Abstract: Jacques Descotes MD, PharmD, PhD Professor Emeritus, Claude Bernard University of Lyon Fellow, US Academy of Toxicological Sciences Eurotox Registered Toxicologist IMMUNOSAFE CONSULTANCE 120 Chemin des Bouleaux 38480 Saint Jean d’Avelanne, France Tel. +33 (0)616 96 35 97 E-mail = descotes@me.com EXPERT REVIEW REPORT MEDICAL SAFETY OF IVERMECTIN As per the request of MedinCell SA (France), I the undersigned certify to have perused the publicly available information relevant to conduct an extensive analysis of ivermectin safety in human beings. The aim of the present review is to propose an independent, evaluative judgement of this information which includes original scientific publications and literature reviews, case reports, and any other source provided it can be undisputedly tracked down and freely accessed. The author personally collected and reviewed all the cited information from the beginning of September 2020 to the end of February 2021. Table of Contents I. II. III. IV. Executive summary ........................................................................................................ 2 Introduction ..................................................................................................................... 5 Summary of main nonclinical toxicity findings ................................................................ 9 Human adverse events and ivermectin exposure......................................................... 19 • Adverse events in clinical trials and following medical prescription of ivermectin .... 19 • Acute poisonings and accidental overdoses ............................................................ 24 V. Risk factors .................................................................................................................. 26 • Clinical safety of ivermectin in infants and children ................................................ 26 • Clinical safety of ivermectin in pregnant and breast-feeding women ...................... 26 • Clinical safety of ivermectin in the elderly ............................................................... 27 • Comorbidities ........................................................................................................... 27 • Drug associations .................................................................................................... 29 VI. Discussion ................................................................................................................... 31 VII. Conclusion .................................................................................................................... 33 VIII. References .................................................................................................................. 34 IX. Author's resume ........................................................................................................... 45 I. EXECUTIVE SUMMARY Ivermectin was first approved as a human medicine in 1987. In addition to 40 years of extensive use as a veterinary medicine, it has been prescribed to hundreds of millions of human beings worldwide to prevent or treat a variety of parasitic diseases. Recently, the anti-SARS-cov-2 activity of ivermectin became the focus of numerous experimental studies and clinical trials, the results and interpretation of which generated a vigorous and still ongoing debate to establish how effective ivermectin is or could be against COVID-19. Drug approvals by regulatory..