Botox and Cerebral Palsy

FDA Findings for this Unapproved Use of Botox

© ShawnTe Pierce

May 15, 2009
Cosmetic grade botulinum or Botox A has been used to treat children with cerebral palsy since the 1990s. However, this use of Botox is not FDA approved.

Botox Treatment for Cerebral Palsy

Since the 1990s a form of botulinum commonly known as Botox A, has been used as a treatment for cerebral palsy in children. Doctors maintain that Botox injections ease the overactive muscles in children suffering from cerebral palsy. Botox is injected into atrophied muscles and joints to relax them and improve range of motion. A typical treatment lasts between three to six months. During this time physical therapy allows for the patient to become accustomed to using the inactive limb(s). Data shows that over time, mobility and strength are restored to the affected limb(s).

Patients undergoing Botox treatment have seen a decrease for the need of other medications to treat their cerebral palsy. Also painful surgical procedures are reduced as a result of the Botox treatments. While Botox is a temporary treatment for cerebral palsy, patients are seeing long term benefits. Botox treatment is being viewed as a medical breakthrough for the treatment of cerebral palsy.

FDA Issues Arise

However, despite the success stories concerning the benefits of using Botox A for treating cerebral palsy, its use for this treatment is not approved by the Food and Drug Administration (FDA). Many children receiving such treatment for cerebral palsy are those under 12 years of age. The FDA has not approved the use of any form of botulinum toxin to be administered to children under the age of 12. The FDA cannot approve its use yet until the administration itself has tested its efficacy and safety for persons less than 12 years of age. Moreover, the use of Botox to treat spasticity issues is not FDA approved in the US for adults or children.

Botulism Cases Reported

Over the past two years or so, the FDA has received reports about cases of botulism occurring in people undergoing procedures using different forms of the botulinum toxin. According to the Centers for Disease Control and Prevention (CDC) botulism is a nerve toxin that leads to paralysis, more often causing respiratory problems to the degree that the infected person will need a ventilator to aid them with breathing. Fortunately, thanks to modern medical science, botulism deaths are rare. However, while not a contagious disease, botulism is a serious health concern.

Cases reported have ranged from mild to severe with respiratory failure and even death. All serious FDA reported cases have occurred in children. February 8, 2008, the FDA released a report advising the public of its investigation into these cases. This report outlines the FDA’s stance on the use of Botox and other forms of the botulinum toxin, an overview on the cases that have been reported to them both fatal and non-fatal, and guidelines for medical professionals on what to look for and how to advise patients of possible side effects.

Some of the botulism symptoms reported include:

  • Dysphagia – the inability to swallow or having difficulty swallowing
  • Respiratory deficiency that required the use of a feeding tube and ventilator support
  • Ptosis – drooping eyelid
  • And difficulty holding up one’s head

The FDA is still continuing with their investigation into these cases of botulism. The FDA is making it known to the medical industry what treatments Botox is approved and not approved for. In addition, the medical industry has been made aware of the doses of each form of Botox that may cause botulism to affect patients. Ask your health care professional about the FDA’s findings and the potential risks and side affects associated with using Botox to treat your child’s cerebral palsy.

Resources

Early Communication about an Ongoing Safety Review: Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B)

Battling Cerebral Palsy with Botox

Centers for Disease Control and Prevention


The copyright of the article Botox and Cerebral Palsy in Physical Disabilities is owned by ShawnTe Pierce. Permission to republish Botox and Cerebral Palsy in print or online must be granted by the author in writing.




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Comments
Jun 21, 2009 10:55 PM
Guest :
Thank you very much for your article.

Upali from SriLanka.
1 Comment: