Complain about a product or service

FDA Approves New Overactive Bladder Drug

Toviaz to be offered in 4 or 8 mg doses

November 3, 2008

• Study Links Prostate Cancer to Single Rogue Cell • PSA Testing May Be Unnecessary for Some Older Men • Compound Can Identify Prostate Cancer • Improved PSA Tests May Better Determine Prostate Cancer Risk • Vitamins Don't Cut Prostate Cancer Risk • Aspirin May Lower PSA Levels in Men • FDA Approves New Overactive Bladder Drug • New Prostate Surgical Techniques Often "Over-Promoted" • Feds Approve Drug for Enlarged Prostate • New Prostate Cancer Treatment Shows Promise • Broccoli Reduces Prostate Cancer Risk, Study Finds • Celebrex-Lipitor Combo May Halt Prostate Cancer • Exercise May Speed Prostate Tumor Growth • Soy Compound May Halt Spread of Prostate Cancer • Obesity Linked to Higher Prostate Cancer Mortality • Red Wine May Fight Prostate Cancer • Enlarged Prostate Doesn't Mean Cancer • Hopkins Researchers Claim Better Blood Test for Prostate Cancer • Severe Form of Enlarged Prostate Disease Discovered • Tomato-Broccoli Combo Can Help Shrink Prostate Cancers • Weight Gain Increases Risk of Dying from Prostate Cancer • Smoking Linked to Complications in Prostate Cancer Treatment • Newer Approach Urged in Screening for Aggressive Prostate Cancer • Aspirin May Prevent or Delay Enlarged Prostate • Hopkins Researchers Find Better Blood Test for Prostate Cancer • Prostate Radiation May Cause Problems Later • New Test Detects Prostate Cancer Spread Earlier • Castration May Be Advised in Advanced Prostate Cancer • Radiation Therapy May Be Best for Younger Prostate Cancer Patients • Study Recommends More Prostate Biopsies • Delayed Surgery May Be OK for Some Prostate Cancer Patients • Study: PSA Test Doesn't Improve Prostate Cancer Survival Rate • Prostate Cancer Genes Identified • Annual Prostate Cancer Screening Test Appears to Save Lives • FDA Panel Rejects Prostate Cancer Pill • PSA Test Still Useful, Hopkins Study Finds • No "Normal" PSA Level: Study • New Prostate Cancer Test Shows Promise • Lifestyle and Diet May Stop or Reverse Prostate Cancer Progression

The U.S. Food and Drug Administration (FDA) has approved Toviaz, a new drug to help relieve symptoms of an overactive bladder. The drug, whose generic name is fesoterodine fumarate, works by relaxing the smooth muscle tissue of the bladder, thus reducing the urinary frequency, urge to urinate, and sudden urinary incontinence, that are characteristic symptoms of OAB.

"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 administered once daily.

The recommended starting dose is 4 mg, which can be increased to 8 mg if needed, based upon individual response and tolerability. Toviaz is only approved for adults.

The safety and effectiveness of Toviaz were studied in two, 12-week, randomized controlled studies of the 4 mg and 8 mg doses. For the combined studies, a total of 554 patients received placebo, 554 patients received Toviaz 4 mg daily, and 566 patients received the drug 8 mg daily. The majority of patients were female with a mean age of 58 years. Toviaz is not approved for pediatric use.

In each of those two studies, the FDA said the product showed a statistically significant and clinically meaningful improvement in decreasing the number of times patients needed to urinate per day, as well as the number of urine leaking episodes they experienced per day, as compared to placebo.

Common side effects associated with Toviaz included dry mouth and 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 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. It should also not be used in patients with severe liver impairment. The product should be used with caution in patients who suffer from decreased gastrointestinal motility, such as those with severe constipation.

Toviaz is manufactured by Schwarz Pharma of Zwickau, Germany and is distributed by Pfizer Inc.

Report Your Experience
If you've had a bad experience -- or a good one -- with a consumer product or service, we'd like to hear about it. All complaints are reviewed by class action attorneys and are considered for publication on our site. Knowledge is power! Help spread the word. File your consumer report now.

Share		Follow us on Twitter.