The first prescription drug designed to boost sexual desire in women has been approved by regulators in the US.
The move by the Food and Drug Administration (FDA) was a milestone long sought by a pharmaceutical industry eager to replicate the blockbuster success of impotence drugs for men.
Patients should fully understand the risksDr Janet Woodcock
But stringent safety measures on the daily pill called Addyi mean it will probably never achieve the sales of Viagra, which has generated billions of dollars since the 1990s.
The drug’s label will bear a boxed warning – the most serious type – alerting doctors and patients to the risks of dangerously low blood pressure and fainting, especially when the pill is combined with alcohol.
The same problems can occur when taking the drug with other commonly prescribed medications, including antifungals used to treat yeast infections.
“Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment,” said Dr Janet Woodcock of the FDA’s drug centre.
Under an FDA-imposed safety plan, doctors will only be able to prescribe Addyi after completing an online certification process that requires counselling 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 the drug say it is not worth the side effects, which also include nausea, drowsiness and dizziness. They point out that the FDA 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,” said Leonore Tiefer, a psychologist and sex therapist who organised a petition last month calling on the FDA to reject the drug. Patients should stop taking the drug after eight weeks if they do not see any improvement, notes the FDA release.
Sprout Pharmaceutical’s drug is intended to treat women who report emotional stress due to a lack of libido. Its approval marks a U-turn by the FDA, which previously rejected the drug twice due to lacklustre effectiveness and side effects.
The decision represents a compromise of sorts between two camps that have publicly feuded over the drug for years.
On one side, Sprout and its supporters have argued that women need FDA-approved medicines to treat sexual problems. But safety advocates and pharmaceutical critics warn Addyi is a problem-prone drug for a questionable medical condition.
Beginning with the drug’s launch in October, doctors who see patients complaining about a loss of sexual appetite will have a new option.