In Europe and the United States, regulatory agencies responsible for monitoring drug safety have struggled to address the health concerns raised by the burgeoning market for minimally invasive cosmetic procedures utilizing botulinum toxins, the active ingredients in Botox. A 2005 study published in the Journal of the American Academy of Dermatology drew attention to these shortcomings after an analysis of adverse event reports submitted to the Food and Drug Administration (FDA) linked twenty-eight patient deaths to Botox-induced respiratory arrest and myocardial infarction. After an independent review of adverse effects reports submitted to the European Medicines Agency (EMEA) revealed similar findings in Europe, the FDA and EMEA implemented bolstered product warnings aimed at increasing patient awareness of the drug’s health risks. This Note compares the FDA and EMEA’s heightened warning protocols and argues that the agencies’ recent efforts are unlikely to reduce the number of serious adverse events linked to botulinum toxins.

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Taming the Perfect Poison: A Comparative Analysis of the EMEA's EPAR System and the FDA's Improved Warning Protocol