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Serious Adverse Effects Reported With Use of Botulinum Toxin Type A OTTAWA, Ontario -- January 13, 2009 -- Health Canada and Allergen is informing healthcare professionals about important safety information related to botulinum toxin type A (Botox and Botox Cosmetic) and the potential risk of serious adverse effects of muscle weakness remote to the site of injection, also referred to as possible distant spread of toxin. Over the last several months, Allergan has worked closely with Health Canada to update the product monographs for botulinum toxin type A to include additional safety information and provide additional guidance for the optimal use of this product. Key safety updates within the new product monographs for botulinum toxin type A include the following: · Patients may experience muscle weakness remote to the site of injection. Possible symptoms include muscle weakness, dysphagia, aspiration pneumonia, speech disorders, and respiratory depression. These reactions can be fatal. · Patients or caregivers should be advised to seek immediate medical care if swallowing, speech or respiratory disorders arise. · Botulinum toxin type A should only be given by physicians with the appropriate qualifications and experience in the use of botulinum toxin type A. The revised product monographs emphasise the need to follow the recommended dosage and frequency of administration. · Patients with a history of underlying neurological disorders, dysphagia and/or aspiration should be treated with extreme caution. The botulinum toxin product should be used under specialist supervision in these patients and should only be used if the benefit of treatment is considered to outweigh the risk. Muscle weakness remote to the site of injection and other serious adverse effects have been reported rarely for botulinum toxin type A in both paediatric and adult patients. Some cases had a fatal outcome. Recommendations on dosing guidelines and proper administration are listed for each approved indication. The newly updated product monographs are available on the Health Canada website, by performing a search of the Drug Product Database on Health Canada's website. Any case of serious suspected distant toxin spread or other serious or unexpected adverse reactions in patients receiving botulinum toxin type A should be reported to Allergan or Health Canada at the following addresses: Allergan Canada 85 Enterprise Blvd., Suite 500 Markham, Ontario L6G 0B5 Tel: 800-668-6424 or Fax: 905-940-190 Canada Vigilance Program Marketed Health Products Directorate HEALTH CANADA Address Locator: 0701C Ottawa, Ontario, K1A 0K9 Tel: 613-957-0337 or Fax: 613-957-0335 To report an Adverse Reaction, consumers and health professionals may call toll free: Tel: 1-866-234-2345 Fax: 1-866-678-6789 CanadaVigilance@hc-sc.gc.ca SOURCE: Health Canada E-mail this page to a friend or colleague! To print, use this version