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Q: Let’s get this straight: There’s a Viagra for women now?
A: Not quite. The FDA approved a drug named Addyi (flibanserin) to treat low libido in premenopausal women, but it’s not exactly like the blue pill. Anticipated to debut October 17, the new medication is intended for women with generalized hypoactive sexual desire disorder (HSDD). This disorder is characterized by sexual desire so low that it causes distress or interpersonal difficulty, but isn’t a result of co-existing conditions or other medications.
Q: So, how exactly is Addyi different from Viagra?
A: There are three major differences. First, the 100 mg bedtime dose of Addyi (more about why it’s administered at bedtime soon) is taken daily and works over the long run. The effects of Addyi take about four weeks to appear and eight weeks to peak. Men take Viagra for immediate results.
Second, Addyi works differently from Viagra. Viagra increases blood flow to the *****, while Addyi influences neurotransmitters in the brain to increase sexual pleasure. It works similarly to an antidepressant, increasing levels of mood-regulators dopamine and norepinephrine, rather than affecting blood vessels in the ******* area. *** drugs for men help achieve erections or treat testosterone deficiencies, rather than increasing desire.
Finally, Addyi has a lower success rate than Viagra, which works for nearly 100 percent of men. Addyi benefits one in 10 women. The pill will cost about the same as a monthly allotment of Viagra—about $400. It’s still unclear if insurance companies will pay for it.
Q: Why is it so controversial?
A: The demand for a drug to treat low libido in women is rooted in social debate. Lobbyers accuse the FDA of gender bias: The organization has approved 23 treatments for sexual dysfunction in men and none for women. (The condition is more common in women than in men: 43 percent versus 31 percent.)
In fact, the FDA already rejected Addyi—twice. The agency questioned the drug’s effectiveness, especially given its serious side effects (more on that below). But this time, Addyi manufacturer Sprout Pharmaceuticals teamed with a PR campaign named “Even the Score.” The campaign’s message: Women miss out when it comes to treatment for sexual health. The group brought 20 women to the FDA to provide testimony about how sexual dysfunction affects their lives.
The drug was approved. For supporters, it’s a milestone in women’s health.
But the drug is indisputably risky. It raises the question: Is lack of sexual health drugs for women really a case of gender discrimination? Or is women’s sexual health more complicated than men’s? The National Women’s Health Network, a consumer activist group, wrote a letter to the FDA pressing that the problem is not gender bias, but the dangers of the drug itself. Addyi comes with a black box warning, the strictest warning on prescription drug labels, designed to call attention to life-threatening risks. The drug may induce unpredictable fainting, particularly dangerous if a patient is driving—which is the reason it’s taken at bedtime. It can also cause extremely low blood pressure, nausea, dizziness, and sleepiness.
Another caveat: The FDA states that Addyi shouldn’t be taken with ******* (it increases the risk of severely low blood pressure and fainting). That requires complete sobriety while taking the daily pill. Physicians must undergo special training, pass a test about the risks of the Addyi, and assess the likelihood of a patient reliably staying sober before prescribing it.
Q: How effective is Addyi?
A: In a clinical trial of 2,400 women with generalized HSDD (average age 36), those who took the drug reported 4.5 sexually satisfying events per month, including manual ***, oral ***, or ********tion, with or without orgasm. At baseline levels, the women had an average of 2.7 satisfying sexual events per month. Those who took a placebo experienced 3.7 events. About 10 percent of women benefited from Addyi. Some experts question if the pill is only a slight aphrodisiac with frightening side effects. Others point out that about 16 million U.S. women are affected by low sexual desire, meaning a 10 percent success rate could still benefit 1.6 million women. The FDA urges women to stop taking the drug if they don’t see effects after eight weeks.
Q: Hmm… Is it worth giving it a try?
A: Your doctor can best answer that. He or she will evaluate your overall health before making any prescriptions. Not sure yet? Consider giving these You do not have permission to view the full content of this post. Log in or register now. a shot
