WASHINGTON — The Food and Drug Administration on Tuesday approved the first prescription drug designed to boost sexual desire in women, a milestone long sought by a pharmaceutical industry eager to replicate the blockbuster success of impotence drugs for men.
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 late 1990s.
The drug's label will bear a boxed warning alerting doctors and patients that combining the pill with alcohol can cause dangerously low blood pressure and fainting. That same risk can occur when taking the drug with other commonly prescribed medications, including antifungals used to treat yeast infections.
"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 organized a petition calling on the FDA to reject the drug.
Under a safety plan imposed by the FDA, doctors will only be able to prescribe Addyi after completing an online certification test demonstrating that they understand its side effects. Pharmacies also will have to be certified.
"Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment," said Dr. Janet Woodcock, director of the FDA's drug center, in a statement.
Sprout Pharmaceutical's drug is intended to treat women who report emotional stress due to a lack of libido. Its approval marks a turnaround for the FDA, which previously rejected the drug twice due to lackluster effectiveness and side effects. The decision represents a compromise of sorts between two camps that have publicly feuded for years.
Company trials showed women taking the drug generally reported one extra "sexually satisfying event" per month and scored higher on questionnaires measuring desire.
Opponents of the drug say it's not worth the side effects, which include nausea, drowsiness, dizziness and fainting that can lead to serious injuries.