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Why Women Need More than 'Female Viagra'

It is good news that the FDA is paying greater attention to female sexual health, and that eligible patients will have a new treatment option to try. However, this drug will help only a limited number of women for several reasons.
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Lisa Dabney, M.D.
Faculty Attending Physician
Department of Obstetrics and Gynecology
Mount Sinai Roosevelt and Mount Sinai St. Luke's

Why Women Need More than 'Female Viagra'

The U.S. Food and Drug Administration (FDA) recently gave the green light to the first drug to treat low sexual desire in women, a complex disorder that has a variety of possible causes and contributing factors. Dubbed "female Viagra" by the media, Addyi is approved for use in premenopausal women who are distressed by low libido that is unrelated to medical or psychiatric conditions, relationship problems, or medication side effects. It targets brain chemicals that are linked to sexual excitement, but researchers don't fully understand how it works.

It is good news that the FDA is paying greater attention to female sexual health, and that eligible patients will have a new treatment option to try. However, this drug will help only a limited number of women for several reasons, including marginal effectiveness, patient age limit, prescribing restrictions, a daily dosing regimen, and the risk of dangerous side effects, particularly in women who drink alcohol.

By one estimate, low sexual desire disorder affects about 10 percent of American women. A far more common cause of female sexual dysfunction is dryness and thinning of vaginal tissue due to a lack of estrogen, the primary female sex hormone. These tissue changes often lead to pain during sexual intercourse, a problem reported by about 44 percent of postmenopausal women. (The body stops making estrogen after menopause.) This condition can also affect women who are breastfeeding, as the body shuts down estrogen production during lactation.

A Simple, But Underused, Solution

Unlike management of low sexual desire disorder, there is a simple, safe, and effective treatment for this cause of sexual dysfunction: vaginal estrogen medication. This topical drug delivers a very low dose of estrogen directly to vaginal tissue. Unfortunately, many women who could be helped by vaginal estrogen needlessly go untreated because of alarm over the package insert's unnecessary "black box" warning -- the strongest prescription drug warning.

Ever since a large clinical trial in 2002 showed that estrogen-plus-progestin hormone therapy taken by mouth poses a small risk of several serious conditions, the FDA has required this level of warning to appear on the labels of all estrogen-containing products. The problem is that the results of this study were based on oral "systemic" forms of estrogen, which are absorbed into the bloodstream and travel throughout the body. Consequently, even though low-dose topical estrogen products act mostly in the vagina and release little estrogen into the bloodstream, they needlessly carry the same FDA warning as the oral pills.

Studies show that most women can safely use vaginal estrogen, with the possible exception of those with severe forms of breast cancer. It does not interact with other medications and has only a few potential side effects, such as skin sensitivity to inactive ingredients. That's why I counsel many of my patients to ignore the warning (I ask those with breast cancer to check with their oncologists first). In fact, in 2014, a group including The North American Menopause Society and The American College of Obstetricians called on the FDA to change the labeling language of vaginal estrogen to encourage its use and better reflect its safety profile.

Using Topical Estrogen

Using a non-medicated lubricant like K-Y Jelly for vaginal dryness may temporarily relieve pain during sexual intercourse for some women, and is reasonable to try first. However, it does not address the underlying tissue changes caused by lack of estrogen, which can also lead to irritation and pain in the vagina outside of sex. In contrast, topical estrogen medication works at the microscopic level to replenish the vaginal cells with estrogen, thereby restoring the tissue and reversing dryness. As a side benefit, this treatment promotes the growth of "good" bacteria that can help prevent recurrent urinary tract infections -- another common problem for postmenopausal women.

Vaginal estrogen comes in four different formulations: two creams (Premarin and Estrace), which you insert into the vagina using a small plastic applicator twice a week; a suppository tablet (Vagifem), also used twice a week; and an estrogen-releasing, flexible ring (Estring) that stays inside the vagina continuously and you replace every three months.

Postmenopausal women typically use topical estrogen long-term, since their natural estrogen production has ceased. Some women may be able to take a break from the medication and continue to feel better for some time, but the problem will generally recur. Women who are breastfeeding can stop taking it altogether once they cease nursing and their natural estrogen levels return to normal.

Talk to Your Doctor

Discussing one's sex life at a doctor's visit can be awkward, but your health care provider is there to care for your whole being. If you are having problems with sexual functioning, treatment options are available, so don't be afraid to talk with your gynecologist to see if any are right for you. Doing so could help improve the quality of life for you and your partner.