FDA OK’s First OTC Remedy For Overactive Bladder

WebMD Medical News By Kathleen Doheny Reviewed by Laura J. Martin, MD Jan. 25, 2013 — The FDA has approved Oxytrol for Women, the first over-the-counter treatment for overactive bladder in women 18 and older. The condition affects more than 20 million American women, according to Merck, the drug’s manufacturer. It will still only be available in prescription form for men. Oxytrol helps relax the overactive bladder muscle that leads to symptoms such as the sudden need to urinate and leaking of urine. Oxytrol for Women is in the form of a patch, applied to the skin every four days, Merck says. It is expected to hit store shelves by the fall. No cost estimates are yet available, according to Merck. Oxytrol in pill form by prescription will still be available. Oxytrol for Women contains oxybutynin, a drug that helps to relax the bladder muscle. It belongs to a class of drug called anticholinergics. It is the first of this class to go over-the-counter for overactive bladder treatment. Each patch delivers 3.9 milligrams of the drug every day. The FDA approved the drug after reviewing its safety and effectiveness in nine studies involving more than 5,000 women. According to the FDA, the study participants could understand the label information and use the drug appropriately. Among side effects reported in the studies were skin irritation at the site of the patch, constipation, and dry mouth. Merck will supply an educational leaflet with the product. Most women who devel...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - Category: Consumer Health News Authors: Tags: WebMD News Source Type: news