Safe Use OTC Switching

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  • 01/25/2013

How many times have you read, “The FDA is not required to follow the advice of its advisory panels but usually does."

Except when it doesn’t.

Recently an agency advisory panel voted against recommending making oxybutynin transdermal patch (Oxytrol) available over-the-counter (OTC) for overactive bladder (OAB) in women.

In their 5-6 vote, panelists on the FDA's Nonprescription Drugs Advisory Committee noted their concerns that women would use Oxytrol thinking they had OAB when they really had some other ailment that needed a physician's treatment. They also were concerned about men using the product off-label.

Some also were worried about the high amount of potential misuse -- whether it was by patients who did not have indications for proper use, or those it was meant for that didn't use the product correctly.

Well, today the FDA ruled that a patch containing oxybutynin (Oxytrol) for controlling overactive bladder may be sold over-the-counter for women 18 and older.

Men will continue to need a prescription for the drug, the agency said. The OTC product will be marketed by Merck as Oxytrol for Women.

In considering an Rx-to-OTC switch, the FDA looks to see whether patients can use the product safely without the oversight of a physician or pharmacist. This includes ensuring that the right patients use the drug in the appropriate way ("safe use"). The agency is not evaluating the risk-benefit of the product, since that was done earlier when it was approved as a prescription drug.

But, considering all of the issues surrounding this particular switch (conditions can cause symptoms similar to those of OAB, including urinary tract infection, bladder malignancy, pregnancy, prostate disease, and uncontrolled diabetes mellitus), AdComm panelists (who voted no) said those conditions need a physician's care, and an OTC oxybutynin could delay treatment. Shouldn’t the FDA have asked Merck for a “safe use” plan – in addition to the age restriction? Sort of REMS for OTC products?

Note to FDA – there’s an app for that.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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