IRVINE, Calif., June 18, 2013 /PRNewswire-USNewswire/ -- Women are frequently the healthcare advocate for their loved ones or families, but unfortunately they often do not give the same priority to their own health. One in five women have kept information from their doctor because they were too embarrassed or too nervous to speak about it, according to a recent survey conducted by Allergan and endorsed by the Women's Health Foundation, a non-profit organization dedicated to bringing education, funding and research to the field of women's pelvic health.1 The survey, which consisted of more than 1,000 women ages 45+, also revealed that approximately two-thirds of women have never had a discussion with their doctor about their bladder health, a common, yet sometimes "embarrassing" topic.1
"An estimated 39 million Americans have overactive bladder (OAB),2 and 40 percent of all women in the United States live with OAB symptoms,3" said Missy Lavender, Founder and Executive President of the Women's Health Foundation. "These women often worry about having an accident and mapping out bathrooms wherever they go. Unfortunately, many settle for living with the condition in secret and are even reluctant to tell their doctors when their medicine no longer works for them. We encourage women to arm themselves with information, push aside their embarrassment and have a discussion with a urologist or urogynecologist to find the right treatment option for them."
Only 27 percent of women surveyed noted that they would immediately call their doctor to schedule an appointment if they were experiencing symptoms of OAB such as urine leakage or the frequent urge to go to the bathroom.1 When women do talk to their physicians about OAB, they may receive a prescription for pills to manage their symptoms. In one study, the majority of patients (73.5 percent), however, stopped taking their pills within one year due to side effects and/or lack of results.4 Specialists, such as urologists and urogynecologist, can offer other treatment options such as BOTOX® (onabotulinumtoxinA), which was approved by the U.S. Food and Drug Administration earlier this year for the treatment of OAB with symptoms of urinary leakage, urgency and frequency, when an oral medication (anticholinergic) does not work well enough or causes burdensome side effects.
"My patients often come to me after trying other treatment options and are frustrated that they haven't been able to find desired relief from their OAB symptoms such as leakage," said Dr. Elizabeth Mueller, MD, MSME, associate professor and division director of Female Pelvic Medicine and Reconstructive Surgery in the Departments of Urology and Obstetrics & Gynecology at Loyola University. "While I appreciate that talking about bladder leakage may be embarrassing, there are options after pills. Treatment options, like BOTOX®, may provide relief for those who have tried another OAB medication and are still frustrated. The more honest conversations I have with my patients, the better equipped I am to work with them to find the right treatment approach."
BOTOX® (onabotulinumtoxinA) takes another approach to targeting the source of OAB, the bladder muscle, and works by calming the nerves that trigger the bladder muscle. In clinical studies, one BOTOX® treatment provides up to six months of improvement of OAB symptoms. Patients treated with BOTOX® experienced about three times fewer accidents than those who were not treated with BOTOX® by week 12 and, on average, patients who received BOTOX® reduced their bathroom visits by two times a day.5 As with any medical treatment, it's important to talk to a doctor about all of the potential side effects, as well as benefits. 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.5 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 approved to treat overactive bladder symptoms, such as a strong need to urinate with leakage, urgency and frequency in adults when another type of medication (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. The median duration of catheterization for these patients treated with BOTOX® 100 Units was 63 days (minimum 1 day to maximum 214 days) as compared to a median duration 11 days (minimum 3 days to maximum 18 days) for patients receiving 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.
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 11,100 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.
This press release contains "forward-looking statements," including but not limited to the statements by Missy Lavender and Dr. Elizabeth Mueller, and other statements regarding the research and development, safety, efficacy, adverse reactions and other statements associated with BOTOX® for the use of 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/or 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.
© 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.
1 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.
2 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.
3 Urology Care Foundation, the official foundation of the American Urological Association. Overactive Bladder Web page: http://www.urologyhealth.org/urology/index.cfm?article=112. Accessed May 23, 2013.
4 D'Souza AO et al. J Manag Care Pharm. 2008;14(3):291-301.
5 BOTOX® (onabotulinumtoxinA) Prescribing Information, updated January 2013.
SOURCE Allergan, Inc.