Botulinum Toxin Alert: New Labeling for Botox and Others

The FDA has recently released additions to the labeling requirements for all Botulinum Type A Products. These actions are a result of adverse events that have occurred in both approved and unapproved uses where the toxin has spread beyond the injection site causing symptoms of botulism (difficulty breathing, difficulty swallowing, muscular weakness, drooping eyelids, constipation, aspiration pneumonia, speech disorder, facial drooping, double vision, or respiratory depression). The postmarketing case reports of these adverse events occurred primarily in children being treated for muscle spasticity due to cerebral palsy, and in adults being treated for spasticity or cervical dystonia.
It is important to note that, according to the FDA, “Definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of Botox at the labeled dose... have NOT been identified."

The FDA also has informed the manufacturers that development of a Risk  Evaluation and Mitigation System is necessary. The System would include a Communication Plan to provide more information regarding the risk for distant spread of botulinum toxin effects after local injection, as well as information to explain that botulinum toxin products cannot be interchanged. The System also would include a Medication Guide that explains the risks to patients. Once it is developed, dermatologists will distribute the Medication Guide to patients at the time of injection.

The bottom line is that this is an administrative change, but it does not indicate that there is any new information or that there has been any change in the previously understood potential side effects of Botulinum A Toxin. It is likely that the release of these guidelines will hasten the approval of Reloxin, one of several new Botulinum A Toxins in the pipeline, and the one that is closest to release. The appearance of competitors to Botox will almost certainly bring lower prices to consumers.

Gerald N. Bock MD

California Skin & Laser Center

Stockton & Lodi, CA