25.01.2008 00:25:00
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Allergan, Inc. Comments on BOTOX(R) (Botulinum Toxin Type A) Safety Profile
Allergan, Inc. (NYSE: AGN) today commented on a petition filed by Public
Citizen yesterday with the U.S. Food and Drug Administration (FDA)
suggesting additional label changes and a written communication to
physicians regarding botulinum toxin products.
The petition addresses all botulinum toxins approved in the United
States and relates to labeling matters involving numerous botulinum
toxins marketed globally. Every botulinum toxin is unique and has its
own safety and efficacy profile. Allergan can only comment on its own
products, BOTOX® and
BOTOX® Cosmetic
(botulinum toxin type A) (collectively referred to in this press release
as "BOTOX®”).
There are no safety issues raised in the petition that are not already
addressed in the labeling for BOTOX®.
Allergan takes its FDA-mandated labeling obligations very seriously. The
current label for BOTOX®
provided to physicians in the United States provides detailed
information and appropriate guidance on the proper uses of BOTOX®,
including detailed directions for approved medical uses,
contraindications, warnings, precautions, drug interactions, and
reported adverse event information.
Allergan is in frequent dialog with the FDA to ensure proper labeling
for its products and also submits information on all adverse events that
are received whether or not they are considered related to the drug. In
collaboration with the FDA and other regulatory agencies around the
world, Allergan regularly reviews safety information and updates the
labels for its products as appropriate.
BOTOX® has a
long-established safety profile and has been approved by the FDA for
more than 17 years to treat a variety of medical conditions, as well as
for aesthetic use (glabellar lines) since 2002. With more than 3,000
publications on botulinum toxin type A in scientific and medical
journals, results of dozens of clinical trials involving more than
10,000 patients, and having been used in clinical practice to treat more
than a million patients worldwide, BOTOX®
is a widely researched medicine. BOTOX®
has been approved for 20 indications in more than 75 countries and is
prescribed to patients who suffer from a range of serious or
debilitating disorders, as well as to those with aesthetic needs.
For any medical inquiries related to the proper use of BOTOX®,
please contact Allergan’s Medical Information
Department at 1-800-433-8871.
Important BOTOX®
and BOTOX®
Cosmetic (Botulinum Toxin Type A) Information
BOTOX® is indicated
for the treatment of cervical dystonia in adults to decrease the
severity of abnormal head position and neck pain associated with
cervical dystonia.
BOTOX® is also
indicated for the treatment of strabismus and blepharospasm associated
with dystonia, including benign essential blepharospasm or VII nerve
disorders in patients 12 years of age and above.
The efficacy of BOTOX®
treatment in deviations over 50 prism diopters, in restrictive
strabismus, in Duane’s syndrome with lateral
rectus weakness, and in secondary strabismus caused by prior surgical
over-recession of the antagonist has not been established. BOTOX®
is ineffective in chronic paralytic strabismus except when used in
conjunction with surgical repair to reduce antagonist contracture.
And BOTOX® is
indicated for the treatment of severe primary axillary hyperhidrosis
that is inadequately managed with topical agents.
BOTOX® Cosmetic is
approved for the temporary treatment of moderate to severe frown lines
between the brows in people ages 18-65.
Important BOTOX®
and BOTOX®
Cosmetic (Botulinum Toxin Type A) Safety Information
BOTOX® and BOTOX®
Cosmetic treatment should not be injected in the presence of infection
at the proposed injection site(s) and in individuals with known
hypersensitivity to any ingredient in the formulation.
Serious heart problems and serious allergic reactions have been reported
rarely. If you think you’re having an
allergic reaction or other unusual symptoms, such as difficulty
swallowing, speaking or breathing, call your doctor immediately.
Individuals with peripheral motor neuropathic diseases (e.g.,
amyotrophic lateral sclerosis, or motor neuropathy) or neuromuscular
junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome)
should only receive BOTOX® or
BOTOX® Cosmetic with
caution. Patients with neuromuscular disorders may be at increased risk
of clinically significant systemic side effects with BOTOX® or BOTOX® Cosmetic.
For full prescribing information, please visit www.botox.com
and www.botoxcosmetic.com.
BOTOX® for
Blepharospasm in Patients = 12 Years of Age:
Reduced blinking from BOTOX® injection of the orbicularis muscle can lead to corneal exposure,
persistent epithelial defect and corneal perforation. The most
frequently reported treatment-related adverse reactions in these
patients are ptosis (20.8%), superficial punctate keratitis (6.3%) and
eye dryness (6.3%).
BOTOX® for
Strabismus in Patients = 12 Years of Age:
Inducing paralysis in one or more extraocular muscles may produce
spatial disorientation, double vision or past pointing. The most
commonly reported adverse effects are ptosis (16%) and vertical
deviation (17%).
BOTOX® for
Cervical Dystonia in Adults: There have been rare cases of dysphagia
severe enough to warrant the insertion of a gastric feeding tube. The
most frequently reported adverse reactions in patients with cervical
dystonia are dysphagia (19%), upper respiratory infection (12%), neck
pain (11%), and headache (11%).
BOTOX® for
Severe Primary Axillary Hyperhidrosis Inadequately Managed with Topical
Agents: The most frequently reported adverse events (3 - 10%) are
injection site pain and hemorrhage, non-axillary sweating, infection,
pharyngitis, flu syndrome, headache, fever, neck or back pain, pruritus,
and anxiety.
BOTOX® Cosmetic
for Temporary Improvement in the Appearance of Moderate to Severe Frown
Lines Between the Brows in Adults 18-65: The most common side
effects following injection include temporary eyelid droop and nausea.
Localized pain, infection, inflammation, tenderness, swelling, redness
and/or bleeding/bruising may be associated with the injection.
Forward-Looking Statements
This press release contains "forward-looking
statements,” including statements regarding
the safety, effectiveness and adverse events associated with BOTOX®.
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; inconsistency of treatment
results among patients; potential difficulties in manufacturing; 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 2006 Form 10-K and Allergan’s
Form 10-Q for the quarter ended September 28, 2007. Copies of Allergan’s
press releases and additional information about Allergan is available on
the World Wide Web at www.allergan.com
or you can contact the Allergan Investor Relations Department by calling
1-714-246-4636.
About Allergan, Inc.
Founded in 1950, Allergan, Inc., with headquarters in Irvine,
California, is a multi-specialty health care company that discovers,
develops and commercializes innovative pharmaceuticals, biologics and
medical devices that enable people to live life to its greatest
potential – to see more clearly, move more
freely, express themselves more fully. The Company employs more than
7,500 people worldwide and operates state-of-the-art R&D facilities and
world-class manufacturing plants. In addition to its
discovery-to-development research organization, Allergan has global
marketing and sales capabilities with a presence in more than 100
countries.
© 2008 Allergan,
Inc. Irvine, CA 92612. ®
and ™ marks owned by Allergan, Inc.
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