Allergan Comments on Today's Follow up by the U.S. Food and Drug Administration (FDA) to Its Early Communication, Concluding the Agency's Safety Review of Botulinum Toxins.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 provided a further clarification on the U.S. Food and Drug Administration's (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. ) conclusion to its "Early Communication" regarding a safety review of botulinum toxins in the United States. On February 8, 2008, the FDA announced in an "Early Communication" that it was reviewing certain serious adverse events following the use of botulinum toxins. At the time, the FDA hosted a public teleconference, explaining that the review involved only a "relative handful of serious adverse events" and that the primary focus of the adverse events and the FDA's review of them related to the therapeutic use of BOTOX([R]) to treat juvenile cerebral palsy and other large muscle, lower limb spasticities, particularly at higher doses in neurologically compromised patients. Both before and after the Early Communication on February 8, 2008, Allergan provided adverse event reporting information and analyses from its safety database to the FDA. Yesterday and today, the FDA took three actions: [TABLE OMITTED] In its update to the early communication and press conference, the FDA explained the results of its analysis and its conclusion that there have been infrequent reports of serious adverse events associated with potential spread of product from the site of injection and that the risk is greatest in children treated for juvenile cerebral palsy but also in adults treated for spasticity or cervical dystonia who have underlying conditions that would predispose them to these symptoms. The proposed boxed warning provides similar context. Dr. Ellis Unger, M.D., Deputy Director (Acting) of the FDA's Office of Drug Evaluation, answered questions and clarified the following in the press conference: [TABLE OMITTED] Finally, to provide additional context, it is important to understand that while bulk botulinum toxin is a potent biological agent, BOTOX([R]) is not bulk botulinum toxin. Instead, it is a finished medical product and a vial of BOTOX([R])contains an extraordinarily minute amount (only four billionths of a gram) of botulinum toxin. BOTOX([R]) does not contain clostridium botulinum spores and does not cause botulism botulism (bŏch`əlĭz'əm), acute poisoning resulting from ingestion of food containing toxins produced by the bacillus Clostridium botulinum. at labeled doses. Allergan will work with the FDA to appropriately update the label for BOTOX([R]) and BOTOX([R])Cosmetic in light of the FDA's conclusions. In the interim, caution should be exercised if treating neurologically vulnerable patients with high doses of BOTOX([R]). Allergan would also like to emphasize the following precautions: * No other botulinum toxin is interchangeable with BOTOX([R])or BOTOX([R]) Cosmetic and caution should be exercised when substituting another botulinum toxin for BOTOX([R])or BOTOX([R]) Cosmetic. * Patients should seek immediate medical attention if they develop the following symptoms: unexpected loss of strength or muscle weakness, hoarseness or trouble talking (dysphonia dysphonia /dys·pho·nia/ (-fo´ne-ah) a voice impairment or speech disorder.dysphon´ic dys·pho·ni·a n. Difficulty in speaking, usually evidenced by hoarseness. ), trouble saying words clearly (dysarthria dysarthria /dys·ar·thria/ (dis-ahr´thre-ah) a speech disorder caused by disturbances of muscular control because of damage to the central or peripheral nervous system. dys·ar·thri·a n. ), loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids. Important 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) InformationBOTOX([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 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 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 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 2008 Form 10-K. 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 approximately 8,000 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. |
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