Advisory Committee Rejected Increased Availability but Was Ignored by FDA; Story Told in New Issue of Public Citizen’s Worst Pills, Best Pills News
WASHINGTON, D.C. – When a new over-the-counter (OTC) 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 advises in the latest edition of Worst Pills, Best Pills News (WorstPills.org), Public Citizen’s drug safety newsletter and website.
The manufacturer of oxybutynin (Oxytrol for Women), a drug for overactive bladder (OAB) 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, despite its risks. The OTC drug comes in the form of a patch applied to the skin.
The U.S. Food and Drug Administration (FDA) gave drug manufacturer Merck the green light to advertise and sell the drug for women over 18, overriding the recommendation of an advisory committee that said the drug should not 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: constipation, nausea and vomiting, difficulty swallowing, decreased sweating leading to heat-related injuries, difficulty urinating, increased heart rate, dry mouth, daytime sleepiness, blurred vision and impaired cognition. An uncommon but potentially life-threatening adverse reaction associated with the drug is angioedema, which causes swelling of the lips, tongue and lining of the throat, potentially leading to difficulty breathing and respiratory arrest.
OAB is a common chronic disorder of unknown cause occurring in both women and men, the symptoms of which include urinary urgency and frequency, including at night, and urge incontinence. For patients with such symptoms, a medical evaluation that includes urine tests should be performed to rule out other more serious conditions. For patients diagnosed with OAB, doctors recommend noninvasive, nondrug therapies and lifestyle modifications before turning to drugs such as oxybutynin. In fact, the first randomized 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 smaller 69 percent drop for oxybutynin-treated patients.
“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.”
When the FDA convened the Nonprescription Drugs Advisory Committee on Nov. 9, 2012, to consider whether an oxybutynin transdermal patch should be made available OTC, it considered the drug’s side effects and the question of “whether data presented by the drug’s manufacturer indicated that consumers who would purchase and use the OTC drug would be those for whom the drug is intended,” according to the Worst Pills, Best Pills article.
Six of 11 committee members voted “no,” to this question, implicitly advising the FDA not to approve the drug for OTC sale. They felt that the drug was unsafe for consumption by the elderly without a doctor’s approval, and that being sold OTC would lead consumers to use it as a first option and to underestimate its dangers.
Worst Pills, Best Pills Newsis a monthly newsletter available in print and electronic formats through Public Citizen’s subscription Web site, www.WorstPills.org. The article about oxybutynin will be available free for the next seven days. The site has other searchable information about the uses, risks and side effects associated with prescription medications.
WorstPills.org is an unbiased analysis of information compiled from well-regarded medical journals and, importantly, from unpublished data obtained from the FDA, that allows Public Citizen to regularly sound the alarm about potentially dangerous drugs long before they are eventually banned or restricted by the federal government, and to recommend safer drugs. For example, Public Citizen warned consumers about the dangers of Vioxx, ephedra, Baycol, Darvon, Meridia and Propulsid years before they were pulled from the market or, in the case of Avandia, severely restricted.