Welcome! We regret to inform you that the Injury Board National News Desk has been discontinued. Feel free to browse around and enjoy our previously published articles, or visit The Injury Blog Network for the latest in personal injury news.

Toviaz Approved By The FDA For Overactive Bladder

Posted by Chrissie Cole
Sunday, November 02, 2008 11:23 PM EST
Category: Major Medical
Tags: FDA and Prescription Drugs, Toviaz, Schwarz Pharma, Pfizer, Overactive Bladder, Urinary Incontinence


IMAGE SOURCE: © Toviaz, distributed by Pfizer Inc.

The U.S. Food and Drug Administration (FDA) has approved Toviaz, extended relief tablets - a new prescription drug to treat overactive bladder (OAB) in adults.

Toviaz (fesoterodine fumarate) works by relaxing the bladder’s smooth muscle tissue, thereby reducing urinary frequency and leakage of urine which are classic symptoms of OAB.

Overactive bladder is a bothersome medical condition affecting more than one in six Americans, yet it still remains highly under treated.

Toviaz, available by prescription only, is taken once-daily in doses of 4 or 8 milligrams. Typical starting dosage is 4 mg, which can be increased to 8 mg, based on patient response and tolerability, according to the FDA.

The safety and effectiveness of Toviaz was studied in two large 12-week Phase III clinical studies of 1,964 OAB patients. Patients showed up to an 88 percent median reduction in urinary incontinence with Toviaz 8 mg versus 50 percent with placebo.

Treatment with Toviaz 8 mg showed a statistically significant improvement in lessening the amount of times patients needed to urinate daily (up to 19 percent), as well as the number urine leaking episodes experienced each day, compared to the placebo (11 percent).

Common side effects of use include: dry mouth and constipation, according to the FDA. Less commonly reported side effects include trouble emptying the bladder and dry eyes.

Toviaz in dosages higher than 4 mg is not recommended for patients with severe reduction in kidney function or those people taking medications, such as ketoconazole, that block metabolism of Toviaz.

Some people should not Toviaz, including patients with severe liver impairment, gastric retention or uncontrolled, narrow-angle glaucoma, the FDA said.

Any serious adverse events (side effects) can be reported by consumers and/or health care professionals to the FDA’s MedWatch Adverse Event Reporting Program.

Toviaz is made by Schwarz Pharma and distributed by Pfizer. It is expected to be available in the U.S. in early 2009. #

No Comments

Comments for this article are closed.

About the National News Desk

Our mission is to seek the complete truth and provide a full and fair account of the events and issues that surround personal safety, accident prevention, and injury recovery.  We are committed to serving the public with honesty and integrity in these efforts.

Hurt in an accident? Contact an Injury Board member

Subscribe to Blog Updates

Enter your email address if you would like to receive email notifications when comments are made on this post.

Email address


RSS Feed

Add the National News Desk to your favorite RSS reader

Add to Google Reader Add to myYahoo Add to myMSN Add to Bloglines Add to Newsgator Add to Netvibes Add to Pageflakes