The first drug to treat low sexual desire in women, touted as the “female Viagra,” won approval from the U.S. Food and Drug Administration. The health regulators approved the drug Addyi after twice rejecting the treatment because they did not think the benefits outweighed the drug’s risks, an article in Reuters reports.
Addyi is designed for women with a condition known as hypoactive sexual desire disorder. According to PubMed.gov, this condition occurs when a women’s lack of sexual desire causes distress. It is suspected to occur in up to a third of women in the United States.
The new drug was originally developed by Germany’s Boehringer Ingelheim and was rejected in 2010 after an advisory panel said the benefits did not outweigh the risk. Sprout Pharmaceuticals purchased the drug and resubmitted an application in 2013 after conducting additional studies. Again, the FDA rejected the drug. According to Reuters, the second rejection stirred up women’s activist groups. The groups accused the FDA of gender bias, based on its approval of Viagra for men. The FDA rejected the claim.
While it is compared to Pfizer’s blockbuster drug Viagra, Addyi does not affect blood flow to the genitals. Instead, the drug is meant to activate sexual impulses in the brain. Addyi, first developed as an antidepressant, is “similar to an SSRI in that it works on neurotransmitter receptors in the brain.” The drug “is thought to correct an imbalance in neurotransmitters” according to a Sprout consultant. The drug promotes dopamine release unlike SSRIs that promote the release of Serotonin.
The Reuters article goes on to state that the FDA’s decision to finally approve Addyi came after an advisory board said the drug should be approved, but only with strict measures in place to ensure patients are fully aware of the risks. Addyi will come with a “boxed warning” about potentially dangerous low blood pressure and fainting side effects, especially when taken with alcohol. Public Citizen, a consumer watchdog group that has testified against the drug’s approval, predicts the drug will be pulled from the market within the next few years citing “serious dangers to women, with little benefit to them.” In a clinical study, women who took Addyi had an increase of about one sexually satisfying event per month compared with those taking a placebo.
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