A lot has been published and broadcast about the new drug’s potential benefits to improve sex drive, as well as its side effects.
It’s been about a month since the U.S. Food and Drug Administration (FDA) approved Addyi (flibanserin), the first prescription drug for treating hypoactive sexual desire disorder (HSDD) in premenopausal women. Since then a lot has been published and broadcast about the new drug’s potential benefits to improve sex drive, as well as its side effects.
What is HSDD? According to the FDA’s website, “HSDD is a serious and long-recognized disorder with impacts far beyond the bedroom, affecting relationships, self-confidence and self-image. HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance.”
Some have referred to Addyi as the “female Viagra,” but that is a misnomer. Viagra, an erectile dysfunction drug for men, is taken 30 to 60 minutes before sexual intercourse to increase blood flow to the penis. Addyi is taken daily at bedtime. Although it is not known exactly how Addyi increases sexual desire in women, it is thought to work by increasing dopamine and norepinephrine activity and reducing serotonin activity in the central nervous system.
In clinical trials, women taking Addyi experienced 0.5 to 1 more “satisfying sexual event” per month. That is far from a resounding success, especially considering the risks associated with the drug.
Addyi – also known as the “little pink pill” – has potentially serious side effects, principally low blood pressure and loss of consciousness. These risks are increased and more severe when patients drink alcohol or take Addyi with certain other medications.
“Low blood pressure and loss of consciousness obviously should be taken very seriously,” said Lyndsey Neese, M.D., an OB/GYN with Norton Women’s Specialists. “And you cannot take Addyi if you are ever going to drink alcohol.”
Health care professionals who prescribe Addyi and pharmacies that dispense Addyi must be certified by the Addyi risk evaluation and mitigation strategies (REMS) program and must counsel patients about the risks.
So why did the FDA approve a drug that has seemingly low effectiveness and can cause serious side effects?
According to its website, the FDA has recognized for some time the challenges involved in developing treatments for female sexual dysfunction. The FDA held a public patient-focused drug development meeting and scientific workshop on female sexual dysfunction in October 2014 to solicit perspectives directly from patients about their condition and its impact on daily life, and to discuss the scientific challenges related to developing drugs to treat these disorders. The FDA continues to encourage drug development in this area.
If you would like more information about Addyi or believe you may have hypoactive sexual desire disorder, speak with your OB/GYN. Need an OB/GYN? Norton Healthcare can help you find one.