Two drugs for ‘Overactive Bladder’ Get FDA Approval
- 1 A drug that has been available by prescription only to help women with overactive bladder will soon be available over-the-counter (OTC).
- 2 Bladder Muscle Works Incorrectly
- 3 As with any medication — over-the-counter or prescription — it is important to contact your doctor if symptoms worsen or persist while using the product.
A drug that has been available by prescription only to help women with overactive bladder will soon be available over-the-counter (OTC).
The Food and Drug Administration (FDA) also approved the use of the product Botox (onabotulinumtoxinA) to treat overactive bladder in women and men who haven’t been helped by other medications.
The OTC drug, Oxytrol (oxybutynin), has been available for some time by prescription, and other medications to treat the disorder are available by prescription. However, it will be the first product available over-the-counter for overactive bladder.
Botox is an injection used for other indications, such as treating facial wrinkles, and it must be administered by a physician. For overactive bladder, it is injected directly into the bladder muscle, helping it to relax. It also helps increases bladder capacity.
Bladder Muscle Works Incorrectly
What is overactive bladder? Also referred to as “urge incontinence,” it is condition which causes the bladder muscle to squeeze too often or to squeeze without warning. You leak urine because your bladder muscles contract at the wrong times. Often these contractions occur no matter how much urine is in the bladder.
As a result, you may feel:
• a sudden urge to urinate that’s difficult to control
• an involuntary loss of urine immediately following an urgent need to urinate
• frequent urination, usually eight or more times in 24 hours
• awakening two or more times in the night to urinate
Overactive bladder affects about 33 million Americans, most of them older women. However, it is important to know that overactive bladder is not a normal part of aging. Treatments such as Oxytrol, Botox, and other medications help control symptoms, as do some non-drug treatments such as special exercises. And it is not only women who develop overactive bladder; men have it as well.
The causes of overactive bladder include:
• neurological disorders, such as multiple sclerosis
• producing a lot of urine, which can be caused by high fluid intake, or from taking certain medications such as diuretics
• having a urinary tract infection
• abnormalities in the bladder, such as tumors or bladder stones
• having a problem such as an enlarged prostate
• consuming too much caffeine or alcohol
Non-drug treatments for overactive bladder include:
• doing pelvic floor muscle “Kegel” exercises
• losing weight if you are overweight
• altering your fluid consumption
• “double voiding,” by emptying your bladder twice within a few minutes
• scheduling trips to the toilet at least every two hours
• “bladder training” to consciously delay urination for short intervals
Oxytrol is known as an “anticholinergic” drug, which is a class of medications that helps relieve spasms in smooth muscle. Over-the-counter, it will be available only in patch form, and is to be applied to the skin every four days.
Results of nine studies completed by the drug’s maker, Merck, in more than 5,000 women indicate that the drug is safe and effective. Side effects include mild skin irritation at the site of the patch, dry mouth, and constipation.
Oxytrol also may cause:
• blurred vision and drowsiness.
• an increase in certain side effects if taken with alcohol
• dehydration if you become overheated
People with these conditions should talk to their doctor before taking Oxytrol:
• liver disease
• kidney disease
• myasthenia gravis
• an enlarged prostate
• gastrointestinal disorders such as ulcerative colitis or gastroesophageal reflux disease (GERD)
Botox (made by Allergen) is usually given every 12 weeks.
Side effects of Botox include:
• urinary tract infections
• painful urination
• urinary retention
If urinary retention occurs after a Botox injection, you may need to use a catheter temporarily to pass urine. Your doctor may give you antibiotics before, during, and for a few days after Botox treatment to lower the chance of developing an infection from the procedure.
Prices for Botox are included in the cost of the injection procedure.
The prices for the Oxytrol OTC product are not yet available. But online prescription prices for the patches range from $73 for eight patches to $260 for 32 patches. A less-expensive generic form of Oxytrol is available in pill form by prescription only.
As with any medication — over-the-counter or prescription — it is important to contact your doctor if symptoms worsen or persist while using the product.
For more information, contact the FDA at: 888-INFO-FDA