FDA Approves Over-The-Counter Oxybutynin to Help Women Suffering From Overactive Bladder

This fall, newly approved over-the-counter (OTC) oxybutynin (OXYTROL FOR WOMEN) will be available for purchase, but the U.S. Food and Drug Adminstration (FDA) is urging women to check with their doctors before using Oxytrol).

Merck, the manufacturer of Oxytrol, can look to see an increase in sales thanks to this OTC oxybutynin patch – applied to the skin – which is the first FDA-approved OTC drug used to treat overactive bladder (OAB) symptoms and urinary incontinence in women. Prescription versions of oxybutynin have been available to treat these symptoms since 1975, but never has an over-the-counter version been available, until now.

Although a slim majority of an advisory committee objected to the approval of this OTC oxybutynin on January 15, 2013, the FDA decided to pass its approval anyway. Oxybutynin is part of a family of drugs known as anticholinergics, which generally should be avoided by elderly women, especially women with cognitive impairments or dementia.

There are several different options when it comes to prescription oxybutynin, such as a once-daily, controlled-release tablet, called Ditropan XL. There is a once-daily topical gel applied to the skin, called Anturol, Gelnique; and there is a transdermal patch (Oxytrol), applied twice a week to the skin. This patch dishes out 3.9 mg of oxybutynin each day, and the OTC version of oxybutynin patch is also transdermal, applied every four days and delivering the same dose as the prescription patch.

Each formulation of anticholigeneric drugs may cause numerous side effects, most of which stem from blocking the action of acetyclcholine in other organs of the body beyond the bladder. However, the most commonly-noted side effects of anticholinergics are:

  • Dry mouth caused by decreased saliva production;
  • Nausea and vomiting;
  • Increased heart rate and palpitations;
  • Constipation due to slowed passage of food through the digestive system;
  • Difficulty swallowing;
  • Daytime sleepiness;
  • Difficulty urinating because of the effects on bladder muscles;
  • Impaired cognition;
  • Decreased sweating, which can lead to heat stroke and other heat-related injuries; and
  • Impaired cognition.

It is important to note that, although uncommon, another reported adverse reaction associated with oxybutynin is a potentially life-threatening side effect called angioedema, which causes swelling of the lips, tongue, and lining of the throat. It may also lead to obstruction of the windpipe, which is the airway to the lungs, which results in difficulty breathing and, in severe cases, respiratory arrest.

But there aren’t all negative connotations when dealing with oxybutynins. When the first versions of prescription oxybutynin transdermal patches became available in 2003, there was a lot of buzz about the fact that there was finally an option which would keep the levels of the drug stable, as opposed to the ups and downs associated with the intermittent side effects of the oral versions.

However, the advantages of the patch version, which limits the side effects, are negated in the sense that the patch formulation is less effective than the oral versions.

Earlier, we mentioned that a slim majority of the advisory committee objected to the approval of OTC oxybutynin. Their major concerns were the increased risk in elderly patients. Additionally, they were concerned that the public would perceive the OTC drug as a safer alternative, since the nature of all OTC drugs means that there is no need to consult with a doctor before taking the drug.  Finally, the advisory committee was worried about incorrect use of the OTC product, noting that patients may not be able to tell the difference between OAB and other similar conditions, such as a bladder infection.

Although we recommend consulting with a doctor before using OTC oxybutynin, we will explain the symptoms of OAB so that you have a better understanding of how to detect it. OAB is a common chronic disorder of unknown cause that occurs in both women and men. Some common symptoms are urinary urgency (having a strong need or urge to urinate immediately), urinary frequency (needing to urinate more often than normal, usually over 10 times a day), nocturia (needing to use the bathroom over two times during the night), and urge incontinence (in ability to control the urge to urinate, causing leakage of urine).

These symptoms and side effects range from mild to severe, and are caused by frequent, abnormal spasms or contractions inside the muscles within the bladder walls, often when the bladder is only partially filled with urine.

Theses symptoms are not life-threatening, but can cause embarrassment and adversely effect the quality of living. Before taking to drug therapy, those suffering from OAB should always start with noninvasive, nondrug therapies, such as smoking cessation, reduction of caffeine and alcohol intake, limiting fluid intake, and weight loss. Additionally, behavioral interventions such as pelvic floor muscle training, bladder training, and lifestyle modifications are recommended.

When symptoms still persist, a visit with your doctor to discuss oxybutynin drug treatment may be beneficial. Oxybutynin works by blocking the effects of acetylcholine, a substance produced by nerves in the body that control a variety of bodily functions. Acetylcholine causes the muscle of the bladder to contract, so the blockage of acetylcholine by taking drugs such as oxybutynin causes the bladder muscles to relax.

Once your doctor has determined that you suffer from OAB, and that behavioral interventions and other noninvasive treatments have not helped, you may be eligible to begin OTC oxybutynin treatment. However, you should not take OTC or prescription oxybutynin without consulting with your doctor first, and you should not take either version of oxybutynin if you are pregnant, have had allergic reactions to the drug, or have urinary retention, gastric retention, or narrow-angle glaucoma.

Once you start taking OTC oxybutynin, you should read the drug label to be aware of the side effects. Additionally, you should discontinue drug use and seek urgent medical attention if you experience swelling of the lips, tongue, or throat. You also should not operate a motor vehicle or heavy machinery until you know how oxybutynin affects you.

Feel free to comment on this blog post. For more information, contact a Gacovino Lake attorney at 1-800-246-HURT (4878).

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