FDA approves over-the-counter Oxytrol for Women to treat overactive bladder
The U.S. Food and Drug Administration today approved Oxytrol for Women, the first over-the-counter treatment for overactive bladder in women ages 18 years and older.
Oxytrol will remain available for men with overactive bladder by prescription only.
Overactive bladder is a condition in which the bladder squeezes too often or squeezes without warning. Symptoms include leaking urine (urinary incontinence), feeling the sudden and urgent need to urinate, and frequent urination. Overactive bladder affects an estimated 33 million Americans, the majority of whom are older women.
Oxytrol for Women contains oxybutynin, a medicine that helps relax the bladder muscle. Oxybutynin belongs to a class of drugs known as anticholinergics. It is the first drug in this class to be made available over-the-counter for treatment of overactive bladder.
Oxytrol for Women is a patch that is applied to the skin every four days. The patch delivers 3.9 milligrams of oxybutynin per day.
“Studies demonstrate that over-the-counter Oxytrol for Women is a safe and effective treatment for overactive bladder,” said Shaw Chen, M.D., Ph.D., deputy director of the Office of Drug Evaluation IV in the FDA’s Center for Drug Evaluation and Research. “Women should make sure to follow the Drug Facts label and consult their doctor if their condition does not improve.”
Oxytrol for Women’s safety and effectiveness for over-the-counter use were established in more than 5,000 subjects participating in nine studies. Overall, results from these studies showed that consumers can understand the information on the label, properly select whether the product is right for them, and use the drug appropriately.
Side effects reported during clinical studies were mild and included skin irritation where the patch was applied, dry mouth and constipation. A leaflet with tips to help manage overactive bladder will be provided with the product.
Oxytrol for Women is marketed by Merck, based in Whitehouse Station, N.J.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.