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News: Bloorview responds to Health Canada report on Botox®

Health Canada issued a press release on January 13, 2009 informing Canadians and health care professionals that the labeling information of BOTOX ® and BOTOX Cosmetic ® will now include the risk of the toxin spreading to other distant parts of the body.

The announcement is a follow up to the information published in the October 2008 issue of Canadian Adverse Reactions Newsletter and does not contain any new information.

The issue reported 13 adverse reactions suggestive of distant toxin spread associated with Botox®. The reactions were reported over a 14-year period between 1994 and March 28, 2008.

Bloorview Kids Rehab was concerned to hear about this report, especially the five deaths reported, including two children with severe cerebral palsy. One child was being treated for muscle spasms and the other for drooling.

None of the deaths were medically confirmed as distant toxin spread, but Health Canada says the reactions may suggest the botulinum toxin had spread to parts of the body beyond where it was injected. As a result of this review, the product label has been updated to include guidelines and warnings:

• about rare reports of muscle weakness remote to the site of injection, including dysphagia and aspiration pneumonia, in children with severe cerebral palsy
• dosing information for treating patients for the on-label use of dynamic equinus (toe pointing).
• and the need for extreme caution in treating children with a history of aspiration pneumonia.

Bloorview takes a conservative and cautious approach to its use of Botox® in treating children with muscle spasticity related to cerebral palsy. Over 400 children each year safely receive Botox® injections in our spasticity clinics and we have not had any reports of serious side effects.

As a result of this new information, Bloorview has formalized its practice of not treating children who have pre-existing aspiration pneumonia and swallowing problems. In the rare situation where such a child could benefit from Botox®, the case will be reviewed by a physician panel before proceeding.

In some cases, Bloorview physicians recommend a higher dose to treat a child for muscle spasticity. In these cases, the recommended doses have been calculated based on the best available scientific information, and the number of muscles being injected.

Dr. Darcy Fehlings – who runs Bloorview’s spasticity clinics with Dr. Anne Kawamura – is world-renowned for her work and research on Botox®.

Dr. Fehlings is currently part of a group of experts co-authoring a review for the American Academy of Neurology that looks at the evidence to support the use of botulinum toxin in treating spasticity in the upper and lower limbs of children with cerebral palsy.

Based on Dr. Fehlings’ review and a meeting of researchers at the International Cerebral Palsy Conference in Australia in February 2009, Bloorview will assess whether any further changes are needed to its clinical practice guidelines for treating spasticity in children with cerebral palsy.

Bloorview will continue to offer Botox® treatments to clients and we will continue to discuss the benefits and risks of Botox® with families, so that they can make an informed decision about this treatment.

Please see Bloorview’s earlier response to a report from the Food and Drug Administration in the U.S. about its ongoing review into the safety of botulinum toxin.

For more information, please speak to your physician directly, or go to Health Canada.

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