FDA Approval: Bladder Control Drug to be Sold Over-the-Counter

FDA Approval: Bladder Control Drug to be Sold Over-the-Counter

Today, the FDA approved Oxytrol for Women, a patch containing oxybutynin that treats overactive bladder, for over-the-counter sale to women ages 18 and older. Men still need a prescription for the drug.

Oxybutynin is an anticholinergic agent that treats overactive bladder by relaxing the bladder muscles and decreasing muscle spasms. This is the first time an anticholinergic agent has been approved for OTC sale.

The approval comes in spite of an FDA advisory committee’s November vote recommending against OTC availability. Concerns cited include patients’ ability to self-select, and the possibility of men using the product off-label.

Merck, the company that will manufacture Oxytrol for Women, did not seek approval for OTC use in men, because studies showed that men were not reliably able to determine whether the drug was the appropriate treatment for their urinary problems. In men, incorrect diagnosis of urinary issues could delay the detection of prostate cancer.


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