November is Bladder Health Awareness Month - What's Your Bladder IQ?

Ongoing Conversations with a Doctor to Better Understand Bladder Function Can Impact Treatment Decisions about Common Bladder Health Issues

IRVINE, Calif., Nov. 5, 2013 /PRNewswire-USNewswire/ -- How frequently – or infrequently – we empty our bladders can be an indicator of a serious health issue,(1) yet, a recent survey found that nearly seven out of ten (69%) American women ages 45 or older may not recognize that passing urine more than eight times a day may be a signal of a bladder health problem.(2,3)  Bladder health issues are estimated to affect approximately 45 percent of the world's population ages twenty years or older,(4) yet, according to the survey, there are women that have yet to learn about their bladders.  The survey conducted by Allergan, Inc. and endorsed by the Women's Health Foundation, reports that almost two-thirds have never even had a discussion about their bladder health with a physician.(2)

"The results of the survey are of significant concern to me because while many bladder conditions, like overactive bladder, are common, they are by no means normal. Women should not have to settle for living with them as there are treatment options available," said Missy Lavender, Founder and Executive Director of the Women's Health Foundation, a non-profit organization dedicated to bringing education, funding and research to the field of women's pelvic health.

Overactive bladder, often referred to as OAB, is a common, sometimes disabling condition(5) that impacts an estimated 39 million Americans.(1) Characterized by symptoms such as strong need to urinate right away, frequent urination and, in many cases, strong need to urinate with leaking,(3) OAB can be confused with other health conditions involving frequent urination or the urge to urinate. Yet, according to the survey, only 27 percent of women say they would talk to their doctor about symptoms that could be an indicator of bladder health issues like OAB or another bladder health condition.(2)

"Women need to understand what is considered healthy and normal in terms of bladder health and to be proactive about talking to their doctors in order to get a proper diagnosis and to find the right treatment approach," said urologist Elizabeth Mueller, M.D., MSME, Associate Professor and Division Director of Female Pelvic Medicine and Reconstructive Surgery in the Departments of Urology and Obstetrics & Gynecology at Loyola University.  "Even if you have had a diagnosis of overactive bladder or another bladder health issue, it is important to continue an open dialogue with your doctor to ensure you are receiving the right treatment plan for you."   

With this in mind, the survey revealed that even if previously diagnosed and treated for OAB, only 35 percent of women would continue to engage in conversation with their physician if their ongoing symptoms like urine leakage or the urgency to go to the bathroom became unmanageable.(2) This is the case despite the fact that 73.5 (n=1,117) percent of patients stopped taking their OAB medication in one study within one year due to side effects and/or lack of results.(6)   

"Rather than simply foregoing treatment, women with bladder health concerns should talk with a specialist like a urologist or urogynecologist about other options.  Many of my patients have been surprised to learn that BOTOX® (onabotulinumtoxinA) is a treatment option to treat OAB symptoms in adults when another type of medication commonly used to treat OAB, known as anitcholinergics, does not provide the desired relief or has caused burdensome side effects," said Dr. Mueller. "BOTOX® takes another approach to targeting the source of OAB, the bladder muscle itself. It works by calming the nerves that trigger the overactive bladder muscle, which helps to reduce daily leakage episodes, treat the strong need to urinate right away and reduce the number of times needed to empty the bladder daily. For many of my patients, one treatment can last up to six months before the effects wear off."

In clinical studies, patients who had tried another type of OAB medication first and were then treated with BOTOX® experienced fewer daily leakage episodes in as little as two weeks.(7) By week 12, patients treated with BOTOX® had about three times fewer accidents than those who were not treated with BOTOX® and, on average, reduced their bathroom visits by two times a day. As with any medical treatment, it is important to discuss all of the potential side effects, as well as benefits of BOTOX®, with a doctor. In treating OAB, the most common side effects associated with BOTOX® are urinary tract infection (18 percent), painful or difficult urination (9 percent) and urinary retention (6 percent), which is a temporary inability to fully empty your bladder.(7)   Visit www.BOTOXforOAB.com to learn more about talking with a urologist or urogynecologist about OAB and to find a BOTOX® specialist.

About the Survey
The Overactive Bladder Survey was conducted by Kelton, a global insight and strategy firm, between April 12th and April 23rd, 2013 among 1,045 nationally representative American women ages 45 and older and an oversample to 528 American women ages 50+, using an email invitation and an online survey sent by Kelton.

BOTOX^® (onabotulinumtoxinA) Important Information

Indication
BOTOX® is a prescription medicine that is injected into the bladder muscle and used to treat overactive bladder symptoms such as a strong need to urinate with leaking or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency), and urinating often  (frequency) in adults 18 years and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken.

IMPORTANT SAFETY INFORMATION
BOTOX® may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX®:

• Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months
   
• Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing. If this happens, do not drive a car, operate machinery, or do other dangerous activities

Do not take BOTOX® if you: are allergic to any of the ingredients in BOTOX® (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.

Do not take BOTOX® for the treatment of urinary incontinence if you: have a urinary tract infection (UTI) or cannot empty your bladder on your own and are not routinely catheterizing.

Due to the risk of urinary retention (not being able to empty the bladder), only patients who are willing and able to initiate catheterization post-treatment, if required, should be considered for treatment. 

In clinical trials, 6.5% of patients (36/552) initiated clean intermittent catheterization for urinary retention following treatment with BOTOX® 100 Units as compared to 0.4% of patients (2/542) treated with placebo. 

Patients with diabetes mellitus treated with BOTOX® were more likely to develop urinary retention than non-diabetics.

The dose of BOTOX® is not the same as, or comparable to, another botulinum toxin product.

Serious and/or immediate allergic reactions have been reported. These reactions include itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get medical help right away if you experience any such symptoms; further injection of BOTOX® should be discontinued.

Tell your doctor about all your muscle or nerve conditions such as amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease), myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including severe dysphagia (difficulty swallowing) and respiratory compromise (difficulty breathing) from typical doses of BOTOX®.

Tell your doctor about all your medical conditions, including if you: have or have had bleeding problems; have plans to have surgery; had surgery on your face; weakness of forehead muscles, such as trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; have symptoms of a urinary tract infection (UTI) and are being treated for urinary incontinence. Symptoms of a urinary tract infection may include pain or burning with urination, frequent urination, or fever; have problems emptying your bladder on your own and are being treated for urinary incontinence; are pregnant or plan to become pregnant (it is not known if BOTOX® can harm your unborn baby); are breastfeeding or plan to breastfeed (it is not known if BOTOX® passes into breast milk).

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. Using BOTOX® with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® in the past.

Especially tell your doctor if you: have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin® in the past (be sure your doctor knows exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take anti-platelets (aspirin-like products) or anti-coagulants (blood thinners).

Other side effects of BOTOX® include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes. In people being treated for urinary incontinence other side effects include: urinary tract infection, painful urination, and/or inability to empty your bladder on your own. If you have difficulty fully emptying your bladder after receiving BOTOX®, you may need to use disposable self-catheters to empty your bladder up to a few times each day until your bladder is able to start emptying again.

For more information refer to the Medication Guide or talk with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see BOTOX® full Product Information including Boxed Warning and Medication Guide.

About the Women's Health Foundation
Women's Health Foundation (WHF) is a nonprofit organization dedicated to improving the pelvic health and wellness of women and girls through community-based programs and services, research, and events.  WHF is the nation's most visible and passionate champion of women's pelvic wellness issues.  Headquartered in Chicago, Women's Health Foundation programs run nationally.  To learn more, visit www.womenshealthfoundation.org.

About Allergan, Inc.
Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life's potential. Today, we have approximately 11,400 highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices and over-the-counter consumer products, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including eye care, neurosciences, medical aesthetics, medical dermatology, breast aesthetics, obesity intervention and urologics, Allergan is proud to celebrate more than 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work. For more information regarding Allergan, go to: www.allergan.com.

Forward-Looking Statements
This press release contains "forward-looking statements," including but not limited to the statements by Missy Lavender and Dr. Mueller, and other statements regarding the research and development, safety, efficacy, and adverse reactions associated with the use of BOTOX® for overactive bladder. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan's expectations and projections.  Risks and uncertainties include, among other things, general industry, biologic and pharmaceutical market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to new product marketing, such as the unpredictability of market acceptance for new pharmaceutical and biologics products, and the acceptance of new indications for such products; inconsistency of treatment results among patients; and governmental laws and regulations affecting domestic and foreign operations.  Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's most recent report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. Copies of Allergan's press releases and additional information about Allergan are available at www.allergan.com or you can contact the Allergan Investor Relations Department by calling 1-714-246-4636.

Allergan Contacts
Bonnie Jacobs   (856) 912-9965 (media), [email protected]
Heather Katt      (714) 697-2981 (media), [email protected]

© 2013 Allergan, Inc. Irvine, CA 92612. ® marks owned by Allergan, Inc. All rights reserved.

Myobloc® is a registered trademark of Solstice Neurosciences, Inc. 
Dysport® is a registered trademark of Ipsen Biopharm, Ltd.
Xeomin® is a registered trademark of Merz Pharma Gmbh & Co.

APC85AW13

(1) Stewart WF, Van Rooyen JB, Cundiff GW, et al. Prevalence and burden of overactive bladder in the United States. World J Urol 2003;20:327–336.
(2) Kelton OAB Quarterly Index Survey, Allergan, 2013, The Overactive Bladder Survey was conducted between April 12th and April 23rd, 2013 among 1,045 nationally representative American women ages 45 and older, using an email invitation and an online survey.
(3) The National Institute of Diabetes and Digestive and Kidney Diseases.(2007). What I need to know about Bladder Control for Women ( NIH Publication No. 07–4195). Bethesda, MD: National Institute of Diabetes and  Digestive and Kidney Diseases.
(4) Irwin DE, Kopp ZS, Agatep B, et al. Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction. BJU Int. 2011 doi: 10.1111/j.1464-410X.2010.09993.x.
(5) Tubaro A. (2004) Defining overactive bladder: epidemiology and burden of disease. Urology. 64(6 Suppl 1):2-6.
(6) D'Souza AO et al. J Manag Care Pharm. 2008;14(3):291-301.
(7) BOTOX® (onabotulinumtoxinA) Prescribing Information, updated January 2013.

SOURCE Allergan, Inc.