The U.S. Food and Drug Administration has approved libido pill Addyi, more commonly referred to as “Female Viagra,” which will treat sexual dysfunction and pre-menopause in women.
“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “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.”
Though the FDA has approved Addyi, there are still concerns about its many side effects, including increased risk of severe low blood pressure that could lead to a temporary loss of consciousness. The likelihood of the frightening side effect is increased when those using the drug consume alcohol.
Additionally, Addyi’s benefits are modest, showing only half of an event to one additional event of “satisfying sexual” events per month compared to placebo. The FDA overlooked the modest benefits due to the reality that there is no alternative to Addyi to help women with hypoactive sexual desire disorder.
“This is a product that is neither very effective nor particularly safe,” Dr. Susan Wood, a former FDA official now at George Washington University, told NBC News.
“It won’t benefit many women and at the same time the approval comes with a lot of restrictions, setting a precedent that a drug for women’s sexual health has to be treated in a very special way,” Wood said.
Addyi, which will have a comparable monthly cost to Viagra, will become available in October.
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