Hastily approved by the FDA, and after overriding the advice of the drug advisory committee, BRISDELLE is billed as “the first and only FDA approved non-hormonal therapy for moderate to severe hot flashes associated with menopause.
Marketed as non-hormonal, the drug’s advertising alludes to the practice of hormone replacement therapy, which was in wide-use until non-hormonal drugs were proven to increase the occurrence of heart attacks, strokes, blood clots, and even breast cancer. As a result of these dangers, few women continue to use hormone replacements.
Noven, in an attempt to fill the void in hormone replacement usage, labels their drug as a hot flash reducer, an antidepressant, and a treatment for such conditions as OCD, panic, social anxiety, and posttraumatic stress.
In March of 2013, an FDA advisory committee met to review the effectiveness and safety of BRISDELLE, and determined that not only did the drug fail to show any significant benefits to the patients over the placebo product, but it actually increased the dangers of adverse side effects such as seizures, convulsions, manic episodes, and sexual problems.
Although approved by the FDA, BRISDELLE is not recommended as a hot flash reducer and should be avoided at all costs. It is characterized as a “DO NOT USE” drug, and if you are taking the medication currently, you should consult with your doctor to understand how to correctly discontinue use, and minimize your risk.
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