The first drug aimed to fight low sexual desire in women was dinally approved by the U.S. Food and Drug Administration.

The U.S. health regulators has approved a libido-enhancing drug for women dubbed the “female Viagra”.

Flibanserin is produced by Sprout Pharmaceuticals and marketed as Addyi. It has been long criticised for having only marginal benefits.

Unlike Viagra, which influences blood flow to the genitals, Addyi was created to help women regain their sex drive by boosting levels of brain chemicals.

“This is the biggest breakthrough in women’s sexual health since the advent of ‘the Pill'” for contraception, The National Consumers League said in a statement. “It validates (and) legitimizes female sexuality as an important component of health.”

However, Public Citizen, a consumer watchdog group that stands against the drug, predicted that Addyi will be pulled from the market within a few years because of “serious dangers to women, with little benefit” to them. “Unfortunately, we haven’t heard the last of this drug.”

“Flibanserin can cause serious harms, including unpredictable hypotension and sudden unconsciousness, and its adverse effects are exacerbated by alcohol, oral contraceptives, antifungals, triptans and many other drugs,” a team of around 200 researchers said in a letter sent to the FDA earlier this year, demanding that the agency reject the drug.

“Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment,” warned Dr. Janet Woodcock, director of the FDA’s drug center, in a statement announcing the approval Tuesday.

“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,”she added. “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.”

When announcing the approval the FDA specified that doctors will only be able to prescribe the drug only after completing an online certification that requires warning patients about Addyi’s risks. Pharmacists will also need certification and will be required to remind patients not to drink alcohol while taking the drug.

Opponents of Addyi claim that the drug is not worth the side effects, which also include nausea, drowsiness and dizziness. They also remind that the U.S. Food and Drug Administration rejected the drug twice, in 2010 and 2013, due to these risks.

“This is not a drug you take an hour before you have sex. You have to take it for weeks and months in order to see any benefit at all,” explains Leonore Tiefer, a psychologist and sex therapist who organized a petition last month calling on the FDA to reject the drug.

Nevertheless, Addyi producer is quite enthusiastic about the approval.

“It has been a remarkable journey to get to this breakthrough moment. Today we celebrate what this approval means for all women who have long awaited a medical treatment option for this life impacting condition,” said Cindy Whitehead, chief executive officer of Sprout. “We applaud the FDA for putting the patient voice at the center of the conversation and for focusing on scientific evidence.”

Recently held surveys have showed that 8 to 14 percent of women from 20 to 49 have hypoactive sexual desire disorder, a lack of sexual appetite that causes distress., or about 5.5 to 8.6 million U.S. women.

Because so many factors affect sexual appetite, there are a number of alternate causes doctors must rule out before diagnosing the condition, including relationship issues, medical problems, depression and mood disorders.

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