Hypoactive sexual desire disorder (HSDD) is defined as low sexual desire that causes distress and is NOT due to a medical or mental health problem, problems within the relationship, or medications or other drug use. Addyi is approved to treat low sexual desire in women who have not gone through menopause, who have not had problems with low sexual desire in the past, and who have low sexual desire no matter the type of sexual activity, the situation, or the sexual partner.
Short track record means that new‚ unexpected side effects may emerge - most likely in the first 3 years after approval. Addyi was approved by FDA in 2015. Clinical trials done before approval generally study a limited number of people for a relatively short time. Important side effects may emerge after Addyi is on the market when larger numbers of people - with other conditions and on other medications - have used the drug. Since Addyi is the first drug approved for HSDD‚ experience is particularly limited.
The drug company was required to conduct additional studies about possible side effects‚ including dangerously low blood pressure, fainting, accidents or injuries, deaths, appendicitis, and harms to women or babies during pregnancy. Because the alcohol studies done prior to approval were done in men rather than premenopausal women (21 of 24 people in the trial were men), FDA is requiring 3 alcohol interaction trials testing how dangerous Addyi is with the “real world” use of alcohol. None of these studies have done been done yet.
Can increase chance of severe low blood pressure and fainting
Including amprenavir (Agenerase), atazanavir (Reyataz, in Evotaz), boceprevir (Victrelis), ciprofloxacin (Cipro), clarithromycin (Biaxin, in Prevpac), conivaptan (Vaprisol), diltiazem (Cartia XT, Diltzac, Tiazac, others), erythromycin (E.E.S., Ery-Tab, Erythrocin), fluconazole (Diflucan), fosamprenavir (Lexiva), indinavir (Crixivan), itraconazole (Onmel, Sporanox), ketoconazole (Nizoral), nefazodone, nelfinavir (Viracept), posaconazole (Noxafil), ritonavir (Norvir, in Kaletra, in Viekira Pak), saquinavir (Invirase), telaprevir (Incivek), telithromycin (Ketek), verapamil (Calan, Covera, Verelan, in Tarka), and grapefruit juice
Increases Addyi blood levels which can lead to severe low blood pressure and fainting
Makes Addyi less effective
Can increase chance of low blood pressure, fainting, and sleepiness
Unknown if Addyi will harm your unborn baby
Do not breastfeed while taking Addyi - either stop breastfeeding or stop Addyi