After receiving reports linking Botox, Botox Cosmetic and Myobloc to droopy eyelids, numbness, headaches, and swallowing and breathing problems, the U.S. Food and Drug Administration (“FDA”) mandated that manufacturers of licensed botulinum toxin products add a Black Box Warning regarding the risk of Botox infection.  Botox infection occurs when the effects of the toxin spread beyond the injection site.  In addition to the Black Box Warning, the FDA is requiring Botox manufacturers to develop and implement a Risk Evaluation and Mitigation Strategy (“REMS”) to provide more information on how botulinum toxin products can lead to Botox infection.  Furthermore, the FDA is also requiring drug makers to distribute a Medication Guide alerting patients of the potential risk of Botox infection, and to submit safety records.

Off-Label Use of Botox to Treat Cerebral Palsy Patients

Botulinum toxin, the active ingredient in Botox, Botox Cosmetic

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Dangerous Product Alerts

and — Myobloc, blocks nerve impulses to muscles.  The FDA has only approved the use of botulinum toxin for a limited number of therapeutic conditions.  It has not been approved for the treatment of limb spasticity in children or adults, nor has it been approved to treat any condition in children less than 12 years of age.  However, an investigation initiated by the FDA in February 2008 revealed that Botox injections have been used to treat limb spasticity (severe arm and leg muscle spasms) in cerebral palsy patients.  The FDA is concerned that this off-label use of Botox is causing Botox infections in patients.  The FDA has also reported several deaths in children due to Botox infections after the children received high doses of Botox. 

Symptoms of Botox Infection

The reported signs and symptoms of a potential Botox infection include:

  • droopy eyelids
  • numbness
  • headaches
  • swallowing and breathing problems
  • respiratory failure
  • fluid in the lungs
  • pneumonia
  • trouble talking
  • muscle weakness
  • paralysis
  • botulism
  • death

Botulinum Toxin Products Linked to Botox Infection

The Botox FDA Warning is a Black Box warning, which is the FDA’s strongest type.  In January 2008, the consumer advocacy group, Public Citizen, petitioned the FDA to add a Botox FDA Warning on the products’ labels because of the serious risks associated with Botox infection, and cited 180 cases of U.S. patients suffering fluid in the lungs, difficulty swallowing or pneumonia, including 16 deaths. 

Contact a Botox Infection Lawyer Today

If you or a loved one suffered injuries caused by a Botox injection, contact us today for a confidential and free case evaluation to see if you qualify for a Botox lawsuit.