Health Law

Botox Warning Issued for Treating CP Symptoms in Children

Food and Drug Administration officials are warning about potentially fatal side effects associated with the use of Botox for treating muscle spasticity, particularly in children with this cerebral palsy symptom. Children with spastic cerebral palsy are sometimes treated with Botox, though the drug is not approved in the U.S. for this use.

The FDA said in a statement that some children given Botox for muscle spasticity have experienced symptoms of botulism. In some cases the symptoms have led to hospitalization and even death, according to the FDA.

Botulism symptoms may occur when the toxin spreads from the site of injection and include:

• Loss of muscle strength
• Difficulty speaking or hoarseness
• Vision problems
• Trouble breathing or swallowing
• Loss of bladder control

The agency is now requiring a bold black box warning on the labels of Botox and related botulinum toxin products. Parents of children with cerebral palsy who have questions or concerns about the risks associated with Botox should discuss this new warning with their physicians.



 

Full post as published by Cerebral Palsy Law Blog on May 02, 2009 (boomark / email).