New Drug OK'd for Overactive Bladder

(November 2, 2008) - There will soon be a new drug on the market for people with overactive bladders (OAB). The U.S. Food and Drug Administration has approved a new drug called Toviaz (fesoterodine fumarate). It works by relaxing the smooth muscle tissue of the bladder, thus reducing the urinary frequency, urge to urinate, and sudden urinary incontinence (leakage of urine), that are characteristic symptoms of OAB. (Read about "Incontinence")

"Patients who suffer from overactive bladder face quality of life issues that can hamper their ability to enjoy life to its fullest," said George Benson, M.D., deputy director, Division of Reproductive and Urologic Products at the FDA's Center for Drug Evaluation and Research. "This new drug will provide an additional treatment option to help them manage problems with an overactive bladder."

Toviaz will be available by prescription only, as an extended release tablet in either 4 mg or 8 mg dosage strengths. It is to be taken once daily. The recommended starting dose is 4 mg, which can be increased to 8 mg if needed, based upon how and individual reacts to the drug. Toviaz is only approved for adults.

The drugs comes with a number of precautions. Common side effects associated with Toviaz included dry mouth and constipation. (Read about "Constipation") Less frequently reported side effects included dry eyes and trouble emptying the bladder.

Toviaz is not recommended in doses above 4 mg in those patients with severe reduction in kidney function (Read about "Kidney Disease") or in those patients taking medications, such as ketoconazole, that block the metabolism of the drug. It should not be used in patients who suffer from urinary or gastric retention or in patients with uncontrolled, narrow-angle glaucoma. (Read about "Glaucoma") It should also not be used in patients with severe liver impairment. (Read about "The Liver") The product should be used with caution in patients who suffer from decreased gastrointestinal motility, such as those with severe constipation.