FDA Issues Botox Side Effects Warning
The Food and Drug Administration has warned that the popular drug Botox has been linked to dangerous botulism symptoms, which has resulted in an unspecified number of deaths. Botox is best known as an anti-wrinkle treatment, but the drug is also approved to treat select neurological conditions and excessive sweating. The drug is also commonly used off-label (non-approved used) for the treatment of muscle spasticity in cerebral palsy patients. In its warning, the FDA said it was aware of literature describing the use of Botox to treat limb spasticity in children and adults, but the safety, efficacy and dosage of the drug have not been established for the treatment of limb spasticity of cerebral palsy or for use in any condition in children less than 12 years of age.The FDA warning came in the form of an "Early Communication about an Ongoing Safety Review" which means the agency has just begun to investigate the safety concerns, and will most likely release more information to patients and doctors. The FDA said it was considering, but has not reached a conclusion about whether this information warrants any regulatory action.
The warning focused primarily on reports of systemic adverse reactions including respiratory failure and death following the use of Botox and its competitor Myobloc, for both approved and unapproved uses. These reactions appear to be the result of botulism, which occurs when botulinum toxin from Botox or Myobloc spreads in the body beyond the site where it was injected.
The most serious reports of adverse events mostly involved children being treated for cerebral palsy related muscle spasticity, which lead to hospitalization and death. It is important to note that the use of Botox or Myobloc for the treatment of muscle spasticity is not approved n the United States for adults or children.
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What are the risks?
Adverse reactions can include paralysis of the respiratory muscles and difficulty swallowing (dysphagia), a condition that can allow food or liquid to enter the respiratory tract and lungs, causing aspiration pneumonia.
The Public Citizen analysis of FDA data found that between Nov. 1, 1997, and Dec. 31, 2006, there were 658 reported cases of people suffering adverse effects from injections of botulinum toxin. Of these, 180 were associated with aspiration (fluid in the lungs), dysphagia and/or pneumonia; 87 required hospitalization.
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