Increase of Adverse Events After Intravenous Injection of Gentamicin in Horses Between 2015 and 2017-From Marketing Authorization Holder’s Point of View.

The research article explores the increase in harmful reactions in horses following the intravenous injection of the antibiotic gentamicin between 2015 and 2017. The reactions later mirrored in humans. The manufacturer’s analysis, response, and subsequent measures to ensure the safety of gentamicin use is discussed.

Background

• The paper begins with the observation of a sudden increase in anaphylactic-like reactions in horses upon being administered gentamicin intravenously between 2015 and 2017. This same reaction was later seen in humans, which raised worldwide concerns about the drug’s safety, resulting in product recalls and safety warnings.

Pharmacovigilance and Investigations

• A German Marketing Authorization Holder (MAH), the company responsible for the veterinary product containing gentamicin, undertook an investigation. They were driven to find the root cause of the anaphylactic reactions and identify the causative agent in the active pharmaceutical ingredient (API).
• The MAH presented pharmacovigilance data and observed phenomena during the affected period. Pharmacovigilance refers to the activities and interventions designed to identify, assess, understand and prevent adverse effects or any other drug-related problems.

Impact and Response

• The study reflects on the magnitude of the incident, stating it as exceptional with global implications. It affected not only the veterinary field but also human drug safety, pinpointing the histamine contamination in gentamicin as the culprit.
• The adverse reactions in horses eventually served as a warning sign for a potential human health threat. This consequently led to improvements in the safety of human and veterinary medicinal products containing fermentative APIs. The fermentative APIs are those produced using fermentors that enable the growth of organisms like bacteria and yeast.

Role of Veterinary Practitioners

• Lastly, the article underlines the crucial involvement of veterinary clinicians and practitioners in drug safety. It was through their observations and spontaneous reporting that the issue was identified and addressed. These reports thus contributed significantly to the pharmacovigilance systems, verifying the efficacy and safety of drugs not only in animals but also in humans.