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FDA Approves First Over-the-Counter Drug for Overactive Bladder (OAB)

January 31, 2013 1 min read

Oxytrol for Women is now available as the first over-the-counter treatment for overactive bladder (OAB) in women ages 18 years and older, the U.S. Food and Drug Administration (FDA) said on Jan. 25. This announcement comes a week after the FDA also approved the use of Botox for individuals suffering from OAB and can’t use or don’t find other treatments useful.

Affecting an estimated 33 million Americans, a majority of whom are women, OAB is a condition that causes frequent urination and sudden urges to urinate. Oftentimes, these urges come on too strongly and quickly, resulting in wetting accidents.

Oxytrol for Women contains oxybutynin, a medicine that helps relax the bladder muscle. Oxybutynin is the first drug to be made available over-the-counter for OAB treatment. Oxytrol for Women comes in a patch form that is applied to the skin and lasts four days. Each 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,” 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, said in a statement. “Women should make sure to the follow the Drug Facts label and consult their doctor if their condition does not approve.”

Common side effects for Oxytrol for Women include: skin irritation where the patch was applied, dry mouth, and constipation. Additional treatments for OAB include kegel exercises, bladder retraining, and dietary changes.

Men with OAB will still need a prescription to obtain Oxytrol.


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