Female Drug Fails to Deliver What It Promotes

By Dr. Mercola

In August 2015, the U.S. Food and Drug Administration (FDA) approved Addyi (flibanserin), the first drug to treat low libido in women. It's estimated that nearly 27 percent of premenopausal women and more than 52 percent of postmenopausal women experience low sexual desire.¹

Addyi is specifically approved to treat generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. According to the FDA:²

"HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance.

HSDD is acquired when it develops in a patient who previously had no problems with sexual desire. HSDD is generalized when it occurs regardless of the type of sexual activity, the situation or the sexual partner."

There were red flags associated with Addyi's approval from the beginning. Not only did it display worrying side effects, but clinical trials showed the drug only increased the number of satisfying sexual events by about one per month, an effectiveness rate that led critics to argue against the drug's use.

Now new research once again shows that Addyi may be hardly effective at all, coupled with a host of serious side effects that make the pill not nearly worth the risk.

Female Viagra: Marginal Benefit, Serious Risks

A systematic review and meta-analysis of eight studies revealed treatment with Addyi resulted in just one-half additional satisfying sexual event per month.³ For that marginal benefit, the women were flooded with adverse events, including a significantly increased risk of:

• Dizziness
• Somnolence
• Nausea
• Fatigue

The risk of dizziness among women taking the drug, dubbed "female Viagra," was quadrupled while the risk of nausea was more than doubled. Overall, about 1 in 3 women taking Addyi experienced side effects.

Addyi is a serotonin 1A receptor agonist and a serotonin 2A receptor antagonist that works by affecting brain receptors. However, the FDA noted "the mechanism by which the drug improves sexual desire and related distress is not known."⁴

The drug was only approved after three FDA reviews and two agency advisory committee meetings, but even then the FDA's own clinical reviewers rejected Addyi.

Dr. Steven Woloshin, a professor of Medicine at the Dartmouth Institute for Health Policy and Clinical Practice in New Hampshire, who wrote an editorial accompanying the study, said the FDA "caved to public pressure from a manufacturer-sponsored advocacy campaign alleging that sexism had held up the drug's approval."⁵

He told Medscape, "All of the clinical reviewers, the people closest to the data, voted to reject the drug, but they were overruled by the senior administrative people."⁶

Addyi Is Dangerous When Taken With Alcohol

Addyi, which is a once-daily pill, comes with a black-box warning that consuming the drug with alcohol may lead to severely low blood pressure and fainting. Taking the drug along with certain medications or if you have liver problems may also be dangerous. The FDA reported:⁷

"Addyi can cause severely low blood pressure (hypotension) and loss of consciousness (syncope).

These risks are increased and more severe when patients drink alcohol or take Addyi with certain medicines (known as moderate or strong CYP3A4 inhibitors) that interfere with the breakdown of Addyi in the body.

Because of the alcohol interaction, the use of alcohol is contraindicated while taking Addyi. Health care professionals must assess the likelihood of the patient reliably abstaining from alcohol before prescribing Addyi."

Further, when the drug was approved it was only done so with conditions — a risk evaluation and mitigation strategy (REMS).

In addition to the black-box warning and the requirement that Addyi only be dispensed by certified prescribers and pharmacies, the FDA has required three studies to be conducted to explore the risks of taking Addyi along with alcohol.

Female Viagra Tanks on the Market

Addyi was developed by Sprout Pharmaceuticals, but within 48 hours of the drug's FDA approval, Valeant Pharmaceuticals purchased Sprout Pharmaceuticals for about $1 billion.⁸

They were likely expecting Addyi to be a top seller, and in 2015 Valeant was hoping to reach sales of between $100 million and $150 million.

Sales, however, have fallen far short, at just $11 million a year. As of January 2015, only about 240 to 290 prescriptions were being sold each week, The New York Times reported.⁹

Indeed, taking a pill every day to possibly experience one-half additional pleasurable sexual encounter a month, along with dizziness, fatigue and nausea, hardly seems like a good trade off for women.

People are right to be wary of this drug, especially since it does nothing to address the underlying factors leading to low libido.

Addyi is not meant for long-term use, and the FDA reports "patients should discontinue treatment after eight weeks if they do not report an improvement in sexual desire and associated distress."¹⁰ Even if the pill boosted your libido, any gain will disappear once you stop taking the drug.

What Causes Low Libido in Women?

The reasons for low libido are complex and run the gamut from stress and other emotional difficulties to physical problems, including erectile dysfunction.

Most people do not seek help for chronic low libido, which is unfortunate because regular sex with a committed partner cannot be underestimated as a factor for reducing stress, bolstering self-esteem, and fostering feelings of intimacy and bonding between partners.

A healthy sex life can provide for a longer, healthier and, most would agree, more enjoyable life, but many are missing out on this very primal pleasure.

There are many similarities between men and women in regard to desire; contrary to popular belief. For example, visual images trigger sexual desire in both sexes.

Likewise, anxiety, defensiveness, fear, and failure of communication are destructive psychological forces that can take a heavy toll on your libido, whether you're a man or a woman, by acting as roadblocks to desire. So addressing emotional issues should be a primary goal.

Low Testosterone May Be to Blame for Low Libido in Women

Hormonal issues may also be to blame for low libido in women, particularly low testosterone levels. Testosterone is normally produced in small amounts by the ovaries and adrenal glands in premenopausal women.

But during menopause, the ovaries' production of hormones, including testosterone, decreases. Some researchers believe that this decrease in testosterone affects sex drive in postmenopausal women. Decreased sex drive is one symptom of low testosterone in women, as are the following:

• Weight gain
• Fatigue and exhaustion
• Mood swings
• Depression or anxiety
• Hair loss

If your testosterone levels are low, treatment with bioidentical testosterone may significantly boost your libido. According to research published in Therapeutic Advances in Endocrinology and Metabolism:¹¹

"Modest benefit has been shown from transdermal testosterone therapy given to postmenopausal women with reduced sexual desire.

An increased frequency of satisfying sexual encounters and intensity of sexual desire and response has been shown in medically and psychiatrically healthy women able to have 2 to 3 satisfying sexual experiences each month before therapy commences."

Women, Nine Tips to Boost Your Sex Drive Naturally (They Work for Men Too)

To boost your libido naturally and help restore harmony to your intimate life, try the strategies that follow.

1. Reduce, with the plan of eliminating, grains and sugars in your diet. It is vitally important to eliminate sugars, especially fructose. High levels of sugar in your bloodstream can actually turn off the gene that controls your sex hormones.¹²
2. Eat a healthy diet, like the one described in my nutrition plan, which will help to normalize your insulin levels. This simple measure has a profound influence on every area of your health, including your sex life.
3. Optimize your vitamin D levels, ideally through appropriate sun exposure as vitamin D levels increase testosterone levels, which may boost libido.
4. Exercise regularly. Make sure you incorporate high-intensity interval training exercises, which also optimize your human growth hormone (HGH) production.
5. Avoid smoking or drinking alcohol excessively.
6. Be sure to get plenty of high-quality, restorative sleep.
7. Consider choline and vitamin B5 supplements.The neurotransmitter that triggers the sexual message, in both men and women, is acetylcholine (ACH). With too little ACH, sexual activity goes down. One way to safely and effectively enhance ACH levels in your body is to take choline supplements (1,000 to 3,000 mg) and vitamin B5 (500 to 1,500 mg).
8. Stress can dampen your libido and make sex the last thing on your mind. Taking control of your emotions by learning the Emotional Freedom Techniques (EFT) can really help in this area to re-ignite your sex life.

EFT is a psychological acupressure technique that can help you effectively address your stress-related thoughts and leave you feeling calmer and more able to face your challenges, whatever they may be, so you're able to focus on more enjoyable pursuits.

9. Try maca root. Maca, a rainforest herb, has been used for centuries as a libido booster, and it's also used to relieve menopausal symptoms in women. Research shows maca root may alleviate antidepressant induced sexual dysfunction in postmenopausal women, and the herb was well tolerated with few side effects.¹³