Warning: Beware of over-the-counter bladder medication, consumer group advises

Headlines and newscasters emphasize murders and tragedies in grizzly “if-it-bleeds-it-leads” coverage. Important consumer stories, such as this one warning about a bladder medication that will soon be available on drugstore and supermarket shelves, go unnoticed.

When a new over-the-counter version of a drug for overactive bladder becomes available without a prescription in the fall, people should avoid it if they haven’t first talked with their doctor, Public Citizen, a consumer advocacy group, advises.

The manufacturer of oxybutynin or Oxytrol for Women – a drug for overactive bladder symptoms that has been found to have serious and potentially fatal side effects, especially for the elderly – has announced that the drug will be available OTC starting in the fall. The OTC drug comes in a patch applied to the skin.

The U.S. Food and Drug Administration gave drug manufacturer, Merck, approval to advertise and sell the drug to women over 18, overriding the recommendation of an advisory committee that said the drug shouldn’t be available OTC because of its potential harm to the elderly and to those taking it without a doctor’s oversight.

While the drug can be effective, the side effects can be serious, said Sidney M. Wolfe, M.D., founder and senior adviser of Public Citizen’s Health Research Group and editor of Worst Pills, Best Pills News.

Side effects include constipation, nausea, vomiting, difficulty swallowing, decreased sweating leading to heat-related injuries, difficulty urinating, increased heart rate, dry mouth, daytime sleepiness, blurred vision, and impaired thinking and perception. An uncommon but potentially life-threatening adverse reaction is angioedema, which causes swelling of the lips, tongue, and lining of the throat that could lead to difficulty breathing and respiratory arrest.

OAB is a chronic problem occurring in both women and men, the symptoms of which include urinary urgency and frequency, including at night, and urge incontinence. For patients with these symptoms, a medical evaluation that includes urine tests should be performed to rule out other more serious conditions, Wolfe said.

For patients diagnosed with OAB, doctors recommend noninvasive, nondrug therapies and lifestyle modifications before turning to drugs such as oxybutynin. For example, the first trial comparing behavioral treatment to oxybutynin, conducted in older women and published in 1998, found that behavioral treatment reduced the number of incontinence episodes by an average of 81 percent, compared with a 69 percent drop for oxybutynin-treated patients.

“Be very careful with this drug,” he said. “It should not be your first option, and if you want to use it at all, make sure to talk with your doctor beforehand. Stop after two weeks, or if side effects start to appear. Once again, FDA approval does not a safe drug make.”

Copyright 2013, Rita R. Robison, Consumer Specialist