
Following up on yesterday's post about Female Sexual Dysfunction (FSD), you can take action to prevent a new FSD drug from coming to the market. This drug has unknown side-effects with minimal benefit. Here's what you need to know.What is the new drug?Flibanserin is a serotonergic (brain action) drug manufactured, researched and produced by a Boehringer-Ingelheim (B-I, a German corporation)Is it approved by the FDA?Not yet but there's a hearing on June 18th. You can write a letter to oppose it - more information belowWhat does the drug do?The clinical trial results have never been published so we can't evaluate them but B-I suggests that the drug may help some women have 0.8 more "satisfactory sexual episodes" per month over a placebo.How does the drug work?The precise mechanism of action is unknown, but it is presumed to affect many location in the brain. Both short and long-term changes in the brain are unknown.Are there any dangers or side effects?This is a big question the FDA must address. Drugs always have side-effects and serotonin drugs are known to cause birth defects and pregnant or breast-feeding women are advised not to use them. Flibanserin has to be taken daily for weeks before any results are shown - that is a lot of drug taking for a minimal benefit. The main concern here is that the marketing of this drug will establish a new sexual standard of consistent high sexual desire and performance and that all women will be affected by ever-higher expectations.Want more information? Go
here.Want to write a letter?You can send letters to the FDA (address below - e-mail or print) before June 3rd. Be brief and to the point and remember, you don't have to be an "expert" to write in - just a concerned citizen. This drug would affect brain chemistry!Address letters to the "Reproductive Health Advisory Committee considering Flibanserin on June 18, 2010"Address: Ms. Kalyani BhattCenter for Drug Evaluation and Research (HFD-21)Food and Drug Administration5600 Fishers Lane (express delivery, 5630 Fishers Lane, Rm 1093)Rockville, MD 20857Phone: 301-827-7001Fax: 301-827-6776E-mail: kalyani.bhatt@fda.hhs.govPlease write in to help stop this drug from being approved!