HealthDay News — The FDA has approved oxybutynin (Oxytrol, Merck) as the first over-the-counter treatment for women 18 and older with overactive bladder.
Oxybutynin belongs to a class of drugs called anticholinergics that are designed to relax the bladder muscle. No agent in this class has been available over-the-counter before, the FDA said in a press release.
Oxybutnin will be sold as a patch to be applied to the skin every four days. Overactive bladder is characterized by symptoms including leakage, frequent urination, and feeling the sudden and urgent need to urinate. The condition affects some 33 million Americans, mostly older women.
Approval of the OTC formulation was based on results from nine studies involving more than 5,000 patients. “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,” the FDA said.
Side effects reported during clinical testing included skin irritation at the patch site, dry mouth and constipation.
The drug will remain available for adult men by prescription only, due to concerns that incorrect self-diagnosis could delay treatment for prostate cancer. Study findings showed men were relatively poor at correctly determining whether oxybutynin was the appropriate treatment for their urination problems.