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News: Bloorview responds to FDA report on Botox®

On Friday, February 8, 2008, the U.S. Food and Drug Administration (FDA) put out an early communication about its ongoing safety review of the use of Botulinum toxin (PDF). The FDA review indicated that it has found that Botox® (Botulinum toxin Type A) and Type B (not currently available in Canada) have been linked to adverse reactions, including respiratory failure and death in a “relative handful” of cases of children being treated for spasticity in their limbs associated with cerebral palsy.

Bloorview Kids Rehab was concerned to hear this report, and we have contacted Health Canada, which has confirmed that there have been no deaths related to the use of Botox® in Canada.

Bloorview has been using Botox® and therapy to treat spasticity in children with cerebral palsy and acquired brain injury for many years.  Over 400 children each year safely receive Botox® injections in Bloorview’s Spasticity clinics, and we have not had any reports of serious side effects (for example, difficulty breathing or swallowing, referred to as generalized weakness) following the injections. In Bloorview’s experience, and as reported in the scientific literature, the use of Botox® with children with cerebral palsy has a good safety record.

The FDA is not advising health-care professionals to discontinue prescribing (or using) these products, but to be aware of these new findings, and to speak with their clients about the possible risks of using Botox®.

Botox® is used in children with cerebral palsy and acquired brain injury who have spasticity (abnormal tone, spasm), to help relax the muscles. We use Botox® to treat spasticity with the intention of increasing the child’s mobility, relieving pain and maximizing comfort for the child, easing care giving, and facilitating muscle growth, which may prevent the need for orthopedic surgery in some children.

"That gives children the potential to develop better control of their movements and to carry that over into everyday activities,” Dr. Fehlings says.

Bloorview’s clinics are currently run by Dr. Darcy Fehlings and Dr. Anne Kawamura. Dr. Fehlings, a developmental pediatrician and scientist at Bloorview, is world-renowned for her work and research on Botox®.

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.

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