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Botox Infection

Botox infections have become a concern among the consumer advocacy group Public Citizen because of cited cases of Botox infections among children and adults. The Food and Drug Administration has taken drastic measures to ensure the risks of Botox are adequately explained and available to patients before any Botox procedure is performed.

  1. What are Botox Infections?

    • Botox infections occur when the effects of Botox spread from the original infection site into other areas of the body. Possible Botox infections symptoms have been reported to be droopy eyelids, numbness, headaches, swallowing and breathing problems, respiratory failure, fluid in the lungs, pneumonia, difficulty speaking, muscle weakness, paralysis, botulism, birth defects and death in some cases.

    Black Box Warning

    • The FDA has mandated that manufacturers of licensed botulinum toxic products add the black box warning to their products, explaining to patients the risks they're taking when using Botox and the toxin's effects spread beyond the injection site. A black box warning is the strongest warning issued by the FDA. The FDA also requires that manufacturers develop and start implementing a Risk Evaluation and Mitigation Strategy to provide patients with more information on the risks involved when using the Botox toxin, along with a medication guide to alert patients to the risk of Botox infections, as well as submitting safety records.

    Statistics

    • According to Public Citizen, a consumer advocacy group, of the first 180 U.S. patients who reported suffering from symptoms of Botox infection, 16 died. The FDA has also reported several deaths in children treated with high doses of Botox.

    Risks and Chances

    • The chance of someone getting a Botox infection is less than 0.5 percent, and those infections can normally be treated with antibiotics. In severe cases, a patient may require drainage or surgery to stop the infection. The risks of general body symptoms of Botox infection is less than 0.1 percent and can include skin rashes, itchiness, flu-like symptoms, general malaise, fever, headaches and drowsiness that can last from a few hours up to several days.

    Off-label Uses

    • Botox has been used to help muscle spasms and headaches, and limb issues in cerebral palsy patients. The FDA has not approved Botox for treatment in limb spasticity in adults or children, but has approved Botox for a limited number of therapeutic conditions. The FDA is concerned about this off-label use causing Botox infections in patients.

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