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Your Therapy Source, Inc
Your online resource for school based therapy and special
needs publications for professional, home and school use.
Your online resource for school based therapy and special
needs publications for professional, home and school use.
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FDA Report on Botox and Cerebral Palsy
On February 8, 2008 the Federal Drug Administration (FDA) issued a report on the use of
Botulinum Toxin Type A and Type B in children and adults. They have received reports of
severe adverse reactions (which may be botulism) to botulinum doses including
hospitalization and death in children. These adverse effects have occurred mostly in
children with spastic cerebral palsy. Doctors are currently using botox off label in children
with cerebral palsy for the drug is not approved for this use in the United States. The FDA is
presently reviewing: data from pharmaceutical companies, medical research and
evaluating cases from its reporting system. Currently the FDA reports that most of the
pediatric cases were children under 16 years old with cerebral palsy limb spasticity.
The FDA recommends that any professionals that work with clients who receive botulinum
should be aware of the symptoms of botulism. Some symptoms of botulism are difficulty
swallowing, weakness, difficulties breathing, voice changes and shortness of breath. They
should also inform the clients of these symptoms so that they are aware of potential side
effects and to seek immediate medical attention. In addition, the FDA reports that these
symptoms of botulism have been reported to occur as quickly as one day after botox and as
late as several weeks after the botox treatment.
The FDA plans to follow up on this report when the review of all the data is complete. If you
have had experience with serious side effects of botulinum, the FDA would like you to report
it by filling out a form at http://www.fda.gov/medwatch/report/hcp.htm.
Reference: US Food and Drug Administration. Early Communication about an Ongoing
Safety Review Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc
(Botulinum toxin Type B). Retrieved from the web on 3/19/08 at
http://www.fda.gov/cder/drug/early_comm/botulinium_toxins.htm.
On February 8, 2008 the Federal Drug Administration (FDA) issued a report on the use of
Botulinum Toxin Type A and Type B in children and adults. They have received reports of
severe adverse reactions (which may be botulism) to botulinum doses including
hospitalization and death in children. These adverse effects have occurred mostly in
children with spastic cerebral palsy. Doctors are currently using botox off label in children
with cerebral palsy for the drug is not approved for this use in the United States. The FDA is
presently reviewing: data from pharmaceutical companies, medical research and
evaluating cases from its reporting system. Currently the FDA reports that most of the
pediatric cases were children under 16 years old with cerebral palsy limb spasticity.
The FDA recommends that any professionals that work with clients who receive botulinum
should be aware of the symptoms of botulism. Some symptoms of botulism are difficulty
swallowing, weakness, difficulties breathing, voice changes and shortness of breath. They
should also inform the clients of these symptoms so that they are aware of potential side
effects and to seek immediate medical attention. In addition, the FDA reports that these
symptoms of botulism have been reported to occur as quickly as one day after botox and as
late as several weeks after the botox treatment.
The FDA plans to follow up on this report when the review of all the data is complete. If you
have had experience with serious side effects of botulinum, the FDA would like you to report
it by filling out a form at http://www.fda.gov/medwatch/report/hcp.htm.
Reference: US Food and Drug Administration. Early Communication about an Ongoing
Safety Review Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc
(Botulinum toxin Type B). Retrieved from the web on 3/19/08 at
http://www.fda.gov/cder/drug/early_comm/botulinium_toxins.htm.
Disclaimer: These pages are not intended to provide medical advice or physician/therapist instruction.
Information provided should not be used for diagnostic or training purposes. Consult a therapist or
physician regarding specific diagnoses or medical advice.
Information provided should not be used for diagnostic or training purposes. Consult a therapist or
physician regarding specific diagnoses or medical advice.