Viagra and other medications for male sexual dysfunction have been found to not help women. Various drug approaches for raising a woman’s libido have not been successful. Boehringer Ingelheim, a private German pharmaceutical, has requested FDA approval for their experimental drug flibanserin (brand name Girosa), also known as the “pink Viagra”. Flibanserin works on increasing serotonin neurotransmitter in the brain and was originally developed as an antidepressant. The FDA’s preliminary review questions if the drug is safe.
The FDA has conducted a preliminary review of two flibanserin clinical studies. They found that flibanserin failed to increase women’s libido although it increased sexually satisfying experiences. Furthermore, the study participants commonly reported side effects including depression, fainting, accidental injury, fatigue, drowsiness and sedation. About 15 percent of participants stopped taking flibanserin before the study ended due to the side effects.
“Therefore, neither study met the agreed-upon criteria for success in establishing efficacy,” the FDA reviewers state, in a news report. “It is not clear if labeling alone will be sufficient to alert women to the numerous drug interactions that exist with flibanserin.”
After reviewing the panel recommendations, the FDA will make a final decision about flibanserin’s approval. Boehringer claims that flibanserin’s safety and efficacy has been demonstrated in studies. They found moderate potential side effects.
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