Bladder Control Drug now Available Without Prescription
Info provided from the MS Foundation
A patch
containing oxybutynin (Oxytrol®) for controlling overactive bladder may now be
sold over-the-counter (OCT) for women 18 and older, according to the U.S. Food
and Drug Administration. The medication is one that has been prescribed for
over-active bladder due to MS. Men will continue to need a prescription for the
drug, the agency said.
Ben Thrower,
M.D., senior medical advisor for the MSF, advises: “Women in this
situation should still discuss their bladder symptoms with their MS healthcare
provider. Medications like Oxytrol need to be used with appropriate guidance.”
The OTC
product will be marketed by Merck as Oxytrol for Women.
Oxybutynin is an anticholinergic agent that acts as a bladder muscle relaxant.
No agent in this class has been available over-the-counter before, according to
the FDA.
The approval
comes despite an agency advisory panel’s narrow vote against the OTC
switch in November. Panel members expressed concerns about inappropriate use of
the drug without a physician’s oversight or diagnosis of overactive bladder.
Approval of the OTC formulation was supported by nine studies in more than
5,000 participants.
“Overall,
results from these studies showed that consumers can understand the information
on the label, properly select whether the product is right for them, and use
the drug appropriately,” the FDA said.
Adverse
effects seen in these studies included mild skin irritation at the patch site,
dry mouth, and constipation. Merck’s studies also found that men were
relatively poor at correctly determining whether oxybutynin was the appropriate
treatment for their urination problems. A key worry is that incorrect
self-diagnosis in men could delay detection of prostate cancer. Consequently,
the company did not seek OTC status for the product in men.
..