Estrogen to be Available Over the Counter

Estrogen to be Available Over the Counter

Estrogen may soon be available as an over the counter medication…

In the UK.


Understanding the Issue

Estrogen and hormone therapy (HT) for menopause symptoms has been controversial in the United States since a 2002 study called the Women’s Health Initiative Study (WHI) incorrectly reported an increase risk in breast cancer and heart disease. The key findings of the study have since been disproven, but not before usage of hormone therapy dropped more than eighty percent.


As a result, estrogen, which was once the #1 prescription medication in the United States, is now being used by only eight percent of menopausal women. The remainder of women are either toughing out their menopause symptoms, using less effective treatments, or using treatments that are symptom specific and don’t offer possible benefits for their entire body.


Background information about vaginal estrogen

Even vaginal estrogen, which is highly beneficial for women with vaginal dryness or painful sex is required by the FDA to place a black box warning on the packaging. The black box warning warns women that vaginal estrogen can increase the risk of breast cancer and heart disease even though there is no data to support that. In fact, major medical organizations such as the American College of Obstetrics and Gynecology (ACOG) have published opinion statements that show research to prove that even for women with estrogen receptor positive breast cancer, there is no increased risk of death or recurrence from breast cancer following usage of vaginal estrogen, though they do suggest trying non-estrogen options initially.


What is being proposed

Things are different in the UK. The Medicines and Healthcare products Regulatory Agency (MHRA) has proposed making Gina (estradiol hemihydrate) 10-µg vaginal tablets available to menopausal women in the UK at pharmacies as an over the counter remedy.


This new proposal would also reclassify the local hormone therapy (HT) product to enable women to purchase it without the need for a prescription.


The UK proposal now under consideration plans to seek opinions from PCPs, pharmacists, and members of the public on making local vaginal estrogen available to women aged 50 years and older, who have had the menopause for at least a year.


The UK is also far ahead of the United States in realizing that menopause plays a major role in women’s ability to perform at their peak in the workplace and have put policies into play in approximately ten percent of businesses that take into account the need to support the business woman in midlife.  In the United States, only about one percent of businesses address this issue.

Safety Concerns

With six thousand women entering menopause in the United States, and vaginal dryness and painful sex an extremely common menopause symptom that is embarrassing for many women to discuss, most women are currently not being treated for this problem. Only a very small amount of the medication is absorbed into the bloodstream. In clinical studies, less than 7 milligrams of local vaginal estrogen are absorbed from the vagina in an entire year, compared with 365 milligrams per year of absorbed estrogen from the typical birth control pill. Vaginal estrogen such as the one being recommended in the UK for over the counter use is mostly staying in the vagina where it is needed.


Bottom Line

Allowing women easy access to local vaginal estrogen at pharmacies will likely allow millions of women suffering from painful sex and vaginal dryness to have access to a hugely beneficial treatment that they currently may be too embarrassed to discuss or that their providers may not ask them about. It is a real step forward.


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