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FDA Approves "Female Viagra" Pill

Discussion in 'Gynaecology and Obstetrics' started by Egyptian Doctor, Sep 16, 2015.

  1. Egyptian Doctor

    Egyptian Doctor Moderator Verified Doctor

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    Earlier this year, we reported on how the government health officials who advise the U.S. Food and Drug Administration (FDA) had backed what is being called “female Viagra,” voting 18-6 in favor of the drug. It seems that the FDA has taken their advice on board, and finally given it the green-light. Designed to increase a woman’s libido by altering chemicals in the brain, the newly approved drug is expected to be made available through health professionals and pharmacies by October this year.

    Because it works in a different way to traditional Viagra, which simply relaxes muscles and increases blood flow to certain regions of the body, the female version has to be taken daily in order to alter the balance of dopamine and serotonin in the brain. These hormones are known to play a role in sexual desire and motivation, and it’s thought that by changing these, it could help women suffering from Hypoactive Sexual Desire Disorder.

    It is this daily dose that has been the crux of the FDA’s issues with the drug, called flibanserin, and is the reason why it has taken three attempts before the FDA would approve it. The organization has also previously cited side effects such as dizziness, nausea, and low blood pressure as real concerns. In addition to this, despite the manufacturer of the drug, Sprout Pharmaceuticals, claiming that between 46 and 60% of women experienced “beneficial” results, other scientists have countered that the real figure is much lower, possibly in the region of 8–13%.

    To be marketed under the name Addyi, the FDA has said that the drug should be taken daily for no more than eight weeks if there has been no improvement in the patient’s sexual libido. Advocates of the pill have claimed that the only reason it has taken this long to produce a drug for sexual desire marketed at women has been an inherently sexist society, and point to the fact that there are already six separate drugs aimed at treating erectile dysfunction but only one sexual desire drug for women.

    But as the committee concluded in their June assessment of the drug, as currently women have nothing on the market to help them with low sexual desire, the pill should be made available even if the benefits are moderate, provided that it carries suitable warning and that patients are fully aware of all side effects.

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