrogen-alone therapy should not be used to prevent cardiovascular disease or dementia [1].

Reactions the label lists with estrogen or progestin therapy include application-site vulvovaginal burning and irritation, genital itching, abnormal uterine bleeding or spotting, breast tenderness and pain, nausea and vomiting, abdominal cramps and bloating, headache, migraine, dizziness and edema [1].

Compounded estradiol and online sellers

Compounded drugs are not FDA-approved, and FDA does not verify their safety, effectiveness or quality before they are marketed. FDA says compounded drugs should be used only when a patient's needs cannot be met by an FDA-approved drug [2]. FDA notes that people who buy compounded drugs online may not know which compounder produced the product, and that buying any medicine from unregulated, unlicensed online sources can expose patients to poor-quality products [2].

FDA's BeSafeRx campaign explains how to recognize the signs of a safe online pharmacy and includes a lookup for state-licensed online pharmacies [3].