Botox, Cerebral Palsy and Chiropractic
Posted by drtim on February 9, 2008
The FDA has just released the following notice on adverse reactions to Botox injections for approved and not approved uses of the drug, specifically spastic contracture of muscles in children. The media is reporting this dangerous off-label use of Botox as a treatment for conditions relating to cerebral palsy.
As you’ll read in the text of the FDA release, the problems occur away from the injection site, causing difficulty in swallowing, weakness and breathing problems. All are neurological symptoms of botulism poisoning.
Most chiropractors know that specific adjustments of the upper cervical spine may improve parasympathetic nervous system function. While the damage resulting from cerebral palsy may not be reversible, its effects can be reduced without subject children to off-label experimentation with dangerous drugs.
I know parents will go to any means to reduce their child’s suffering. But, medical quackery should not be allowed at the risk of a child already damaged at birth. If you or someone you know needs a referral to chiropractor in your area or if I can answer any specific questions, e-mail me today. Read “Rockie’s Story” on this blog or “Why I am a chiropractor” on my web site.
The full text and the link to the FDA’s notice follows:
Adverse Reactions Linked to Botox
Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) have been linked in some cases to adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses.
In an early communication based on FDA’s ongoing safety review, the agency said the reactions may be related to overdosing. There is no evidence that these reactions are related to any defect in the products.
The adverse effects were found in FDA-approved and nonapproved usages. The most severe adverse effects were found in children treated for spasticity in their limbs associated with cerebral palsy. Treatment of spasticity is not an FDA-approved use of botulism toxins in children or adults.
The adverse reactions appear to be related to the spread of the toxin to areas distant from the site of injection, and mimic symptoms of botulism, which may include difficulty swallowing, weakness and breathing problems.
FDA is not advising health care professionals to discontinue prescribing these products. The agency is reviewing safety data from clinical studies submitted by the drugs’ manufacturers, as well as post-marketing adverse event reports and medical literature. After completing a review of the data, FDA will inform the public of its conclusions, resulting recommendations, and any regulatory actions.
