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.
I’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:
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.
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.