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FDA Approves “Female Viagra”

“Female Viagra” Pill Has Been Approved by the FDA, but Carries a Strong Warning Because of Side Effects

female viagraIt’s no secret that Viagra is one of the most sought-after prescription medications in history. Ever since “the little blue pill” was approved by the FDA, the pharmaceutical industry has gone in search of the illusive equivalent for women – “the little pink pill.”

And Addyi, the brand name for generic drug Flibanserin, is little and pink. However, the drug works differently than Viagra. Rather than stimulate blood flow to the genital region, flibanserin instead is designed to boost certain “good” brain chemicals which allow women to feel more satisfaction after sexual encounters. Drug company Sprout acquired the chemical formula from Germany’s Boehringer Ingelheim, despite the FDA’s rejection of the formula in 2010. Sprout made some minor changes and presented the drug again to the FDA in 2013, but it was again rejected. That’s when Sprout began an intense lobbying campaign, accusing negative cultural attitudes towards women’s sexuality for stopping the drug’s progress through the federal safety regulator.

Now that the FDA has approved the drug, however, significant questions are being raised about the drug’s safety and efficacy. Addyi will come with a “boxed warning” that details potential side effects of taking the medication, including liver problems, low blood pressure, fainting spells, dizziness, and unanswered potential problems involving alcohol consumption, birth control, psychiatric medications, and steroids.

Women who take birth control and consume alcohol on a regular basis could experience severe side effects.  In addition, more and more Americans are on psychiatric medications, primarily antidepressants – a drug that causes harmful interactions with those medications will reduce the overall happiness of the women taking it, which is not the point of approving a drug to improve sexual arousal.

In addition, the chemical formula of Addyi is similar to that SSRIs, or selective serotonin reuptake inhibitors. Other drugs in this class are Wellbutrin and Prozac, both of which have been accused of causing birth defects in women who take them while pregnant. There is an unclear link between SSRIs and birth defects, but there are already several personal injury lawsuits involving allegations that the pharmaceutical companies knew about the dangers and marketed the drugs as safe anyway.

Legitimate questions have been raised about the drug’s effectiveness in its numerous trials, as well. Flibanserin can, given no other factors standing in the way of sexual encounters, increase the desire for sex to once per month on average, based on studies. A CNN article on “the little pink pill’s” effectiveness noted a study by psychologists Andrea Bradford and Cindy Meston reported a similar rise in sexual desire from women taking a placebo, especially in women who were in long-term relationships. This problem was one of the initial reasons the FDA cited when it rejected the drug.

 

About Pete Strom

Defending criminal charges including drug crimes, DUI, CDV, mail fraud, wire fraud, bank fraud, computer crimes, money laundering, and juvenile crimes, Pete also handles Federal and State investigations. Representing individuals in Civil Matters including Class Actions, Personal Injury, Qui Tam Actions, Defective Products, Nursing Home Neglect, and Professional Licensing Defense cases. Joseph Preston “Pete” Strom, Jr., the managing partner at Strom Law Firm, L.L.C., has been fighting for justice since 1984.

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