Despite dangerous risks including causing unconsciousness to its users, a drug said to treat sexual dysfunction in pre-menopausal women has been approved by the United States' Food and Drug Administration (FDA).
The newly approved drug, called Flibanserin from Sprout Pharmaceuticals, will be sold under the brand name Addyi. It is also commonly known as "female viagra" and "the little pink pill."
Addyi is classified as an anti-depressant and works on the central nervous system. It particularly changes how brain cells respond to various message carrying chemicals called neurotransmitters, thereby improving a woman's sexual drive over time.
This is the first drug that revives and enhances a flagging or absent sexual drive for either sexes to be approved by the FDA. The more popular pill for men, Viagra, treats erectile dysfunction and does not induce sexual desire.
Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said Addyi's approval will help women "distressed by their low sexual desire."
"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," Woodcock said in a statement on Addyi's approval.
Dr. Lauren Streicher, associate professor of clinical obstetrics and gynecology at Northwestern University, meanwhile considered Addyi's approval as a "game changer."
"I think this is going to change the conversation that's taking place in medical offices across the country," Streicher said.
The drug was approved despite risks, particularly the risk of causing severe low blood pressure to its users.
Individuals who take Addyi while drinking alcohol may also experience temporary loss of consciousness. This has prompted the FDA to require the drug's manufacturer to include a strong "boxed warning" to notify patients who drink alcohol and have liver problems not to take Addyi.
The FDA also asked for a risk evaluation and mitigation strategy, or REMS, for the drug to ensure safety of its users.
