by Long Island Attorney Paul A. Lauto, Esq.
On March 10, 2015 we first reported that after two failed applications, Sprout Pharmaceuticals had applied for a third time seeking FDA approval of the female libido pill Flibanserin (See http://www.liattorney.com/scales-of-justice/fda-considering-approval-of-female-libido-pill). It appears that three times is the charm, as the FDA has now approved Flibanserin as the first drug to combat generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
The most common side effects of the drug include dizziness, somnolence (sleepiness), nausea, fatigue, insomnia and dry mouth. In addition, the drug can cause severely low blood pressure (hypotension) and loss of consciousness (syncope). These additional risks are increased and more severe when patients drink alcohol or take certain other medicines. Accordingly, the use of alcohol is contraindicated and health care professionals must assess the likelihood of the patient’s reliability in abstaining from alcohol before prescribing the drug.
In order to further safeguard women taking Flibanserin, doctors and pharmacists alike are required to become certified in risk evaluation and mitigations strategy (REMS). The FDA has also required a box warning highlighting the severe risks associated with the medication.
Test trials of the drug appear to have had lackluster results. The double blind study found that Flibanserin, as compared to the placebo group, increased the amount of satisfying sexual events by .5 to 1.0 event per month.
See the full article at
http://www.liattorney.com/scales-of-justice/three-times-is-the-charm-for-female-libido-pill
