A Review of Drugs for Overactive Bladder

Patients should wait until 2015 before using fesoterodine (TOVIAZ), the most recently approved drug to treat overactive bladder, because it is not very effective and can have serious side effects.

In clinical trials, patients taking this drug urinated, on average, once less per day than those taking a placebo.

Fesoterodine, which the Food and Drug Administration (FDA) approved in 2008, is the sixth drug on the market approved to treat overactive bladder.

Anticholinergic side effects

As can be seen in the table on this page, all of the drugs currently approved in the U.S. to treat overactive bladder work about the same. The results are all statistically significant, and they are better than nothing, but their effect is minimal (a reduction of about one urination per day compared to a placebo).

Fesoterodine and the other drugs for managing overactive bladder (see Table) are known as anticholinergic agents. Anticholinergic effects are the result of a drug-induced blockage of the effects of acetylcholine, a natural substance produced by the body that has effects on many body functions (see Box at the beginning of the article), including facilitating urination.

Many patients experience a series of dangerous and uncomfortable side effects such as inhibited secretion of acid in the stomach; slowed passage of food through the digestive system; inhibited production of saliva, sweat and lung secretions; and increased heart rate and blood pressure.

The side effects of anticholinergic drugs thus include dry mouth, constipation, difficulty urinating and decreased sweating. Other effects are described in the Box on anticholinergic effects (above).

Unfortunately, these anticholinergic effects are both what makes them effective and what makes them potentially harmful. Although for patients with overactive bladder difficulty urinating is the intended effect of the drug, that same difficulty is, in a sense, a side effect of the drug. Taking more of the drug strengthens all of the side effects — including both the desired effects, such as reduced urination, and the ones you do not want.

These drugs should not be used in patients who have difficulty urinating, gastric retention (slowed passage of food through the digestive system, in this case the stomach) or narrow-angle glaucoma.

How fesoterodine compares with other overactive bladder drugs

The Table was constructed using the clinical trials reported in the professional product labels, or package inserts, of the drugs approved for overactive bladder treatment. These trials are the ones that were used by the FDA to approve these drugs.

What You Can Do

Do not use fesoterodine until it has been on the market for seven years, in 2015.

Urinary problems also may be caused by other drugs. Visit WorstPills.org for a list of drugs that cause urinary problems.

Patients should wait at least seven years from the date of release to take any new drug unless it is one of those rare "breakthrough" drugs that offers a documented therapeutic advantage over older, proven drugs.

New drugs are tested in a relatively small number of people before being released, and serious adverse effects or life-threatening drug interactions may not be detected until the new drug has been taken by hundreds of thousands of people.

A number of new drugs have been withdrawn within their first seven years after release. Also, warnings about serious new adverse reactions have been added to the labeling of a number of drugs, or new drug interactions have been detected, usually within the first seven years after a drug’s release.

Table. Comparative Effectiveness of Overactive Bladder Drugs

** Limited Use in "Worst Pills, Best Pills"
*** Do Not Use Until 2015 in "Worst Pills, Best Pills"