Printer Friendly
The Free Library
14,538,027 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Allergan, Inc. Comments on BOTOX(R) (Botulinum Toxin Type A) Safety Profile.


IRVINE, Calif. -- Allergan, Inc. (NYSE NYSE

See: New York Stock Exchange
: AGN AGN Again (Amateur Radio)
AGN Active Galactic Nucleus
AGN Acute Glomerulonephritis
AGN Accountants Global Network
AGN Air Gabon (ICAO code) 
) today commented on a petition filed by Public Citizen yesterday with the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) 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([R]) and BOTOX([R]) Cosmetic (botulinum toxin type A botulinum toxin type A

Botox, Botox Cosmetic, Dysport (UK), Vistabel (UK)

Pharmacologic class: Neurotoxin

Therapeutic class: Neuromuscular blocker

Pregnancy risk category C

Action

) (collectively referred to in this press release as "BOTOX([R])").

There are no safety issues raised in the petition that are not already addressed in the labeling for BOTOX([R]). Allergan takes its FDA-mandated labeling obligations very seriously. The current label for BOTOX([R]) provided to physicians in the United States provides detailed information and appropriate guidance on the proper uses of BOTOX([R]), 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([R]) 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([R]) is a widely researched medicine. BOTOX([R]) 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 de·bil·i·tat·ing
adj.
Causing a loss of strength or energy.


Debilitating
Weakening, or reducing the strength of.

Mentioned in: Stress Reduction
 disorders, as well as to those with aesthetic needs.

For any medical inquiries related to the proper use of BOTOX([R]), please contact Allergan's Medical Information Department at 1-800-433-8871.

Important BOTOX([R]) and BOTOX([R]) Cosmetic (Botulinum Toxin Type A) Information

BOTOX([R]) 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([R]) is also indicated for the treatment of strabismus strabismus (strəbĭz`məs), inability of the eyes to focus together because of an imbalance in the muscles that control eye movement; also called squint.  and blepharospasm bleph·a·ro·spasm
n.
Spasmodic winking caused by the involuntary contraction of an eyelid muscle.



blepharospasm

spasm of the orbicularis oculi muscle of the eyelid.
 associated with dystonia dystonia /dys·to·nia/ (-to´ne-ah) dyskinetic movements due to disordered tonicity of muscle.dyston´ic

dystonia musculo´rum defor´mans
, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and above.

The efficacy of BOTOX([R]) treatment in deviations over 50 prism diopters, in restrictive strabismus, in Duane's syndrome with lateral rectus rectus /rec·tus/ (rek´tus) [L.] straight.

rectus

[L.] straight.


rectus abdominis muscle
see Table 13.2.

ocular rectus muscle
see Table 13.1F.
 weakness, and in secondary strabismus caused by prior surgical over-recession of the antagonist has not been established. BOTOX([R]) is ineffective in chronic paralytic paralytic /par·a·lyt·ic/ (par?ah-lit´ik)
1. affected with or pertaining to paralysis.

2. a person affected with paralysis.


par·a·lyt·ic
adj.
1.
 strabismus except when used in conjunction with surgical repair to reduce antagonist contracture contracture /con·trac·ture/ (-cher) abnormal shortening of muscle tissue, rendering the muscle highly resistant to passive stretching. .

And BOTOX([R]) is indicated for the treatment of severe primary axillary ax·il·lar·y
n.
Relating to the axilla.


Axillary
Located in or near the armpit.

Mentioned in: Mastectomy


axillary

of or pertaining to the armpit.
 hyperhidrosis that is inadequately managed with topical agents.

BOTOX([R]) Cosmetic is approved for the temporary treatment of moderate to severe frown lines between the brows in people ages 18-65.

Important BOTOX([R]) and BOTOX([R]) Cosmetic (Botulinum Toxin Type A) Safety Information

BOTOX([R])and BOTOX([R]) Cosmetic treatment should not be injected in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen.  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 amyotrophic lateral sclerosis (ALS) (ā'mīətrōf`ik, sklĭrō`sĭs) or motor neuron disease, , or motor neuropathy) or neuromuscular junctional disorders (e.g., myasthenia gravis myasthenia gravis (mīəsthē`nēə grä`vĭs), chronic disorder of the muscles characterized by weakness and a tendency to tire easily.  or Lambert-Eaton syndrome) should only receive BOTOX([R])or BOTOX([R])Cosmetic with caution. Patients with neuromuscular disorders may be at increased risk of clinically significant systemic side effects with BOTOX([R])or BOTOX([R])Cosmetic. For full prescribing information, please visit www.botox.com and www.botoxcosmetic.com.

BOTOX([R])for Blepharospasm in Patients [greater than or equal to] 12 Years of Age: Reduced blinking from BOTOX([R])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 Ptosis Definition

Ptosis is the term used for a drooping upper eyelid. Ptosis, also called blepharoptosis, can affect one or both eyes.
Description

The eyelids serve to protect and lubricate the outer eye.
 (20.8%), superficial punctate keratitis (6.3%) and eye dryness (6.3%).

BOTOX([R])for Strabismus in Patients [greater than or equal to] 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([R])for Cervical Dystonia in Adults: There have been rare cases of dysphagia dysphagia /dys·pha·gia/ (-fa´jah) difficulty in swallowing.

dys·pha·gia or dys·pha·gy
n.
Difficulty in swallowing or inability to swallow.
 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 Noun 1. upper respiratory infection - infection of the upper respiratory tract
respiratory infection, respiratory tract infection - any infection of the respiratory tract
 (12%), neck pain (11%), and headache (11%).

BOTOX([R])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 pharyngitis

Inflammation and infection (usually bacterial or viral) of the pharynx. Symptoms include pain (sore throat, worse on swallowing), redness, swollen lymph nodes, and fever.
, flu syndrome, headache, fever, neck or back pain, pruritus pruritus /pru·ri·tus/ (proo-ri´tus) itching.prurit´ic

pruritus a´ni  intense chronic itching in the anal region.

pruritus hiema´lis  xerotic eczema.
, and anxiety.

BOTOX([R])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([R]).

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.

((c)) 2008 Allergan, Inc. Irvine, CA 92612. ([R]) and [TM] marks owned by Allergan, Inc.
COPYRIGHT 2008 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2008, Gale Group. All rights reserved.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Date:Jan 25, 2008
Words:1242
Previous Article:Los Angeles Welcomes the 21st Century Hospital.
Next Article:Vistage International Names New Dallas Chair.
Topics:



Related Articles
Allergan gets green light after pre-license probe.(botulinum toxin Type A)(Brief Article)
Botox needs a make over. (Hot Flashes).(Brief Article)
Solstice looks for shot in competitive Botox market: S.D. company is pushing Myobloc as a reasonable alternative.(Biotech)(Solstice Neurosciences Inc)
Effectiveness of repeated treatment with botulinum toxin type A across different conditions.
Allergan adds a new wrinkle to anti-aging market.(As We Go To Press)
Use of botulinum toxin type A in children with cerebral palsy.(Update)
Traveling toxin: Botox may hitch a ride on nerve cells.(This Week)
FDA says Botox linked to children's deaths.(Recalls/warnings)(food and drug administration)
Allergan gets subpoena on Botox promotion.(Litigation)
Fears grow over Botox safety.(Drug Safety)(Brief article)

Terms of use | Copyright © 2009 Farlex, Inc. | Feedback | For webmasters | Submit articles