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Advise Against Flibanserin

Fugh-Berman, Adriane MD

AJN, American Journal of Nursing: March 2016 - Volume 116 - Issue 3 - p 13
doi: 10.1097/01.NAJ.0000481261.79494.31
Letters

Adriane Fugh-Berman, MD

Washington, DC

In Drug Watch, Diane Aschenbrenner offers a thorough discussion of flibanserin (Addyi) and its pharmacology (“The First Drug for Hypoactive Sexual Desire Disorder in Women,” December 2015). Below is additional context that I hope will cause nurses to actively recommend against the use of flibanserin.

First of all, hypoactive sexual desire disorder (HSDD), the condition flibanserin was approved for, was invented by pharmaceutical companies.1, 2 Certainly, some women are troubled by low libido, but it's not caused by a brain dysfunction. Sexual desire waxes and wanes because of a variety of factors, including stress, boredom, children, relationship issues, and normal aging. And let's not forget medications: oral contraception, antidepressants, antihypertensives, and other drugs can all lower libido.

Disparities in libido are common in relationships, can be problematic, and are best dealt with through psychosexual counseling. It's chilling that the labeled indication for flibanserin describes generalized HSDD as being “characterized by low sexual desire that causes marked distress or interpersonal difficulty.”3 So, if the patient herself isn't distressed, she is still eligible for on-label treatment if low sexual desire leads to “interpersonal difficulty.” Flibanserin may be the first drug approved to treat marital discord.

Flibanserin isn't very effective—it increased “satisfying sexual events” by about one event per month.3 This event, by the way, need not include an orgasm or partner. Women in flibanserin studies were already having about three satisfying sexual events per month at baseline.

Besides being ineffective in many women, flibanserin is a dangerous drug. As Aschenbrenner discusses, the Food and Drug Administration requested that Sprout Pharmaceuticals, the maker of flibanserin, perform an alcohol interaction study. The study included 23 men and two women, an absurdity for a drug intended only for use by women, who are more susceptible to alcohol's effects than men.

Not that the men avoided adverse effects3: four (17%) of the participants who mixed the now-approved 100-mg dose of flibanserin with the equivalent of two drinks experienced hypotension or syncope. Their systolic blood pressure levels dropped by up to 54 mmHg; diastolic blood pressure levels dropped by up to 46 mmHg.3 A quarter of the subjects (six out of 24) who took 100 mg of flibanserin with the equivalent of four drinks experienced orthostatic hypotension. Even without alcohol, flibanserin can cause severe drops in blood pressure levels and sudden prolonged unconsciousness.

The harms associated with flibanserin might be acceptable in a cancer drug, but they are entirely unacceptable in a drug given to healthy women for an invented condition. It's up to us to protect our patients by not recommending the use of flibanserin.

Adriane Fugh-Berman, MD

Washington, DC

Editor's note: Dr. Fugh-Berman directs PharmedOut, a research and education project that promotes rational prescribing. She is a paid expert witness in litigation regarding pharmaceutical marketing practices.

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REFERENCES

1. Moynihan R, Mintzer B. Sex, lies, and pharmaceuticals: how drug companies plan to profit from female sexual dysfunction. Sydney, NSW, Australia: Allen and Unwin Pty Ltd; 2010.
2. Meixel A, et al. Hypoactive sexual desire disorder: inventing a disease to sell low libido J Med Ethics. 2015;41(10):859–62
3. Addyi [package insert]. Raleigh, NC: Sprout Pharmaceuticals; 2015.
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