Over-the-Counter Oxytrol Side Effects May Be Serious, Group Warns

The prominent consumer watchdog group Public Citizen is warning consumers to stay away from a new over-the-counter medication that will soon be available for treatment of overactive bladder (OAB), suggesting that side effects of Oxytrol for Women may pose a risk of serious and potentially life-threatening health problems.  

Oxytrol (Oxybutynin) for Women will soon be available for the first time without a prescription, and Public Citizen has released a statement indicating that consumers should avoid the medication if they have not spoken with their doctors first, suggesting that it could cause respiratory arrest and other adverse events.

Merck & Co. will begin selling the Oxytrol transdermal patch for women over the age of 18 without a prescription starting in the fall. Oxytrol remains as a prescription drug for men only.

Public Citizen strongly warns consumers against using it due to some severe and potentially fatal side effects, especially among the elderly. Side effects may include constipation, nausea, vomiting, difficulty swallowing, difficulty urinating, increased heart rate and angiodema.

Angiodema is one of the more uncommon and potentially life threatening side effects of using Oxytrol. It can cause swelling of the lips, tongue and lining of the throat leading to trouble breathing, eventually causing respiratory arrest.

Over-the-Counter Approval Came Despite Warnings

The drug was recently approved by the FDA and will soon be available for sale. The FDA approved the drug despite the recommendation of the Nonprescription Drugs Advisory Committee in November 2012. Six of the 11 people on the committee voted against making the drug available over-the-counter (OTC).

Committee members voted whether they believed the available data on the drug showed consumers who would buy Oxytrol would be people who the drug was manufactured and intended for. Instead, they deemed Oxytrol would be potentially harmful to many consumers, especially to the elderly. There is also nothing to stop men from buying and using it as well.

OAB is a common disorder marked by urinary urgency and frequency which affects more than 20 million American women. An overactive bladder is a treatable condition, however more than 80 percent of women do not seek treatment.

Public Citizen notes that doctors often treat OAB with non-drug therapies and lifestyle modifications. Behavioral treatment can often reduce the number of incontinence episodes by approximately 8%, whereas Oxytrol reduces episodes by an average of 69%.

“Be very careful with this drug,” 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. “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.”