Q&A on the Female Libido Drug

Last week, the FDA approved the first prescription drug aimed at boosting women’s libido. The process of approval was controversial, as we wrote recently in our blog, “An ‘Astroturf’ Grassroots Campaign for a Female Viagra.”

The reference to the fake grass came from a commentator writing on HealthNewsReview.org, (HNR) whose point, with which we agree, was that people who testified before the FDA panel considering the approval were manufactured witnesses, not scientists. They were political and commercial activists whose efforts HNR called “faux-advocacy.” Their slick presentations snookered the FDA into supporting the idea that women with a low sexual drive should be considered sick and that they suffer discrimination because men have drugs to aid their sexual needs, but not women.

Keep in mind that approval of the drug was denied twice previously because of concerns about the drug’s safety and its negligible benefits.

The pill, whose brand name is Addyi, will be available as of October accompanied by warnings about the risk of dangerously low blood pressure, and fainting, if you drink alcohol while taking it. It’s approved only for younger, premenopausal women, but doctors can prescribe it “off-label” to older women, even though its effects haven’t been studied in them.

The Associated Press (AP) offered a Q&A to help readers understand the drug. Following is an excerpt of its story. But if you want to understand in more depth why Addyi is so controversial and why you might want to avoid it, read the thoughtful discussion that aired on the PBS NewsHour under the heading “Why Some Doctors Are Wary of the New Female Libido Pill.”

Q: How does Addyi work?

A: It acts on brain chemicals associated with mood and appetite, similar to antidepressant drugs, and originally was studied as a treatment for depression before being repurposed into a libido drug. Researchers note its ability to increase dopamine, a brain chemical associated with appetite, while lowering serotonin, which is linked with feelings of satiation.

Q: Who is this drug intended for?

A: The FDA approved it for premenopausal women with hypoactive sexual desire disorder (HSDD), described as a lack of sexual appetite that causes emotional distress. As many as 8.6 million U.S. women might have the condition, but because so many other factors affect sexual appetite, other causes for sexual disinterest must be ruled out before a diagnosis can be made. Relationship problems, medical conditions and mood issues caused by other medications all can affect libido.

And the diagnosis is not universally accepted; many experts say that low sex drive should not be considered a medical condition.

Q: Why is the approval decision controversial?

A: The process was contentious, including two previous rejections by the FDA. Drug manufacturers and some medical experts claim that women need prescription medications to treat sexual disorders, which they consider serious medical problems. Some experts and consumer-safety advocates claim that the drug’s side effects are dangerous, and some question whether low libido is a medical condition. Tactics for approval by the manufacturer, Sprout Pharmaceuticals, have been challenged for enlisting outside politicians and women’s groups to lobby the feds.

Q: Does the drug work?

A: Experts usually describe Addyi’s effect as “modest.” Sprout’s studies showed that women taking the drug reported a slight increase in sexually satisfying events each month, and they reported a slight increase in desire and a slight decrease in stress.

FDA scientists described these effects as “small,” but enough to meet its effectiveness standards.

Q: What are the side effects?

A: About 1 in 10 patients in Sprout’s studies experienced the most common problems: dizziness, fatigue and nausea. The drug will carry a warning label that women should not drink alcohol or take certain types of other medications, including antifungal drugs, because those combinations can cause low blood pressure and fainting.

Q: How much will it cost?

A: Women with health insurance will pay between $30 and $75 for a month’s supply of Addyi, depending on their coverage.

Q: Why did the FDA approve the drug this time?

A: Regulators first rejected Addyi in 2010, saying that it failed to achieve a key study goal – increasing desire based on patients’ daily journal entries. That deficiency, combined with the drug’s negative side effects, outweighed its benefits.

Sprout conducted another study of sexual desire using a different method whose results the FDA found acceptable. The company also conducted safety studies to clarify the drug’s risks, which are outlined on its warning label.

“While the FDA is required to make all decisions based on science,” according to AP, “critics say that the concerted lobbying effort by Sprout-funded supporters also played a role in Addyi’s approval.”

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