Taken from the September/October 2018 issue of the Women's Health Activist Newsletter.
Flibanserin (brand name “Addyi”) is the first drug approved by the Food and Drug Administration (FDA) to treat so-called “Hypoactive Sexual Desire Disorder” (HSDD) in premenopausal, heterosexual women. The drug’s not great, however, and its sales were terrible. So, the current owner1 is now investing heavily in a PR campaign to convince women the drug works and that they should order it from a new on-line prescription service. You may have seen the publicity campaign, which started earlier this summer.
Too many cultural forces tell women our sexuality’s about something other than our own pleasure. The NWHN is proudly pro-sex and believes that all people have the right to satisfying sexual experiences. So, you’d think we’d support medical efforts to help improve women’s libidos… but, we have significant problems with Addyi and fought against its approval for years.
The FDA rejected flibanserin twice: first in 2010, because it wasn’t shown to be more effective than a placebo, and then in 2013, due to safety concerns. The drug was finally approved in 2015, after a new manufacturer (Sprout) took it over and convinced the FDA to allow changes to the way Addyi’s effectiveness was measured. Under the new and more lax measurement, Addyi was deemed effective in about 10% of the women who used it; those women reported experiencing one more sexually satisfying event per month, on average, than they did before taking the drug (an increase from two to three events).
Ten percent’s not an impressive success rate. More troubling, in addition to not being very effective, Addyi has serious safety problems. During the drug’s clinical trial, twice as many women using flibanserin had accidents (including car accidents) compared to the control group. Turns out, taking Addyi while drinking alcohol causes dangerously low blood pressure and sudden loss of consciousness.
When it approved the drug in 2015, the FDA asked Sprout to study whether these dangerous complications resulted from women drinking alcohol while taking flibanserin. And, because of this concern, the agency added a warning label that women taking Addyi should completely avoid alcohol. (This means, essentially, not drinking at all; unlike Viagra, which affects genital blood flow and is taken before engaging in sexual activity, Addyi works on brain chemicals and must be taken every day).
The resulting study of alcohol use found that the combination of taking flibanserin and having two to four drinks (defined as 1.5 ounces of alcohol) caused unconsciousness and dangerous drops in blood pressure. That study was conducted on 23 men, and just 2 women, which makes very little sense, given that the drug is specifically designed for use by women. The study results are particularly problematic, since women absorb more alcohol in their blood when they drink the same amount as men, and so experience alcohol’s effects faster than men. As a result of the strange study design, women still lack clear information about Addyi’s risks and potentially harmful effects.
Recently, the drug manufacturer applied for approval in Canada and submitted the results of an alcohol safety study that actually involved women, which did not find the same risks from taking Addyi. But, this time around, the safety study excluded women with low blood pressure and limited women’s alcohol consumption to three 1.5 ounce drinks—different from the original study. And, those results have not been published, so we still don’t have complete information about the drug’s safety. Until we do, the NWHN recommends passing on the drug entirely. We recommend that women who do take Addyi heed the FDA’s warning and not drink any alcohol while doing so.
Health advocates know that women’s libidos can decline for a host of reasons, and that there are other options to help improve sexual satisfaction. We think there are better alternatives for addressing low libido than taking an ineffective and dangerous drug with unknown safety risks. Non-drug approaches: seeing a sex therapist, experimenting with sex toys, changing the dose or type of medicines that are known to reduce libido (like antidepressants and high blood pressure medication), and addressing relationship and/or personal stressors are all potential options that have worked for some people.
In much the same way that we lack information about Addyi, we also need more information about women and desire in general. The list of things we don’t know about women’s libido is long and includes the prevalence and causes of low libido, experiences of lesbian and bisexual women compared to heterosexual women, and the effectiveness of non-medical approaches to enhancing libido vs. taking a drug. The NWHN will keep advocating for research on these and other questions about women’s health, as well as for approval of safe and effective drugs.
Abby Miller was the NWHN Communications intern over the summer of 2018.
Susan K. Flinn is the NHWN newsletter editor.