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New Drug Approved for Overactive Bladder
Oct. 31, 2008 -- The FDA has approved a new prescription drug called Toviaz to treat overactive bladder (OAB) in adults.
Toviaz relaxes the bladder's smooth muscle tissue, 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. This new drug will provide an additional treatment option to help them manage problems with an overactive bladder," George Benson, MD, says in a news release. Benson is the deputy director of the Division of Reproductive and Urologic Products at the FDA's Center for Drug Evaluation and Research.
Toviaz, which is taken once daily, will be available as an extended-release tablet in doses of 4 or 8 milligrams. The recommended starting dose is 4 milligrams, which can be increased to 8 milligrams if needed, based upon individual response and tolerability, according to the FDA.
The FDA approved Toviaz based on two studies, each lasting 12 weeks. Together, the studies included 554 patients who took either the 4-milligram dose, the 8-milligram dose, or a placebo. Toviaz trumped the placebo at reducing the number of times per day that patients leaked urine or needed to urinate.
According to the FDA, 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 doses higher than 4 milligrams aren't recommended for patients with severe reduction in kidney function or people taking medications, such as ketoconazole, that block metabolism of Toviaz.
Toviaz shouldn't be used by patients who suffer from urinary or gastric retention, patients with uncontrolled, narrow-angle glaucoma, or patients with severe liver impairment. Toviaz should be used with caution in patients who suffer from decreased gastrointestinal motility, such as those with severe constipation.
Consumers or health care professionals may report any side effects or product quality problems with Toviaz to the FDA's MedWatch Adverse Event Reporting program.
Toviaz is made by Schwarz Pharma of Zwickau, Germany, and is distributed by the drug company Pfizer.
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Indication
Uroxatral® (alfuzosin HCl 10 mg extended-release tablets) is an alpha1-blocker for the treatment of the signs and symptoms of BPH.
Important Safety Information
Do not take UROXATRAL if you have liver problems or if you are taking antifungal drugs like ketoconazole or itraconazole, or HIV drugs like ritonavir.
UROXATRAL can cause a sudden drop in blood pressure, especially when starting treatment. This may lead to fainting, dizziness, and lightheadedness. Do not drive, operate machinery, or do any dangerous activity until you know how UROXATRAL will affect you. This is especially important if you already have a problem with low blood pressure or take medicines to treat high blood pressure. There may be an increased risk of low blood pressure and fainting when taking UROXATRAL in combination with blood pressure medication or nitrates, or erectile dysfunction medication.
If considering cataract surgery (clouding of the eyes), tell your eye surgeon that you are currently taking UROXATRAL or have previously been treated with an alpha-blocker.
Before taking UROXATRAL, tell your doctor if you have kidney problems.
Also, tell your doctor if you or any family member(s) have or take medications for a rare heart condition known as congenital prolongation of the QT interval.
BPH and prostate cancer can cause the same symptoms. However, UROXATRAL is not a treatment for prostate cancer.
The most common side effects with UROXATRAL are dizziness, upper respiratory tract infection, headache, and tiredness.
Please see UROXATRAL full prescribing information.
