Problem Or Issue:
Adverse reactions to the use of certain injectable gentamicin productsin horses have been reported in a number of European countries.
The products concerned are NOT authorised in Ireland and no adverse reactions have been reported to gentamicin injectable products for horses in Ireland to date. Nevertheless the HPRA urges caution when administering gentamicin to horses.
In the UK, between 1 October 2016 and 8 December 2016, there have been a number of reports of suspected adverse reactions involving 32 horses following the use of an injectable gentamicin formulation. The reports involve anaphylactoid signs including increased respiratory rate, sweating, weakness, recumbancy, shaking and colic. In most cases, the signs were reported to occur immediately following intravenous administration of the product concerned and resolved completely within 5-10 minutes. In two of the cases, death of the horse was reported, however other factors might have played a role in these deaths. A recall of one batch of the UK authorised product has been undertaken.
Actions To Be Taken:
Pending the completion of an investigation into the reasons for the adverse reactions seen in various European countries, and as a precautionary measure to safeguard animal welfare, the HPRA urges veterinary practitioners to:
• Use gentamicin in horses according to the approved conditions of use i.e. only for the treatment of infections of the lower respiratory tract that are caused by bacteria susceptible to gentamicin;
• Consider whether the expected benefits of treatment with gentamicin in individual horses outweigh the risks;
• Exercise caution when administering gentamicin to horses;
• Be prepared to administer anti-shock therapy in the event of an anaphylactoid-type reaction.
As normal, any unexpected adverse events that may arise following use of a veterinary medicinal product should be reported without delay to the marketing authorisation holder or to the HPRA.