Information Update - New Labelling Information for all Botulinum Toxin Products: Botox/Botox Cosmetic, Dysport, Xeomin/Xeomin Cosmetic and Myobloc

OTTAWA, Jan. 21, 2013 /CNW/ - In order to help prevent medication errors with the use of botulinum toxin products currently available on the Canadian market, Health Canada will be requesting that all manufacturers of these products revise their product labels to reflect that each product has its own individual potency and as such, is not interchangeable with other botulinum products.

The labelling changes are due to a risk evaluation of the active ingredients (Clostridium botulinum toxin type A and type B) within these products. Botulinum toxins are produced by different manufacturing processes, are obtained by different techniques and are derived from different Clostridium strains. As a result of these differences, these products cannot be interchanged as these changes can cause unexpected side-effects.

Advice to health care practitioners:

  • The established drug names of the botulinum products have not been changed yet to emphasize the differing dose-to-potency ratios of these products.
  • The following products will be impacted by labelling changes (see below).
  • Manufacturers will have one year to comply with the labelling change requests.
  • Continue reporting any side-effects from the use of botulinum toxin products to MedEffect: Call toll-free at 1-866-234-2345, visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Proprietary Name New Non-Proprietary Name
Botox / Botox Cosmetic OnabotulinumtoxinA
Xeomin / Xeomin Cosmetic IncobotulinumtoxinA
Dysport AbobotulinumtoxinA
Myobloc RimabotulinumtoxinB

Advice to Canadians:

  • All botulinum toxin products have usage information in the consumer section of the Product Monograph. Review it carefully with your health care practitioner.
  • Discuss any concerns you may have about the risks and benefits of botulinum products with your health care practitioner.
  • Pay close attention for any signs or symptoms of adverse events and seek immediate medical attention if you have unexpected difficulty swallowing or talking, trouble breathing, or muscle weakness following treatment with a botulinum toxin product.

Botox is indicated for the treatment of severe muscle spasm in the neck, eye and foot, for chronic migraines, incontinence, and for excessive sweating. Botox Cosmetic is indicated for cosmetic purposes, to treat facial wrinkling.

Dysport is indicated for the temporary improvement in the appearance of moderate to severe wrinkles in adult patients less than 65 years of age.

Xeomin is indicated for severe muscle spasm in the neck, eye and arm. Xeomin Cosmetic is indicated for the temporary improvement of moderate to severe frown lines in adult patients.

Myobloc is indicated for the treatment of adult patients with severe muscle spasm in the neck.

SOURCE Health Canada



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