4 things to know before getting ‘the little pink pill’

FDA approves Addyi for female sexual desire disorder, but there’s a lot more to this condition that needs to be explored.
(Sprout Pharmaceuticals for Spectrum Health Beat)
FDA approves first drug to treat sexual desire disorder. (Sprout Pharmaceuticals for Spectrum Health Beat)

Problem: A large number of women don’t feel like having sex and they’re upset by their extremely low libido and the havoc it’s wreaking on their relationships and self-image.

Solution: Let’s make a pill for that.

It appears Sprout Pharmaceuticals has.

The U.S. Food and Drug Administration has approved Addyi (flibanserin), a daily, non-hormonal oral drug to treat generalized hypoactive sexual desire disorder in premenopausal women.

Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women.

“It’s good to have another tool available to help women who are struggling with this issue,” said Diana Bitner, MD, an OB/GYN, certified menopause physician and women’s sexual health specialist with Spectrum Health Medical Group.

“Whether or not this particular treatment is the right course of action, it helps open the door for a discussion between a woman and her doctor about her sexual desire. Together, they can then determine the best way forward.”

Male vs. female desire

Hypoactive sexual desire disorder is defined as a persistent absence of sexual thoughts, fantasies, responsiveness and willingness to engage in sexual activity that causes personal or relationship distress and cannot be accounted for by another medical condition or substance.

Approximately one in three women in the United States suffers from low sexual desire and one in 10 women (16 million women total) are distressed by it.

Women describe the condition as if a switch had gone off. They don’t understand why they no longer want to have sex and find it troubling.

Multiple factors affect a woman’s ability, as well as her desire, to have sex, said Dr. Bitner. Chief among these is hormones—estrogen and testosterone—which fluctuate with her monthly cycle and life cycle (perimenopause, menopause) and directly affect brain chemicals related to sex drive.

“These are normal, natural physical reasons for a woman to feel low or no sexual desire. It’s not necessarily a medical problem,” she said. “Psychological and relational issues are often at play here, too. Women are much more affected by stressful life events, which influence the same hormones and brain chemicals related to her sexual function.”

Men, on the other hand, have a continuous surge in hormones and brain chemicals related to sex drive, rather than fluctuations, and tend to be less affected by as many life stressors.

The result: a slightly depressed, middle-age woman who has gained a few extra pounds, has parents in poor health, kids in trouble at school, an unrewarding job and little help around the house is not going to want sex. And a little pink pill probably won’t help.

The tale of flibanserin

Flibanserin has been clinically studied in more than 11,000 women with hypoactive sexual desire disorder. Those who took the drug reported modest improvements in sexual desire, an increase in satisfying sexual events and a decrease in distress over their lack of desire.

However, the American Psychiatric Association no longer lists the condition in its manual of mental health disorders.

“While the term may no longer be used in an official diagnostic context, the condition exists,” Dr. Bitner said. “It’s just been reclassified to combine low desire with low arousal in a broader diagnosis on the grounds that some women don’t feel desire until they’re aroused.”

And, the FDA has twice rejected the drug for approval, citing safety concerns like fainting and low blood pressure, and asking for more studies.

Some believed the FDA’s rejection was a sign of sexual bias or gender inequality. Although the FDA approved Viagra in 1998, and a host of products for men since, it has allowed nothing for women’s sexual function.

While the FDA admits this is an unmet medical need, it noted that only two drugs for women’s sexual dysfunction have come up for review in the past 16 years since Viagra was approved. Both were rejected as ineffective and unsafe.

A pro-flibanserin campaign, backed by Sprout and several women’s groups, launched to Even the Score. It parodied men’s erectile dysfunction drugs and asserted that ‘women have waited long enough’ and deserve equal consideration.

Is the little pink pill for you? Dr. Bitner shares 4 key things you need to know:

1. It’s not a ‘Viagra for women’

For men, drugs like Viagra affect the physical ability to have sex by increasing blood flow to the genitals. Basically, they bypass the ‘why’ (or ‘why not’) and go right to the ‘how’.

Disorders of women’s sexual desire have proven resistant to drugs that act on blood flow, hormones and other simple biological functions.

Addyi is designed to work on a woman’s biggest sexual organ: her brain.

The drug affects her desire for sex by altering the balance of brain chemicals. Specifically, it increases the neurotransmitters dopamine and norepinephrine, and decreases serotonin, in the brain’s prefrontal cortex.

And unlike Viagra, which is taken only at time of a sexual encounter, Addyi must be taken once a day and given four to six weeks to see an effect.

For women with physical issues that prevent them from having sex, like erectile dysfunction is for men, there are therapies that can help where flibanserin would not, said Dr. Bitner.

“Vaginal dryness, caused by low estrogen, creates pain during intercourse. Pain creates a negative feedback loop in the brain related to sex,” she said. “A local estrogen cream can be really helpful in promoting stronger, healthier vaginal tissue, eliminating pain and returning a positive association—and flow of brain chemicals—with sex.”

Dr. Bitner also recommends use of daily vaginal moisturizers and lubricants with sex.

“Look for moisturizers that contain hyaluronic acid to trap water into the skin. And coconut oil works great as a lubricant. It’s all natural, smells and tastes good, and is safe for both partners,” she said.

2. It can have serious, potentially dangerous, side effects

Addyi will come with a prominent warning about the risks of severe low blood pressure and fainting in women who drink alcohol while taking the drug. Other side effects may include sleepiness, dizziness and nausea.

Women who use certain antibiotics, antifungals and antidepressants, and those with liver impairments, should not take the drug.

“Women and their doctors will want to carefully consider health conditions and lifestyle factors when deciding if Addyi is a good choice for them,” Dr. Bitner said. “If a woman is on blood pressure medication, has liver or kidney issues, or likes to have a nightly cocktail, she may not be a good candidate.”

3. It has been approved for only certain women

Addyi is approved for women who have not gone through menopause and whose loss of sexual desire is not caused by disease or side effect of a drug.

It’s also widely known that antidepressants can have a side effect of decreasing libido. So can blood pressure medications. Will Addyi work for women who take these types of medications, or who are older than the mean age of women in the studies, which was 36 years?

“There are questions yet to be answered. Post-approval studies will likely be needed to further refine indications for the drug,” Dr. Bitner said. “This initial approval is for women whose physiology is on track and working well.”

Only prescribers and pharmacists certified through an online course will be able to prescribe and dispense the drug, which should be available as soon as October of this year.

4. There are other solutions for women with decreased libido

In addition to hormonal changes, either as the result of age or surgery, like a hysterectomy, decreased libido in women is most often related to depression, stress, fatigue, poor body image or self-esteem, prior bad sexual experiences or an unhealthy relationship.

“These libido-busters can be improved with hormone replacement, exercise, counseling and things that support a healthy relationship and a healthy self-image,” Dr. Bitner said. “Women who work out have a better sex drive, for example. It’s that link between exercise and dopamine, plus she feels good about herself physically.”

Other advice: remember the basics of a good relationship and prioritize time alone together. Do fun stuff together. Feel connected. Be playful. And, “initiate sex in the morning, when you feel well rested,” she said. “He’ll be ready to go.”

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