First female Viagra approved by the FDA – but there are side effects
The Food and Drug Administration has sexual-health/fda-approves-says-no-female-viagra-n411711″ target=”_blank”>approved the first prescription drug aimed at boosting women’s libido, but don’t go calling the new pink pill the “female Viagra”. The drug will be marketed under the brand name Addyi will be targeted at pre-menopausal women to tackle their lack of sexual desire or a condition called hypoactive sexual desire disorder, or HSDD. Instead of sending blood to the sex organs, which is what Viagra does for men, the pill sends chemicals to the brain to increase libido.
The statement added that prescribers and patients should understand fully the risks that are associated with using Addyi prior to considering treatment. “You take it at a set time every day as opposed to something that you would use on demand, for example, for erectile problems in a man”. In June 2015, an advisory panel voted to recommend the approval of Flibanserin with strict risk evaluation and mitigation strategy, or REMS, in place to ensure patients’ safety. However, the drug to enhance sexual desire in women doesn’t work that well and has side-effects.
The 100 mg bedtime dose of flibanserin was administered to about 3,000 generally healthy premenopausal women with acquired, generalized HSDD in clinical trials.
According to a study, women who took the drug got a “sexually satisfying events” more a month, compared to taking a placebo. Addyi is the first and only FDA-approved treatment for this condition, the most common form of female sexual dysfunction, affecting up to 1 in 10 women in the United States.
A public relations campaign called Even the Score lobbied Congress and the FDA for approval.
Patients have been told to discontinue treatment after eight weeks if they do not report an improvement in sexual desire. The chances of these side effects occurring increase significantly if the drug is taken with alcohol or a number of other commonly used medications.
The approval comes with a stern warning, though, as adverse reactions to the drug include low blood pressure and loss of consciousness.