As of Tuesday, “The Little Pink Pill” is FDA approved for boosting female libido and has become the first treatment on the market that addresses sexual dysfunction issues in women. It has been a long run for drug maker, Sprout Pharmaceuticals, who have gone through the procedures twice before and received a rejection.
However, the Food and Drug Administration (FDA) advisory panel has voted in favor for flibanserin, otherwise known as “female Viagra”, to be taken into consideration by the agency once more. And now, it has officially been approved to be distributed to doctors and pharmacies across the United States.
Previously, there have been 25 drugs to treat male sexual dysfunction, plus the well-renown “little blue pill”, but none to address the same issue in women.
The drug received the new name Addyi, and is designed to work on premenopausal women who suffer from hypoactive sexual desire disorder (HSDD), who lack sexual desire, thoughts or the absence of fantasies of that particular nature. After two rejections, it’s now available on the market, though with some severe warnings.
Every bottle of Addyi will contain the boxed warning that it should not be taken with alcohol or other prescribed medications such as antifungals, commonly used to treat yeast infections. They might cause low blood pressure (hypotension) or loss of consciousness, such as fainting.
The FDA has taken strict precautions to make sure the side-effects will be properly explained to future patients, and have sent out online certification forms for doctors to carefully peruse through before being allowed to prescribe Addyi.
Furthermore, they emphasize the need for medical professionals to warn of its effects when taken with alcohol, and recommend that they should not prescribe it at all if they are aware the patient will not be able to abstain. Meanwhile, pharmacies as well have been instructed to remind customers not to mix the drug with alcohol upon handing out the medication.
While called “the female Viagra”, Addyi works a bit differently by stimulating the brain chemicals and releasing hormones that enhance sexual desire. It must be taken daily, before bedtime and it’s strictly recommended as “safe and effective” for women who have not yet reached menopause.
Drug manufacturer, Sprout Pharmaceuticals, has also been required by the FDA to conduct three more studies to gain a better grasp of its effects when accompanied with alcohol, in order to eliminate the possibility of serious risks upon the patient’s health.
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