A new review of the "little pink pill" for women with low sexual desire says the drug doesn't work very well -- but some doctors and patients who've been using the treatment disagree. The drug, Addyi, or flibanserin, has been on the market since October.
"The data presented in this review suggests that the meaningful change caused by flibanserin is minimal," according to the team of Dutch researchers.
The researchers looked at eight studies on Addyi that together included nearly 6,000 women. They said for women using the drug, the number of additional "satisfying sexual events" averaged out to about 0.5 per month.
The agency asked Sprout Pharmaceuticals, which makes Addyi, to do more studies on the interaction between Addyi and alcohol.
An editorial accompanying the article, published in JAMA Internal Medicine, questioned the FDA's approval of the drug. "The FDA approved a marginally effective drug for a non-life-threatening condition in the face of substantial -- and unnecessary -- uncertainty about its dangers," wrote Dr. Steven Woloshin and Dr. Lisa Schwartz at the Center for Medicine and the Media at the Dartmouth Institute for Health Policy and Clinical Practice.
The researchers said the drug had significant known side effects, such as dizziness, sleepiness, and nausea.
The FDA approved Addyi last August with a "black box warning" to highlight the risks of severe low blood pressure and fainting when patients drink alcohol, take certain drugs, or have liver problems.
'I was amazed'
Some doctors and patients who've been using Addyi say the drug has been helpful. There are no other FDA-approved treatments for women suffering from low sexual desire.
Dr. Lauren Streicher, medical director of the Center for Sexual Medicine at Northwestern Memorial Hospital in Chicago, said the results cited in the Dutch study are averages, and while Addyi doesn't work for everyone, many of her patients have benefited from it.
She says she's written Addyi prescriptions for about 10 women, and three or four have emailed her back to say it's worked. "They say, 'Oh my God, this has changed my life. Things are wonderful,'" Streicher said.
Jodi Cole, a 33-year-old stay-at-home mother from Porter, Oklahoma, said before she started taking Addyi, she didn't want to have sex with her husband, Matt. "I love my husband and I believe God created emotional and sexual intimacy as key components of marriage. So we had sex, usually a couple of times a week. And while I was willing, part of me dreaded it. Every time," Cole wrote in an email to CNN.
Cole said she started taking Addyi in November, and within six weeks felt a difference. "I was amazed," she wrote. "I actually enjoyed being intimate and for the first time in a long time felt that connection with Matt."
She said for her it wasn't about increasing the quantity of sex she was having, but rather the quality. "What (Addyi) does is give just enough support so I can think about that part of our relationship with anticipation of pleasure rather than anxiety," she wrote. She understands Addyi can have side effects, but said women should be able to choose to take it just as men choose to take Viagra despite its side effects.
"I should be able to choose whether the side effects are worth the benefit," she wrote.
Source: CNN
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