Mark Linnhoefer – On Tuesday, the FDA approved a little pink pill called “Addyi”, or rather its active ingredient, which is known under the name of “flibanserin”. This female Viagra will be used to treat sexual dysfunction in women and it is the first such medication that was ever approved by the FDA.
The director of the FDA’s Center for Drug Evaluation and Research – Dr. Janet Woodcock – said that as “[the] FDA strives to protect and advance the health of women”, they are “committed to supporting the development of safe and effective treatments for female sexual dysfunction.”
While Mrs. Woodcock speaks of “safe […] treatments”, Addyi’s approval is accompanied by a large variety of warnings and safety precautions. The box has to contain a clear warning for patients who consume alcohol or take certain medications. The FDA furthermore only approved the drug with a risk evaluation and mitigation strategy – REMS – that requires pharmacists and other health care providers to undergo a training program upon completion of which they will be certified to sell Addyi whilst warning patients of consuming alcohol when taking the drug and urging them not do so.
The importance of not drinking alcohol arises from the fact that the drug lowers the blood pressure and can lead to nausea, dizziness, or even loss of consciousness, especially when combined with alcohol.
A sexual stimulant that does not work with alcohol may seem like a bad idea, but Addyi does not work like Viagra would for men. The flibanserine is only used in conjunction with other treatment, and, unlike Viagra, it doesn’t affect the body and only focuses on the brain and central nervous system, which is why it was classified in the same category as an anti-depressant.
The side-effects aside, this drug does indeed present “an approved form of treatment” for “women distressed by their low sexual desire”, as Dr. Woodcock put it.
*yes, that’s her actual last name: Woodcock.
You must be logged in to post a comment.