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Cerebral Palsy Botox treatments have new warnings

-Examiner

05/14/2009 - The Food & Drug Administration has released a new warning for the off-label use of Botox in spastic pediatric Cerebral Palsy patients. This is an update to the 2008 Early Communication regarding the drug. This new information will be added to the product label and patient information for future production of Botox A & B.

Botox was never approved for use in pediatric patients. Nor was it approved for use in the doses that are required to affect spastic muscles. However, it is a widely accepted treatment and administered to children with Cerebral Palsy thorough orthopedic clinics all over the country. Clinical trials have been done are under way at Seattle Children's Hospital.

The FDA states:

Botulinum toxin products have been approved by FDA for one or more of the following uses: temporary improvement in the appearance of glabellar lines (frown lines between the eyebrows), treatment of strabismus (crossed eyes), blepharospasm (abnormal tics and twitches of the eyelids), cervical dystonia (involuntary sustained or repetitive contraction of the neck muscles), and primary axillary hyperhidrosis (severe underarm sweating). For these uses, botulinum toxin is injected into the skin or into muscle tissue.

The new research has shown that the large amount of botulinum toxin injected into the deep muscle tissue spreads well beyond the spastic muscles. It has drastic side effects according to the FDA:

In pediatric postmarketing adverse event case reports, botulinum toxin products were mostly used to treat muscle spasticity in cerebral palsy, a use that has not been approved by the FDA. The reported cases of spread of botulinum toxin effect beyond the site of injection were described as botulism, or involved symptoms including difficulty breathing, difficulty swallowing, muscular weakness, drooping eyelids, constipation, aspiration pneumonia, speech disorder, facial drooping, double vision, or respiratory depression. Serious case reports described hospitalizations involving ventilatory support and reports of death.

If you suspect your child has any of these side effects, even up to three weeks post-injection, contact your local emergency facility immediately. The FDA also requests that all side effects be reported through MedWatch. Every report helps the next child.

If you or a loved one have been injured or suffered a loss due to Botox Side Effects you may be entitled to compensation. Contact the Botox Lawyers of Ennis & Ennis, P.A. today for a free Botox case evaluation by filling out the form on this page or calling toll-free: 1-800-856-6405.

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