Press Trust of India
Washington, August 19: The first drug to treat low sexual desire in premenopausal women, dubbed “female Viagra”, has been approved in the US, but with a warning about potentially dangerous side effects such as severe low blood pressure and fainting. The US Food and Drug Administration Tuesday approved Addyi (flibanserin) to treat acquired, generalised hypoactive sexual desire disorder (HSDD) in premenopausal women. Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women. “Wednesday’s approval provides women distressed by their low sexual desire with an approved treatment option,” said Janet Woodcock, director of the FDA’s Centre for Drug Evaluation and Research (CDER).
HSDD is characterised 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, FDA said. HSDD is acquired when it develops in a patient who previously had no problems with sexual desire. HSDD is generalised when it occurs regardless of the type of sexual activity, the situation or the sexual partner. “Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies,” said Woodcock. “Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment,” she said. Addyi can cause severely low blood pressure (hypotension) and loss of consciousness (syncope).
