FDA OK’s First OTC Remedy For Overactive Bladder

92 FDA OKs First OTC Remedy For Overactive BladderWebMD Medical News

Reviewed by Laura J. Martin, MD

Jan. 25, 2013 — The FDA has approved Oxytrol for Women, the first over-the-counter treatment for overactive bladder in women 18 and older.

The condition affects more than 20 million American women, according to Merck, the drug’s manufacturer.

It will still only be available in prescription form for men.

Oxytrol helps relax the overactive bladder muscle that leads to symptoms such as the sudden need to urinate and leaking of urine.

Oxytrol for Women is in the form of a patch, applied to the skin every four days, Merck says.

It is expected to hit store shelves by the fall. No cost estimates are yet available, according to Merck.

Oxytrol in pill form by prescription will still be available. Oxytrol for Women contains oxybutynin, a drug that helps to relax the bladder muscle. It belongs to a class of drug called anticholinergics. It is the first of this class to go over-the-counter for overactive bladder treatment.

Each patch delivers 3.9 milligrams of the drug every day.

The FDA approved the drug after reviewing its safety and effectiveness in nine studies involving more than 5,000 women. According to the FDA, the study participants could understand the label information and use the drug appropriately.

Among side effects reported in the studies were skin irritation at the site of the patch, constipation, and dry mouth. Merck will supply an educational leaflet with the product.

Most women who develop overactive bladder are 45 to 60 years old. Many do not seek professional medical help due to embarrassment.

According to the National Association for Continence, those who suffer with bladder problems wait on average seven years before seeking treatment.

Among other prescription medications for the condition are fesoterodine (Toviaz),  solifenacin (Vesicare) and tolterodine (Detrol).

Bladder training and pelvic floor exercises are other common treatment options.

Comments

More From CBS Tampa

Tampa Considers Food Donations to Pay Off Parking TicketsLooking for a way out of a parking ticket? Donate some canned goods to a food bank.
Containment | Tuesdays at 9pm on CW44From Executive Producer Julie Plec, "Containment" premieres April 19th at 9pm on CW44!
Wednesday’s Work-Out of the Day (3/23)It’s the time we’ve all been waiting for ladies and gentleman. Spring season is finally upon us which means more fun in the sun and scheduled beachfront vacations. Many college students anticipate spring break year-round and have ample time to prepare their bodies and get into shape.

Listen Live