First female Viagra approved by the FDA — but there are side effects

19 Aug 2015

First female Viagra approved, but watch out for side-effects

The Federal Drugs Authority (FDA) has approved Addyi (Flibanserin), nicknamed the world’s first female Viagra, aimed at treating low sexual libido in women. However, it comes with a warning of side effects, including low blood pressure and fainting.

Addyi, which is manufactured by Sprout Pharmaceuticals, is aimed at treating hypoactive sexual desire disorder (HSDD), or low libido in premenopausal women, which is said to affect nearly one in 10 women.

“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” said Dr Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER).

“The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”

No alcohol allowed with new female Viagra

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.

HSDD is diagnosed when symptoms develop in a patient who previously had no problems with sexual desire.

“Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified healthcare professionals and certified pharmacies,” continued Dr Woodcock.

“Patients and prescribers should fully understand the risks associated with the use ofAddyi before considering treatment.”

The FDA said that Addyi comes with side effects like low blood pressure and loss of consciousness, which are increased when patients drink alcohol or take it with other medicines.

The drug will be only issued by certified prescribers who must also counsel patients about the increased risk of severe hypotension and syncope and about the importance of not drinking alcohol during treatment.

Female viagra image via Shutterstock

John Kennedy is a journalist who served as editor of Silicon Republic for 17 years

editorial@siliconrepublic.com