'Female Viagra' approved by US drugs agency
Concerns have been raised over the effectiveness of Flibanserin - marketed as Addyi
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Your support makes all the difference.A drug dubbed the ‘female Viagra’ has finally been approved by the US Food and Drug administration but concerns have been raised over the drug’s possible side effects.
Flibanserin, produced by Sprout Pharmaceuticals, was approved by the FDA on the third application in five years – after twice failing over concerns regarding possible side-effects.
Although the pharmaceutical industry hope the drug will emulate the runaway success of the male impotence drug Viagra, others have noted concerns over the effectiveness of the drug – marketed as Addyi – and its possible side effects may limit it accessibility.
Addyi’s label will have a boxed warning – the most serious – alerting women and doctors to the risks of dangerously low blood pressure and fainting, especially when combined with alcohol.
Problems can also occur should the drug be taken alongside antifungals, such as those commonly used to treat yeast infections. Other side effects can include drowsiness, nausea and dizziness.
The drug, due to be launched in October, was twice rejected by the FDA in 2010 and 2013 after tests failed to demonstrate its effectiveness, with test results experts conceded were “modest”.
Leonore Tiefer, a psychologist and sex therapist who organised a petition last month calling on the FDA to reject the drug, told Associated Press: "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”.
In order to dispense the drug, doctors must complete an online certification process that necessitates counselling patients through the possible risks, while pharmacists must be certified and remind customers not to drink.
But Sprout Pharmaceuticals CEO Cindy Whitehead said they would promote the new drug carefully. "We would never want a patient who's not going to see a benefit to take it and tell everyone it doesn't work," she told AP.
Additional reporting by Associated Press
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