First OTC treatment for overactive bladder in women approved
Overactive bladder is a condition that is characterized by leaking urine, feelings of sudden and urgent need to urinate, and frequent urination. It affects about 33 million Americans, most of whom are older women. In January 2013, the U.S. Food and Drug Administration approved the first over-the-counter (OTC) medication available to treat overactive bladder. Oxytrol for Women was approved for OTC use in women aged 18 years and older based on studies showing that women are able to appropriately recognize symptoms of overactive bladder, decide if the patch is right for them, and correctly and safely use the product. Oxytrol for Women contains oxybutynin, which is an anticholinergic drug that helps relax the bladder. The product is a topical patch that is applied to the skin every 4 days. Each patch delivers 3.9 mg of oxybutynin daily. Its reported side effects are mild and include skin irritation where the patch is applied, dry mouth, and constipation.
For men with overactive bladder, the Oxytrol topical patch will continue to be available by prescription only. The dose of the prescription Oxytrol topical patch is the same as Oxytrol for Women (oxybutynin 3.9 mg daily).
For more information on Oxytrol for Women, please visit: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm336815.htm