Female Viagra Approved Amid Controversy

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With the popularity of erectile dysfunction medications like Viagra and Cialis, many wondered why women were not getting their own version of the sexual dysfunction medication. Now the United States Food and Drug Administration (FDA) has approved what some have dubbed female viagra, but not without warnings and controversy.

As many expected, since a panel recommended the approval back in June, the FDA officially approved Addyi on Tuesday. The drug has the generic name flibanserin and comes from Sprout Pharmaceuticals. Addyi will be available only through specially trained health professionals who are certified to prescribe the medication, due to its potential side effects.

The drug received approval for premenopausal women who have a lack of sexual desire that is causing them distress, a condition known as hypoactive sexual desire disorder (HSDD). Although many are calling Addyi the female viagra, there are many differences between it and the erectile dysfunction drugs for men. Although men take viagra shortly before a sexual encounter, women will have to take Addyi daily to have the desired effect. It also works differently than viagra, targeting the mental aspects of sex much like an SSRI antidepressant versus increasing blood flow to the sexual organs like viagra.

The drug’s approval has been met with mixed reactions. Some are celebrating the approval as a victory for women’s equality after accusing the FDA of gender bias. Making Addyi available means that regulators consider female sexual dysfunction a legitimate problem, just like male sexual dysfunction. It also means that women who are having these issues can take control of their situation the same way men can since 1998 with Viagra’s approval.

However, many tout the negative side of the drug. The medication was twice rejected by the FDA because it only made a small improvement in sexual function with side effects to go along with it. Regulators warn that the drug has the potential to cause dangerously low blood pressure as well as fainting, especially if women drink alcohol as well. Critics argue that an increase of one satisfying sexual event per month for study participants, on average, is not worth the risk of the side effects. Others argue that this can make a meaningful difference in the lives of those suffering from sexual dysfunction.

Although not everyone is on board with the new female sexual dysfunction drug, there could be more options for women in the future. Palatin Technologies has been developing a rival drug called bremelanotide. Unlike Addyi, this particular drug would be taken only as-needed, not every day. It would work differently than Addyi, activating certain pathways in the brain to increase sexual desire.

There is no word yet on when Addyi will be available to patients. Although there is also no official price tag on the female dysfunction drug yet, the CEO of Sprout Pharmaceuticals, Cindy Whitehead, has stated that the monthly cost of the drug should be comparable to the average monthly cost of Viagra. Those in the United States might expect to pay about $400 a month for Viagra, which could be a $30 to $75 a month copay for those with health insurance. However, it is still unclear whether insurers will cover the cost of the female sexual dysfunction drug. Currently, while some insurers will cover Viagra with documented proof of a medical condition, others do not cover the drugs for men.

While the approval of Addyi has stirred up some controversy, at least it will give women options. With strong warnings about the possible side effects of the sexual dysfunction drug, women can make an informed decision about whether the possible benefits are worth the risk for them.

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