For the first time ever, the FDA has approved a libido drug for women. The little pink pill, Addyi (flibanserin), is being marketed by Sprout Pharmaceuticals as the drug that will bring gender equality to the field of sexual medicine.
The marketing of Addyi as a drug that will make women even in the field of sexual dysfunction is based on the claim that there are currently 26 approved sexual dysfunction drugs for men leaving women at a 26-time disadvantage. The FDA rejected this claim because there are no approved products for low sexual desire in men and most of the 26 drugs mentioned for men in the marketing material are different formulations of the same substance, testosterone. Furthermore, one tiny “blue pill” has dominated the male sexual dysfunction market for years, making Pfizer’s Viagra a $2 billion blockbuster drug.
So, will this new pink pill “even the score” for women in the area of sexual health?
Addyi is intended to increase sexual desire in pre-menopausal women by stimulating hormones in the brain that are related to sexual desire. But, the FDA rejected this miracle pink pill twice before approving it on August 19, 2015 noting that the side effects did not justify the benefits. For the most recent FDA review, no new efficacy data was presented.
According to Cindy Pearson, executive director of the National Women’s Health Network and long-time women’s health activist,
pushing drugs onto the market that are risky to women’s physical health is dangerous.
Ms. Pearson acknowledges that it would in fact be a victory in women’s sexual health to have a safe and effective libido drug, but, in her opinion, that has not happened yet (discussing the possibility of flibanserin getting FDA approval in June 2015)
Some of the lesser side effects of Addyi noted by the FDA while analyzing three clinical studies included fatigue, nausea, sleepiness, difficulty sleeping, dizziness and dry mouth.
On the other hand, the most troublesome risk with Addyi was not studied to the extent the other risks were studied. This is the risk of severe hypotension and loss of consciousness caused by a fall in blood pressure among patients who drink alcohol while taking the drug. The use of the word “patients” instead of “women” in this risk analysis is intentional. The clinical study that revealed the risk of combining Addyi and liquor was done on a mere 25 patients, only 2 of which were women. So, the actual risk posed by mixing alcohol and this daily libido drug was not extensively studied prior to the release of the drug. As a result, Addyi will carry a warning on the label for this risk, but the FDA Committee Meeting notes suggest that effective mitigation of this risk may require additional risk management strategies.
What about the benefits?
According to Thea Cacchioni, an assistant professor of women’s studies at the University of Victoria in British Columbia,
I don’t think there is anything sexist about denying approval for drugs that don’t have an adequate risk-to-benefit ratio.
Ms. Cacchioni wrote a book called “Big Pharma, Women, and the Labor of Love” prior to the approval of Abbyi.
Ms. Cacchioni is not alone in her criticism of the medicalization of female sexuality by Big Pharma. Critics like Leonore Tiefer, a psychologist at the New York University School of Medicine, say drugs like Addyi are trying to make low desire into a medical problem treatable by drugs when “most of these problems are psychological or relational.”
The marketing push for “Even The Score” resonated with at least some of the public – more than 60,000 people signed the petition that was presented to the FDA during the hearings. It remains to be seen if this manipulation of feminism will financially make “pink the new blue” in terms of financial gain for Sprout Pharmaceuticals. Addyi is exepected to sell for between $300 and $400 per month.