Experts are concerned that 'female viagra' may be used in favour of more helpful non-pharmacological interventions.
An additional one half of a satisfying sexual encounter is all women can look forward to when taking the long-awaited “female Viagra”, and women’s health experts are concerned that the pill may be used in favour of more helpful non-pharmacological interventions.
Not only were the benefits of flibanserin “marginal”, but women were significantly more likely to experience adverse events such as dizziness, nausea and fatigue, the researchers found.
“The conclusion that flibanserin is safe is premature,” the authors wrote after analysing five published, and three unpublished, studies on a total of 6000 women.
This finding has reignited questions about the US approval of the drug for Hypoactive Sexual Desire Disorder (HSDD), which was knocked back by the regulator twice before finally being given the green light last year.
“This new robust analysis of available studies highlights that that high quality evidence for effectiveness is lacking,” said Professor Deborah Bateson, medical director of Family Planning NSW.
The final approval came after a concerted marketing effort by the manufacturer, Sprout Pharmaceuticals, which framed the need for a green light in the context of women’s sexual rights.
“It does seem like there was not as much evidence as one might have hoped [prior to approval],” Professor Bateson said, noting the need for more research into older women with comorbidities or who have had surgical menopause.
Because the women in these studies generally already had a baseline of two to three satisfying sexual encounters per month, the impact of flibanserin may not be applicable to others with HSDD who have unknown, and possibly lower, sexual functioning.
Women taking flibanserin were twice as likely to drop out of the study due to adverse events than those on the placebo. Dizziness was four times higher, nausea was two and a half times higher and fatigue was 64% higher in the flibanserin group.
Another concern is that while serious side effects are rare, they are exacerbated in the presence of alcohol and the oral contraceptive pill.
“This highlights for me that for a great majority of women, this is probably not the answer,” said Professor Steve Robson, chair of the Women’s Health Committee and vice president of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists.
Flibanserin was developed for this indication because it was found to increase dopamine and noradrenaline, which increased the sexual response, and decreased serotonin, which was thought to inhibit it, Professor Robson said.
“But these are broad brush strokes to approach a lack of sexual interest in women,” he said.
Post-menopausal women were often in a situation that is very different to premenopausal women, and might be facing changes in their relationships, pressures at work or their partner not looking like Brad Pitt anymore, Professor Robson said.
People also underestimated the power of smell, touch and taste, which were all diminished by the reduced estrogen that women experienced after menopause, Professor Robson noted.
“I personally don’t know that taking a pill is going to alter that too much. A better investment is looking at how to make those other aspects of life better.”
Physical fitness, eating well and sorting out relationship issues were more likely to lead to better sexual experiences, and it would be an unusual patient that should be prescribed this pill first, he said.
“If it’s the choice between the pill and a nice dinner, I’d take the nice dinner,” Professor Robson said.
