Abstract
Between 2015 and 2017, a marked increase of anaphylactic-like reactions after intravenous administration of gentamicin was observed first in horses and, later, also in humans. This worldwide issue led to safety measures including product recalls and safety warnings. Here, a German Marketing Authorization Holder (MAH) of an early and intensely affected veterinary product containing gentamicin describes the clinical approach of the company to analyze the root cause and identify the causative agent in the active pharmaceutical ingredient (API). The pharmacovigilance data of the MAH are presented, along with pharmacovigilance phenomena observed during the affected period. An overview is given on further investigations of the API manufacturer and measures taken by all parties involved, including competent authorities to reestablish a safe use of gentamicin products. The histamine contamination of gentamicin was an exceptional incident of global extent, affecting not only veterinary but also human drug safety. The reactions in horses transpired to also be an indicator of a human health threat, which ultimately contributed to an improvement in the safety of human and veterinary medicinal products containing fermentative APIs. The extreme dimensions of this issue emphasise the important role that veterinary clinicians and practitioners play in spontaneous reporting based pharmacovigilance systems and, by this, in drug safety.
Highlights
The aminoglycoside, gentamicin, is a widely used antibiotic in equine medicine
We present an example of such a rare incident from the point of view of the Marketing Authorization Holder of authorship, when between 2015 and 2017, a marked increase of adverse events was observed in horses after intravenous injection of gentamicin
As pharmaceutical investigations could not identify any scientific reason for the increase in adverse reactions, already after the recall in 2015, reporting veterinarians were requested by the Marketing Authorization Holder (MAH) to provide information, on other substances administered to the reacting horse over the same time period, and on treatments, especially vaccinations, within the previous 12 months
Summary
The aminoglycoside, gentamicin, is a widely used antibiotic in equine medicine. As with humans, the preferred administration route for systemic use in horses is via intravenous injection. As pharmaceutical investigations could not identify any scientific reason for the increase in adverse reactions, already after the recall in 2015, reporting veterinarians were requested by the MAH to provide information, on other substances administered to the reacting horse over the same time period, and on treatments, especially vaccinations, within the previous 12 months This was conducted to check for possible unknown interactions that might trigger the reactions; the evidence did not support this possibility. In inconspicuous batches this pronounced increase in number of reports of hypersensitivity-like adverse events was not observed and, for these, safety measures were not necessary In this context, it is important to understand that anaphylactic reactions can be expected in the usual safety profile of gentamicin solutions for injection. The information on this causative agent was shared with the API manufacturer, Competent Authorities and other concerned pharmaceutical companies
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