Alcohol Safety of New 'Female Viagra' Was Tested Almost Entirely on Men

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Alcohol Safety of New 'Female Viagra' Was Tested Almost Entirely on Men

By May Wilkerson 08/31/15

What's the point of testing the safety of a drug for women on men?

Image: 
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Everyone’s buzzing about Addyi, the first-ever “female viagra.” The medication for low-libido in women was recently approved by the FDA and is set to hit the market in mid-October. But there’s a catch.

According to medical professionals, people who take Addyi must abstain from drinking entirely. Alcohol is thought to exacerbate the drug’s side effects, which may include fainting, dizziness, and low blood pressure.

However, there’s actually no proof that women who take Addyi are putting their health at risk by drinking a boozy beverage or two. This is because the research into the safety of mixing alcohol and Addyi was almost entirely conducted on men; there were 23 men and a total of two women in the study.

Dr. Jen Gunter, an OB/GYN in the Bay Area, first picked up on this when she was researching the risks of of Addyi over the weekend. “If you have a drug that’s only for women, there’s no point in testing it on men,” she said. “I just don’t see how safety data on 23 men is relevant.”

She said the lack of women in the study is particularly problematic in this case, since patients may underestimate the severity of the anti-alcohol warning. Unlike with other medications, where patients are “recommended” not to drink while taking them, the risks of mixing booze with Addyi could be more serious, especially for women.

“Gender differences in the metabolism and toxicity of alcohol are well known, and women are more susceptible to toxicity effects than are men,” said Lori Brotto, a sex researcher at the University of British Columbia. “As such, I think the negative interactions between Addyi and alcohol found in the safety study are understated, and in women taking Addyi, I would expect the mixing to be more devastating.”

Cindy Whitehead, the CEO for Sprout Pharmaceuticals, the company manufacturing Addyi, told Science of Us that the study required participants to take two to four shots of grain alcohol within 10 minutes in the morning, and then take a dose of a non-brand version of the drug. Many of the participants experienced fainting and dangerously low blood pressure levels, and some needed medical intervention, resulting in the alcohol restriction.

Whitehead claims that the gender disparity occurred because many more men than women were willing to consume that amount of alcohol that quickly first thing in the morning. She also said that the company does plan to conduct more Addyi experiments, both involving women and more closely mimicking realistic drinking scenarios.

Under-representation of women in biomedical research is nothing new, and one reason often cited is that women’s menstrual cycles or potential pregnancies can disrupt data. There may be some logic to this, but less so in the case of a drug like Addyi that is intended primarily for women.

The drug may or may not be a big seller, since early tests found that its effects on the female libido were moderate at best. If the dangers of combining it with alcohol are actually as severe for women as predicted, this could also significantly reduce sales.

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