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FDA Okays Over-the-Counter ‘Oxytrol for Women’ for Overactive Bladder

First OTC bladder treatment for women aged 18 years and older (Jan. 25)

The FDA has approved Oxytrol for Women (oxybutynin, Merck) — the first over-the-counter (OTC) treatment for overactive bladder in women aged 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 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 the anticholinergic drug oxybutynin, which helps relax the bladder muscle. Oxybutynin is the first drug in this class to be made available OTC for the treatment of overactive bladder. Oxytrol for Women is a patch that is applied to the skin every 4 days. The patch delivers 3.9 mg of oxybutynin per day.

The safety and effectiveness of Oxytrol for OTC 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, can properly select whether the product is right for them, and can 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.

Source: FDA; January 25, 2013.

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