Flibanserin, the drug for hypoactive sexual desire disorder in women (a condition that many argue doesn’t exist as for many women sexual desire is responsive, not spontaneous) has been approved by the FDA and will be sold under the brand name Addyi.

AddyiI’m underwhelmed and concerned about flibanserin for a variety of reasons, but I want to focus on one very specific and important point about the drug that appears in the REMS (Risk Evaluation and Mitigation Strategy) required by the FDA. For those of you who may not know REMS is required by the FDA for certain drugs that have a greater risk of serious complications. Some drugs require an 8 hour training course, but with Addyi all a doctor has to do is read 12 Power Point slides, answer a couple of questions, and submit a form – truly as Sprout says “3 Easy Steps.” Because yes, you want your provider’s training to be easy not thorough!

The REMS did not mention how to screen, or limiting prescribing for 8 weeks to assess efficacy, or interactions with other drugs.  It took me less than 5 minutes to complete and the gist was,

  • Don’t mix Addyi with alcohol
  • Your patient must promise to not drink alcohol ever on Addyi
  • You know this medication is dangerous if mixed with alcohol?
  • It is your responsibility to make sure your patient doesn’t mix this medication with alcohol.

The REMS mentions what happens when the drug was taken with alcohol in 25 healthy volunteers (mostly men) – a significant drop in blood pressure in 42% who had the equivalent of 2-4 glasses of wine. Most of the study subjects were men, so I can only assume that this could even be higher/more severe for women. Just remember, the SAFETY of Addyi with alcohol was studied in 23 men and 2 women, for a drug ONLY to be prescribed for women. I mean it’s not like men and women react differently to alcohol or anything. Sigh. Regardless, some of the healthy test volunteers, most of whom were men, needed treatment for their dangerous drop in blood pressure from taking Addyi with alcohol.

Here is the black box warning about alcohol:

black box

And to emphasize the no alcohol at all here are two of the lip service training slides:



Here is a summary of Addyi:

It must be taken every day.

9-14% of women respond to it.

Responding means an increase of 0.5-0.7 sexually satisfying events per month.

If you think Addyi is something you want to try make sure you have no pain with sex (a cause of decreased libido), are not taking medications that can affect sexual response (e.g. many antidepressants), don’t have untreated depression (a cause of sexual disinterest) and that you are getting enough emotional intimacy in your relationship because for many women that is the necessary step for sexual desire. If you decide to take Addyi and you have not felt a change in 8 weeks, stop taking it.

And don’t drink any alcohol. At all.



Join the Conversation


  1. I wonder how they assessed an increase of 0.5 sexually satisfying events per month? Half of an event? Half of an orgasm? Sheeeesh…..

    Not much has changed about flibanserin concerns since I wrote this in 2009: http://ethicalnag.org/2009/11/15/boehringer-desire-drug/ I do however like the sexual satisfaction survey results, reported in the hilarious housework-helping ‘Porn For Women’ from the Cambridge Women’s Pornography Collective, who asked women the eternal question: “What really, really gets you hot?”

  2. Once again, I’m so glad you exist, doctor, and post such accessible material about women’s health. Thank you.

  3. I’m surprised it got approved. Must’ve had some very powerful lobbyists, because it was rejected by the FDA twice before. From what I’ve heard about it so far, I think it should’ve stayed that way.

  4. I shall confine myself to the area which you have commented on: I won’t say anything about the FDA under pressure to approve a ‘gender equivalent’ drug for women, a ‘female viagra’ (which it certainly isn’t); nor the dubious pressure groups approaching the FDA; nor a drug with minimal effects for a condition that (probably) doesn’t exist—though it does join a long list of glorious if useless drugs in search of an application.

    I hadn’t realised that the side effects had been observed in men. (What next: new contraceptive pills/morning after pills being tested in men? Drugs for prostatic cancer being tested in women?)

    As for the booze; well, doctor, if the patient even sniffs a Martini it’s your fault. Personally, I’d suggest the co-payments would be better spent on “I am Jill’s clitoris 101” and a romantic candlelit dinner with a bottle of fizz.

  5. New to this area of medicine (I’m a cardiac electrophysiologist), but detecting BS can be speciality independent. This smelled like BS ever before I read this great post.

    If doctors prescribe honestly, this is gonna be a really small market. Alcohol-free women with either great insurance or lots of money who strongly desire sex, with no secondary causes for reduction in libido. They’ve got to be willing to take it every day with no likely effect for a month or so. Good luck finding that woman.

    Just saw this abstract on bupropion. http://www.ncbi.nlm.nih.gov/pubmed/20151970 Looks like an efficacious alternative without the cost and alcohol issues. It’s off-label, so it can’t be promoted, but that isn’t an issue for the MD. Jen, do you prescribe bupropion for HSDD? Is this a viable drug option?


  6. Dear Dr. Jen;
    Thank you. This drug is frightening. What is even more frightening is that the FDA even allowed it. I have instructed all of my loved ones to take NOTHING without either one of us, my husband or I (OK, we are not MDs, but bio-med folks that have access to research studies, know how to read the data and assess results) until we have done so and if need be have asked our Pharmaco-kinetic pals, drug development experts, researchers, etc, to help us out. So thank you. This drug makes me angry. Guess who will be taking it?

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