While there are some questions that still need to be answered and concerns about off-label use and the need for proper training, the panel agreed this was safe and effective if used properly with appropriate training and appropriate precautions, said the panel chair, Dr. Lynn A. Drake of the department of dermatology, Massachusetts General Hospital, Boston.
DCA should not be used off label, a concern that could be at least partially addressed in the label, and “without appropriate training, this product could be misused and mishandled and cause damage,” she added. In addition, because of some “very novel” aspects to this treatment, postmarketing data are needed, addressing questions that include whether it causes scarring that could affect surgery and other interventions in the future, she said.
The FDA usually follows the recommendations of its advisory panels. None of the panel members had relevant disclosures.