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Take Pause: Newly Approved Pink Pill for Libido….Is It Truly a Female Viagra?

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The FDA has approved the first drug to treat women with low libido, but women’s health specialists are not celebrating.

The pink pill Addyi (pronounced add-ee) was rejected by the FDA twice due to lack of proven effectiveness. The FDA approval of Addyi this week is attributed to the influence of public organizations advocating gender equality in treatment of sexual disorders. While men have had many treatment options for their sexual problems, no treatment for female sexual disorders had been approved up until now.
The approval of Addyi is controversial. Some think that it does not measure up to accepted standards of benefit versus risk. Yet others support the decision of the FDA despite concerns about safety of the drug.

How does Addyi work?

Addyi is not a hormone. It balances chemicals in the brain that influence sexual feelings.
Some studies have shown that Addyi improves sexual function in woman and others have not shown that it is effective. In three recent studies, treatment with Addyi increased the number of satisfying sexual events by 0.5 to one additional event per month compared to women on a placebo pill. Across the three trials, about 10 percent more Addyi-treated patients than placebo-treated patients reported meaningful improvements in satisfying sexual events, sexual desire or distress.

Side Effects of Addyi

Side effects include dizziness, sleepiness, nausea, fatigue and dry mouth. A drop in blood pressure and fainting occurred in a small number of women in the study. Taking Addyi with alcohol increased the chance of low blood pressure and fainting.

Who should consider treatment with Addyi?

• Premenopausal women with lack of sexual desire that causes personal or relationship stress
• Women who are willing to avoid alcohol
• Women who do not take medications that can interact with Addyi

Because of the side effects, Addyi will only be available from certified health care professionals and certified pharmacies.