Incorrect Estrogen Warning Has Women in A Black Box

Vaginal estrogen is safe for women to use

Mature female patient with mobile phone in hospital waiting room
Vaginal Dryness Is Treatable Safely. Phil Fisk/Cultura/Getty Images

Vaginal dryness and uncomfortable sex as a result of it is one of the most common complaints of women in menopause. As a matter of fact, out of the 64 million women in menopause in the United States, 32 million are struggling with this problem.

At this year's Annual Meeting of the North American Menopause Society, this was a very talked about topic and the reason is really important for you to know.

Surveys done show that very few women ever discuss this problem (only 10 percent to 20 percent ) and only 7 percent are actually treated.

A lot of the reason why it is so undertreated has to do with fear of estrogen. It turns out that the FDA requires that every estrogen-containing product is required to have a Black Box warning that states that the use of estrogen can lead to breast cancer, heart disease and dementia. This information comes from a flawed study published in 2002 called the WHI or Women's Health Initiative study.

When women read the package insert, they often will not feel safe using vaginal estrogen. As a result, 32 million have vaginal dryness or a condition called vulvo-vaginal atrophy (now called genitourinary syndrome of menopause). What that means is the tissue of the vagina become thinner and dryer and narrower. It is all due to lower estrogen levels and it's easy to understand that women would want to be treated for those symptoms.

Here are the reasons the numbers treated are so low and why so few women get treated or ever talk about this challenging problem:

1) because the symptoms start about 2-3 years after menopause, it doesn't seem related to menopause 2) many women don't know there are effective treatments 3) many women are embarrassed to discuss it and 4) many women believe vaginal estrogen will be helpful but are worried about getting breast cancer from vaginal estrogen.

I want to address this last point - reason 4. There is virtually no risk that taking vaginal estrogen will lead to breast cancer. It is true that small amounts of estrogen placed into the vagina may get into the blood stream. But how much? According to psychologist and sex therapist Dr. Sheryl Kingsberg, if you were to use the vaginal estrogen pill Vagifem for instance for one year, the amount of estrogen that would get into the blood stream would be approximately the same amount that would get into your blood stream from taking the birth control pill for one day. One year of treatment = one day of the pill.

But because the FDA requires that every estrogen-containing product has a "black box" warning that says estrogen can cause breast cancer, even though there is no evidence that vaginal estrogen can cause breast cancer, women shy away. If women take estrogen shortly after they enter menopause for 5 years and in some situations much longer, there is actually a statistically significant reduction in breast cancer.

Relief of painful sex and vaginal dryness doesn't have to be something you grin and bear. In November of 2016, there will be a hearing in congress to try and get the "black box" warning removed. I hope we are successful in achieving that. In the meantime, if you are one of the 32 million women with painful sex or vaginal dryness, talk with your healthcare provider about vaginal estrogen.

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