Saturday November 1, 2008 (foodconsumer.org) – The U.S. Food
and Drug Administration announced on Friday that it had approved a new
treatment called Toviaz (fesoterodine fumarate) to help patients suffering from
overactive bladder or OAB.
Overactive bladder (OAB) is a urological condition that
causes abnormal urination with symptoms including increased urinary frequency,
urge to urinate and leakage of urine.
Toviaz manufactured by Schwarz Pharma of Zwickau, Germany
and distributed by Pfizer Inc. of New York, N.Y. works by relaxing the smooth
muscle tissue of the bladder, according to the FDA.
Common treatments for OAB include diet modification,
bladder retraining, antimuscarinic drugs and various devices, wikipedia
Intravesical botulinum toxin A is
also used in some cases although the FDA did not formally approve the therapy.
"This new drug will provide an additional treatment
option to help them manage problems with an overactive bladder." said
George Benson, M.D., deputy director, Division of Reproductive and Urologic
Products at the FDA’s Center for Drug Evaluation and Research.
Toviaz will be available by prescription only for adults,
sold in forms of tablets with 4 mg or 8 mg dosages and administrated once a day,
the FDA said.
The drug was approved based on data on its safety and efficacy
obtained from two 12-week trials of a total more than 1500 patients of whom the
majority was female and aged 58 years on average.
The FDA said in its announcement that in each of those
two studies, Toviaz showed statistically significant and clinically meaningful
improvement in decreasing the number of times patients needed to urinate per
day and also the number of urine leaking episodes each day.
Like all medications, Toviaz causes side effects
including dry mouth and constipation, less commonly dry eyes and trouble
emptying the bladder.
The FDA warned that this medication is not recommended in
doses above 4 mg for patients with severe reduction in kidney function, those
patients taking certain medications and those who suffer from decreased
gastrointestinal motility, such as those with severe constipation.
Disclaimer: What's published on this website should be considered opinions of respective writers only and foodconsumer.org which has no political agenda nor commercial ambition may or may not endorse any opinion of any writer. No accuracy is guaranteed although writers are doing their best to provide accurate information only.
The information on this website should not be construed as medical advice and should not be used to replace professional services provided by qualified or licensed health care workers. The site serves only as a platform for writers and readers to share knowledge, experience, and information from the scientific community, organizations, government agencies and individuals.
Foodconsumer.org encourages readers who have had medical conditions to consult with licensed health care providers - conventional and or alternative medical practitioners.