Off-label uses of Addyi may drive sales, despite possible side effects.
The first-ever drug intended to treat women who suffer from low sexual desire came to the market, despite concerns by many doctors about the drug’s effectiveness and potential side-effects. Now some physicians are raising new concerns, given the common practice of prescribing drugs for uses beyond those for which they were strictly approved.
The drug, called fibanserin but sold under the brand name Addyi, came to the market for the first time on Saturday, according to Scientific American. While it is sometimes referred to as the “female Viagra,” that name obscures the critical differences between the mechanisms and purposes of the two drugs.
Unlike Viagra, which can be taken only when desired, works within hours, and has a physiological effect, Addyi must be taken consistently for weeks before it takes effect, and scientists are not sure why it may help some women, according to an article in Quartz. Side effects of Addyi can include extremely low blood pressure and loss of consciousness, problems that become even more likely in women who drink any alcohol. As a result, women taking the drug are counseled to avoid even social drinking.
In addition, Addyi showed little effectiveness in clinical trials, with few women showing significant improvement in sexual desire. Given these issues, FDA approval of Addyi was considered controversial.
Now some doctors are concerned that the drug may be prescribed for women who are taking antidepressant drugs, since those treatments can often lead to low sexual desire. Using the drug this way would be considered an “off-label” treatment, a common but controversial practice that allows doctors to try approved drugs in patient populations who have not been fully researched in clinical studies.
One small study involving women on antidepressants who were given Addyi showed that adding the drug did not worsen their symptoms, but did in some women slightly increase the risk of insomnia and other side effects.
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