FDA OKs female sex pill with restrictions
WASHINGTON — The Food and Drug Administration 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 — 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, director of the FDA’s drug center, in a statement.
Under an FDA-imposed safety plan, doctors will only be able to prescribe Addyi after completing an online certification process that requires counseling 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’s not worth the side effects, which also include nausea, drowsiness and dizziness.
“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.
