do not have an underlying physical or psychological cause for the disorder, the agency said in a news release.
Marketed by Raleigh, N.C.-based Sprout Pharmaceuticals, Addyi’s label will warn that it can cause blood pressure to drop severely and may lead to loss of consciousness. These risks increase and symptoms may become worse when alcohol is consumed. So, Addyi users are warned to not to drink any alcohol, the FDA said.
Doctors who prescribe the drug and any pharmacy that dispenses it must be certified, the agency said. Pharmacies must warn users of the risks of drinking alcohol while on the medication.
People who take the once-daily drug should discontinue use after eight weeks if there’s no improvement in sexual desire, the FDA added. Addyi was evaluated in clinical studies involving some 2,400 premenopausal women. Users of Addyi reported a significant increase in sexual desire, compared to those who took a placebo.
The most common adverse reactions included dizziness, sleepiness, nausea, fatigue, insomnia and dry mouth. The agency said it encouraged women who used the drug to report any side effects to its Adverse Event Reporting Program at www.fda.gov/MedWatch.
Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women. Addyi is a serotonin 1A receptor agonist and a serotonin 2A receptor antagonist, but the mechanism by which the drug improves sexual desire and related distress is not known.
Addyi is taken once daily. It is dosed at bedtime to help decrease the risk of adverse events occurring due to possible hypotension, syncope and central nervous system depression (such as sleepiness and sedation). FDA indicated patients should discontinue treatment after eight weeks if they do not report an improvement in sexual desire and associated distress.
Not into medications? If you are bothered by a low sex drive or decreased sexual desire, there are lifestyle changes and sex techniques as well that may put you in the mood more often. Search “libido” on BlackDoctor.org for more information.
SOURCES:
FDA.gov, FDA approves first treatment for sexual desire disorder, Aug. 18, 2015
MayoClinic.org, Low sex drive in women, Aug. 28, 2015