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Concerns Over Botox Safety

The FDA has issued a statement notifying the public about systemic adverse reactions caused by Botox, Botox Cosmetic (botulinum toxin type A) and Myobloc (botulinum toxin type B). Systemic adverse reactions have been linked to a variety of treatments, both approved and unapproved by the FDA, and a wide range of doses. Reported incidents had presentation similar to botulism, in which botulinum toxin spreads throughout the body.

The most serious cases included respiratory failure and death in children treated for cerebral palsy-associated limb spasticity. FDA has reiterated that the use of botulinum toxin for limb spasticity is not currently approved in the U.S. Safety and efficacy of botulinum toxin treatment in children with limb spasticity of cerebral palsy or for any condition in children under 12 years of age has not been established. The agency is now reviewing clinical trial safety data submitted by the drug’s manufacturers.

• Botox (botulinum toxin A) is currently approved for blepharospasm (eyelid spasm), cervical dystonia (neck muscle spasm), and primary axillary hyperhydrosis (excessive sweating).
• Botox Cosmetic (also botulinum toxin type A) is approved for temporary improvement of moderate to severe facial frown lines.
• Myobloc (botulinum toxin type B) is approved for treatment of cervical dystonia in adults.

Until the FDA completes its review, healthcare professionals using botulinum toxin should:

• Understand that potency determinations expressed in “Units” or “U” are different among the botulinum toxin products; clinical doses expressed in units are not comparable from one botulinum product to the next
• Be alert to the potential for systemic effects following administration of botulinum toxins such as: dysphagia, dysphonia, weakness, dyspnea or respiratory distress
• Understand that these effects have been reported as early as one day and as late as several weeks after treatment
• Provide patients and caregivers with the information they need to be able to identify the signs and symptoms of systemic effects after receiving an injection of a botulinum toxin
• Tell patients they should receive immediate medical attention if they have worsening or unexpected difficulty swallowing or talking, trouble breathing, or muscle weakness

Should the public be concerned about this statement issued by the FDA, or should those interested in using Botox for any condition, disregard it and wait until the FDA finishes its safety review of the medication?

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