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.”
