Allergan's Statement Regarding Treatment With BOTOX Cosmetic.Business Editors & Health/Medical Writers IRVINE, Calif.--(BW HealthWire)--May 16, 2002 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) ) recently announced the approval of 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) for temporary improvement in the appearance of moderate to severe glabellar lines (brow furrow furrow /fur·row/ (fur´o) a groove or sulcus.atrioventricular furrow the transverse groove marking off the atria of the heart from the ventricles. ) in adult men and women 65 or younger by 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. ). Since its approval, there has been a tremendous amount of press regarding the use of BOTOX(R) Cosmetic, which may have led to confusion regarding Allergan's marketing and promotion of BOTOX(R) Cosmetic. Allergan will responsibly and ethically market and promote BOTOX(R) Cosmetic. Allergan's position on the medical promotion of this brand includes the following: 1. BOTOX(R) Cosmetic should only be administered by or under the direction of a licensed and authorized health care professional who is trained and qualified to use BOTOX(R) Cosmetic. 2. BOTOX(R) Cosmetic should be administered in a medically appropriate environment as deemed suitable by the authorized health care professional. 3. Optimal results with BOTOX(R) Cosmetic are best assured when treatment is administered by well-trained and authorized professionals with an in-depth knowledge of the muscles that control facial expression facial expression, n the use of the facial muscles to communicate or to convey mood. , an understanding of the dynamics of aging, and the qualifications to determine the best aesthetic treatment option for each individual within a professional setting. 4. For these reasons, Allergan will responsibly market BOTOX(R) Cosmetic to aesthetic specialty physicians. These specialty physicians include dermatologists, plastic surgeons, facial plastic surgeons, oculoplastic surgeons, ophthalmologists and maxilofacial surgeons. Allergan's long-term focus is to ensure that BOTOX(R) Cosmetic continues to deliver the aesthetic results our patients expect. Allergan will support the training of aesthetic specialty physicians to inject BOTOX(R) Cosmetic through a program entitled BOTOX(R) Cosmetic Physicians' Network. Only physicians can register for this training. Although some physicians may decide to employ supervised and authorized non-physician medical personnel to administer BOTOX(R) Cosmetic, Allergan encourages physicians to satisfy consumer desires by personally assessing and treating their facial aesthetic patients. Side effects Side effects Effects of a proposed project on other parts of the firm. most often reported during clinical trials of BOTOX(R) Cosmetic included headache, respiratory infection, temporary eyelid eyelid /eye·lid/ (-lid) either of two movable folds (upper and lower) protecting the anterior surface of the eyeball. eye·lid or eye-lid n. droop, nausea and flu syndrome. Less frequently occurring adverse reactions adverse reactions, n.pl unfavorable reactions resulting from administration of a local anesthetic; responsible factors include the drug used, concentration, and route of administration. included pain in the face, erythema erythema (ĕr'əthē`mə), more or less diffuse redness of the skin due to concentration of an abnormally large amount of blood within the small vessels of the skin (hyperemia), as in burns. (redness) at the injection site and muscle weakness. These events are thought to be associated with the injection and occurred within the first week. BOTOX(R) Cosmetic should not be used in the presence of infection at the proposed injection site(s). Allergan's BOTOX(R) product is the only one of its type with over 10 years of successful clinical experience in therapeutic conditions. Full prescribing information for BOTOX(R) Cosmetic is available at www.botoxcosmetic.net. About Allergan, Inc. Allergan, Inc., with headquarters in Irvine, California, is a technology-driven, global health care company providing eye care and specialty pharmaceutical products worldwide. Allergan develops and commercializes products in the ophthalmic, neurological and dermatological markets that deliver value to our customers, satisfy unmet medical needs, and improve patients' lives. |
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