Exploring Flibanserin and Its Effects

Women’s sexuality is very complex, and is affected by brain chemistry, mood, relationships, medications, and health status (of both partners).

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Men have had over two dozen pills designed to treat sexual dysfunction. The drug is nicknamed Addyi and and it's the first to treat women with low or no desire. The nurses at Stanford's Gynecology Clinic have been busy fielding calls from patients wanting to know about what some are calling female Viagra. The little pink pill called Flibanserin is geared toward premenopausal women who have low libido. "This will be a historic moment for women," Leah Millheiser, M.D., said.

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Millheiser says one in 10 women suffer from what's known as hypoactive sexual desire disorder. She's a Stanford doctor who conducted landmark research in 2009, which found the brains of women with the disorder are different. She believes the new drug the FDA approved effectively targets the chemical imbalance. "Look the data speaks for itself, people doubled the amount of sexually satisfying events who were on the drug in the study," Millheiser said. The FDA advisory panel heard from women who want the pill and also received a letter of opposition signed by several health care advocacy groups, including San Francisco's Breast Cancer Action.

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"We're concerned that drug companies are trying to sell hope and hype," Breast Cancer Member Karuna Jaggar said. Jaggar says the data doesn't show the benefit outweighs the potential harm of the little pink pill. "This is a drug that you take every day, that stays in your blood stream, reduces blood pressure, increases the risk of fainting and interacts with common drugs such as alcohol, birth control and other pills," she said. The drug will carry a warning label and will not be advertised on radio or television for the next 18 months. The new drug's label will carry a bold warning that combining it with alcohol can cause dangerously low blood pressure and fainting. As a physician, if a woman comes to me reporting concerns with sexuality, I start by assessing her physical and mental health (depression is a common cause of loss of interest in sex), and then check to see if she is on medications that can affect interest in sex.

Common medication culprits are birth control pills, blood pressure pills, and antidepressants.

Is Addyi right for you?

If you’re interested in Addyi, ask your doctor if it’s an option for you. Discuss whether the benefits are worth the risks, Griesbach said. “The important point with hypoactive sexual desire is that non-medicine options should be considered first,” she said. She suggested lifestyle modifications, such as reducing stress and fatigue, increasing quality time with your partner and improving body image before using medicine to improve sexual desire. Your doctor also should rule out medical causes of low sexual desire.

The Evidence Is Underwhelming at Best

Addyi is anticipated to hit the market this fall, and a team of Marshfield Clinic pharmacists and doctors from across the system are evaluating the drug. “We review the effectiveness and safety of new medicines and assess where the medicine fits in the overall care of our patients,” Griesbach said. “We definitely plan on reviewing this medicine in the near future.” Doctors and pharmacists must undergo training before prescribing and dispensing the drug. It’s not yet known how much Addyi will cost or whether it will be covered by health insurance. Addyi, the first medication to treat low sex drive in women, already has a nickname: "Pink Viagra." Last week, the FDA approved the medication for treatment of Hypoactive Sexual Desire Disorder where patients' lack of sexual desire causes them personal distress.

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A few days after approval, Sprout Pharmaceuticals -- the company that makes Addyi -- was bought for a $1 billion. Dr. Alan Altman, of Aspen, was among those who worked to get the drug approved by the Food and Drug Administration. Altman specializes in treating sexual dysfunctions and is on Sprout Pharmaceuticals' board. SAN FRANCISCO (KGO) -- The Federal Drug Administration Tuesday approved the first prescription drug to boost sexual desire in women, a milestone long sought by the pharmaceutical industry. If all of those seem to be okay, I then check on her stress level and her schedule.

• Pink Viagra products sometimes come with misleading advertising claims.
• They often promise instant or dramatic sexual performance improvements.
• Many pink Viagra supplements have no clinical testing or approval.
• The trade name "Pink Viagra" is not an official pharmaceutical name.
• There are risks associated with counterfeit or substandard pink Viagra pills.
• Some users experience allergic reactions to unknown ingredients.
• The market for pink Viagra is flooded with low-quality or harmful products.
• Regulatory agencies detect and shut down illegal pink Viagra sales.
• Public awareness campaigns target unregulated sexual enhancement supplements.

Often, I find that couples who are struggling with sexuality have not set aside any time and energy for their relationship.

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Those problems can also occur if the drug is taken alongside certain common medications, including drugs used to treat yeast infections. The Food and Drug Administration approval on Tuesday marks an unusual turnaround for the agency. The FDA previously rejected the drug twice due to lackluster benefits and worrisome side effects. The Associated Press contributed to this story. Yahoo is part of the Yahoo family of brands.

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The Murders Before the Marathon

Just this past Tuesday, the FDA approved this drug for treatment of low sexual desire in women. Flibanserin has generated more questions, comments, and media inquiries for me than I’ve ever experienced in my 20-year career as an Ob/Gyn. While there are several medications that improve sexual function in men (including Viagra, the most famous one), flibanserin is the first drug ever approved by the FDA to improve sexual function in women. Here are what I consider the relevant facts and data about flibanserin, and the advice I give my patients. First of all, it’s not a “pink Viagra.” Viagra (sildenafil) treats erectile dysfunction in men by improving blood flow to the penis by inhibiting the enzyme nitric oxide synthase. I ask, “If you and your partner were alone on a tropical island, and you had no worries or schedules, would you be interested in sex?” If the answer is yes, we work on strategies for prioritizing and carving out time for the relationship. If the answer is no, then I am left with the diagnosis of hypoactive sexual desire disorder (also known as HSDD).

How does “female Viagra” work?

In contrast, flibanserin is thought to work by increasing the release of the neurotransmitter hormones dopamine and norepinephrine, while decreasing serotonin release in the area of the brain that regulates sexuality. Viagra is taken just before having sex, while flibanserin needs to be taken daily. Flibanserin is only approved for pre-menopausal women. It has been shown to slightly improve sexual satisfaction in some women (some more than others). The potential side effects include low blood pressure, nausea, and fainting. I often try to send these couples to sex therapists, but these experts are few and far between, and are often expensive.

In addition, many couples are too embarrassed to follow through.

This subgroup of women with hypoactive sexual desire has been vexing to me because I have largely not been able to help them.

Desire Starts in the Brain...

Women should not drink alcohol or use birth control pills while taking it because they can worsen the side effects. Of course, some women may decide these requirements and side effects are just not worth it, since they can be pretty big drawbacks for a drug designed to improve the sex lives of premenopausal women. In my practice, women of all ages have questions and concerns about sex and sexuality. Most women seeing an Ob/Gyn do. These questions often come up right after a woman has a baby, during perimenopause, and later in life as well. They are typically in healthy relationships, and yet they have no desire, sex drive, or response to sexuality.

• Pink Viagra is generally not recommended for women or non-binary individuals.
• Some products claim to improve female sexual arousal but lack evidence.
• FDA-approved medications for women include Flibanserin and Addyi.
• Pink Viagra labeled products are often unregulated for female use.
• Women should consult healthcare providers for safe options.
• Misuse of pink Viagra-type products can cause adverse effects in women.
• There is increased research into authorized female sexual enhancement drugs.
• Marketing claims about pink Viagra for women are often exaggerated.
• Reliable sexual health products should be prescribed or approved.

I try to explore all options with these women; however, to date, there has not been a medical option.