Information Update - New Labelling Information for all Botulinum Toxin Products: Botox/Botox Cosmetic, Dysport, Xeomin/Xeomin Cosmetic and Myobloc
OTTAWA, Jan. 21, 2013, 2013 (Canada NewsWire via COMTEX) --
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
-- Manufacturers will have one year to comply with the labelling
-- Continue reporting any side-effects from the use of botulinum
toxin products to MedEffect: Call toll-free at 1-866-234-2345,
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
Dysport is indicated for the temporary improvement in the appearance of
moderate to severe wrinkles in adult patients less than 65 years of
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
To view this news release in HTML formatting, please use the following URL: http://www.newswire.ca/en/releases/archive/January2013/21/c7372.html
SOURCE: Health Canada
SOURCE: Government of Canada
Media Inquiries: Health Canada (613) 957-2983 Public Inquiries: (613) 957-2991 1-866
225-0709 Également disponible en francais
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