From 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.