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 announcing the approval Tuesday.
Online certification process
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.
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. They point out that the FDA rejected the drug twice, in 2010 and 2013, due to these risks.
It takes weeks or months to see any benefit
“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 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 turnaround for the FDA, which previously rejected the drug twice due to lack-luster effectiveness and side effects. The decision represents a compromise of sorts between two camps that have publicly feuded over the drug for years.
Safety advocates are critical of the drug
On one side, Sprout and its supporters have argued that women desperately need FDA-approved medicines to treat sexual problems. On the other side, safety advocates and pharmaceutical critics warn that Addyi is a problem-prone drug for a questionable medical condition.
Beginning with the drug’s launch in mid-October, doctors who see patients complaining about a loss of sexual appetite will have a new option.
Beginning with the drug’s launch in mid-October, doctors who see patients complaining about a loss of sexual appetite will have a new option.
“Women are grasping, and I feel like we need to offer them something that acknowledges that, and that we can feel safe and comfortable with,” said Dr. Cheryl Iglesia, a surgeon and official with the American Congress of Obstetricians and Gynecologists. Iglesia said she has occasionally resorted to prescribing testosterone creams to boost women’s libido, a use not approved by the FDA.
One additional “sexually satisfying event” per month
Company trials showed women taking the drug generally reported one extra “sexually satisfying event” per month, and scored higher on questionnaires measuring desire.
Critics said the FDA was pressured into approving the drug by a feminist-themed lobbying campaign funded by Sprout and other drugmakers.
The lobbying group, dubbed Even the Score, began publicizing the lack of drugs for female sexual dysfunction as a women’s rights issue last year.
“Women deserve equal treatment when it comes to sex,” the group states in an online petition to the FDA, which attracted more than 60,000 supporters. Women’s groups, including the National Organization for Women, signed on to the effort, though it was funded by Sprout and other companies working on female sex drugs.
Drug approved for women with low libido
The FDA specifically approved the drug for premenopausal women with hypoactive sexual desire disorder, a lack of sexual appetite that causes distress.
Surveys estimate that 8 to 14 percent of women ages 20 to 49 have the condition, 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.
The diagnosis is not universally accepted, and some psychologists argue that low sex drive should not be considered a medical problem.
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Associated Press video journalist Ted Shaffrey in New York contributed to this report.
Author: ANA Newswire
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