In late January, a consumer group called Public Citizen filed a petition with the FDA requesting labeling alterations for botulinum toxins (Botox(R)) or Myobloc(R)) marketed in the U.S. The American Society for Aesthetic Plastic Surgery (ASAPS), which is the sole plastic surgery organization devoted completely to the advancement of cosmetic surgery, said that “the safety references in the petition are already satisfactorily addressed in the manufacturer labeling with detailed information and guidance, including approved indications, contraindications, warnings, drug interactions, precautions, and reported adverse event information.”
The ASAPS added that the product is “safe and efficacious,” while recommending its continued use as indicated.