BOTOX Approved To Treat Overactive Bladder In Adults.

BOTOX, onabotulinumtoxinA

FDA has approved BOTOX, onabotulinumtoxinA to treat over active bladder problem in adult patients. These patients do not react well or respond to treatments known as anticholinergics. The treatment includes injecting bladder muscle with BOTOX, which causes bladder to relax and increase the storage capacity. The procedure is performed using Cystoscopy allowing doctors to see the interior of the bladder during the treatment. The patients benefit from BOTOX injections with reduced episodes of urinary incontinence.
The procedure can be repeated when the benefits of the previous treatment begin to decrease but an interval of at least 12 weeks should lapse between each treatment.
Following is the press release by FDA;

The U.S. Food and Drug Administration today expanded the approved use of Botox (onabotulinumtoxinA) to treat adults with overactive bladder who cannot use or do not adequately respond to a class of medications known as anticholinergics.
Overactive bladder is a condition in which the bladder squeezes too often or squeezes without warning. Symptoms include leaking urine (urinary incontinence), feeling the sudden and urgent need to urinate, and frequent urination.
When Botox is injected into the bladder muscle, it causes the bladder to relax, increasing the bladder’s storage capacity and reducing episodes of urinary incontinence. Injecting the bladder with Botox is performed using cystoscopy, a procedure that allows a doctor to visualize the interior of the bladder while Botox is being injected.
“Clinical studies have demonstrated Botox’s ability to significantly reduce the frequency of urinary incontinence,” said Hylton V. Joffe, M.D., director of the Division of Reproductive and Urologic Products in FDA’s Center for Drug Evaluation and Research. “Today’s approval provides an important additional treatment option for patients with overactive bladder, a condition that affects an estimated 33 million men and women in the United States.”
Botox’s safety and effectiveness for this new indication were established in two clinical trials of 1,105 patients with symptoms of overactive bladder. Patients were randomly assigned to receive injections of 100 units of Botox (20 injections of 5 units each) or placebo.
Results after 12 weeks showed that patients treated with Botox experienced urinary incontinence an average of 1.6 to 1.9 times less per day than patients treated with placebo. Botox-treated patients also needed to urinate on average 1.0 to 1.7 times less per day and expelled an average of about 30 milliliters more urine than those treated with placebo.
Treatment with Botox can be repeated when the benefits from the previous treatment have decreased, but there should be at least 12 weeks between treatments.
Common side effects reported during clinical trials included urinary tract infections, painful urination, and incomplete emptying of the bladder (urinary retention). Patients who develop urinary retention may need to use a catheter until the urinary retention resolves. Patients being treated for overactive bladder with Botox should not have a urinary tract infection and should take antibiotics before, during, and for a few days after Botox treatment to lower the chance of developing an infection from the procedure.
Botox is manufactured by Allergan Inc. based in Irvine, Calif.
For more information:
FDA Approved Drugs: Questions and Answers 

Adverse Reactions Linked to Botox Use With Regards to Ongoing safety review of Botox, Botox Cosmetic and Myobloc By FDA

FOR IMMEDIATE RELEASE February 8, 2008

Media Inquiries: Sandy Walsh, 301-827-3418 Consumer Inquiries: 888-INFO-FDA

FDA Notifies Public of Adverse Reactions Linked to Botox Use
Ongoing safety review of Botox, Botox Cosmetic and Myobloc taking place

The U.S. Food and Drug Administration today notified the public that Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) have been linked in some cases to adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses.

In an early communication based on the FDA's ongoing safety review, the agency said the reactions may be related to overdosing. There is no evidence that these reactions are related to any defect in the products.

The adverse effects were found in FDA-approved and nonapproved usages. The most severe adverse effects were found in children treated for spasticity in their limbs associated with cerebral palsy. Treatment of spasticity is not an FDA-approved use of botulism toxins in children or adults.

The adverse reactions appear to be related to the spread of the toxin to areas distant from the site of injection, and mimic symptoms of botulism, which may include difficulty swallowing, weakness and breathing problems.

The FDA is not advising health care professionals to discontinue prescribing these products.

The agency is currently reviewing safety data from clinical studies submitted by the drugs' manufacturers, as well as post-marketing adverse event reports and medical literature. After completing a review of the data, the FDA will communicate to the public its conclusions, resulting recommendations, and any regulatory actions.

The notification is in keeping with the FDA's commitment to inform the public about its ongoing safety reviews of drugs. The early communication, which includes background information and advice for health care professionals, can be viewed at: http://www.fda.gov/cder/drug/early_comm/botulinium_toxins.htm

tag: FDA Advisory, Botox, Myobloc, Botox Cosmetic, Botulinum toxin, Botulinum toxin Type B, cerebral palsy, spasticity,