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Botox and Similar Botulinum Products to Get Black Box Warning

The FDA announced yesterday that all botulinum toxin products will now require a black box warning for safety purposes. The agency decided to require a stronger warning due to interchangeability problems among the 3 main botulinum drugs and serious adverse events that were being reported. Many of the adverse events reported concerned that the botulinum toxin could spread from the injection site to other areas of the body, causing symptoms similar to those of botulism. Some of these symptoms include: unexpected loss of strength or muscle weakness, trouble talking and saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double/blurred vision, and droopy eyelids. Most of these symptoms have been reported in children that take botulinum drugs for cerebral palsy, but some symptoms have been reported by adults that use botulinum for both FDA approved and unapproved uses.

The products that the FDA is requiring to adopt a new label are:

  • Botox and Botox Cosmetic
  • Myobloc
  • Dysport

All three drugs are FDA approved to treat cervical dystonia, a condition where the muscles in the neck constantly contract. Botox Cosmetic and Dysport are used to temporarily treat “frown lines” between the eyebrows. Also Botox is used for severe underarm sweating, crossed eyes, and abnormal tics of the face. Treatment of muscle spasticity for cerebral palsy is not an FDA approved use of any of the three botulinum drugs.

The FDA wants healthcare professionals to understand that that dosage strength is not interchangeable between the three drugs. A dose in one of the botulinum drugs may be more potent than a dose of another botulinum drug. Also, adverse events have been reported as little as a few hours after the drugs were administered to as long as several weeks after the drugs have been administered.

Anyone who has experienced adverse experiences from the use of the drug should report it to the FDA.

For more information, see the FDA warning page:

See also the FDA’s response to the Citizen Petition at:

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