Counterfeit botulinum toxins—A serious risk to patient safety

Abstract

With the increasing use of botulinum toxin for a range of clinical and aesthetic conditions, particular attention has to be paid to the quality of products used for patient treatment. At all times, patients must be treated with products of the highest quality to avoid any issues about adverse reactions and safety-related, unwanted outcomes. In turn, increased botulinum toxin use has led to a similar increase in the number of counterfeit products arriving on the market. These counterfeits may become the subject of police and regulatory actions. We report studies on several counterfeit toxins that have appeared in Brazil, Italy, Iran and Russia and which claim to be Dysport® or Dysport®-like. In the majority of cases, the labelled potency of the counterfeit (as determined by an ELISA, endopeptidase assay or a mouse potency assay) was incorrect. For other counterfeits, only physical appearance has been examined due to the poor quality of the sample obtained. Although some counterfeits can look very similar to the licensed product in appearance, the contents of the vials, both active toxin and excipients, are highly questionable. The use of licensed toxin products from known suppliers is the main safeguard to ensure that patient safety is not jeopardised.