Since our initial notification on 18 December 2024, the Marketing Authorisation Holder (MAH) has provided findings of their investigation into adverse event reports relating to the use of Genta-Equine 100 mg/ml Solution for Injection for Horses, specifically batches T-001 and V-001.
The MAHs investigation has confirmed the presence of histamine in batches T-001 and V-001 at concentrations deemed sufficient to cause the adverse events received. Therefore, it has been concluded that this is the most likely root-cause for the adverse events.
A recall of affected batches has been initiated in Denmark and Belgium but due to the critical nature of Genta-Equine to equine veterinary surgeons in the UK, a recall has not been initiated in the UK.
Dechra (UK distributor) has advised that if veterinary professionals are concerned about using the affected batches of Genta-Equine, treatment with an alternative appropriate antibiotic should be considered. They have also advised that a refund can be received for any unopened bottles.
We have approved a further communication from Dechra to veterinary surgeons including this information and will continue working with the MAH to monitor reports and ensure appropriate actions are carried out as required.
Symptoms included in adverse event reports
These reports include signs of abdominal pain/colic, pawing, restlessness/agitation, groaning, shaking/shivering/fasciculation, Flehmen response, lying down or attempting to lie down, staggering, increased sweating and increased respiratory rate.
In all reports received to date, events commenced within minutes of administration and all horses recovered.
Adverse event reports received may include reports where more than one product was used, the product was used off-label and/or where, on further evaluation, it is considered that there is no causal association between the product and event.
Reporting of adverse events
We strongly encourage anyone who is aware of an adverse event to report directly to the MAH. Please provide all relevant information, including the batch number.
Contact details for the MAH or their local representative can found be on the product leaflet or on the Product Information Database.
The reporting of adverse events is critical to our ongoing monitoring activities in order to protect animal health, public health, and the environment. Find out more about pharmacovigilance at VMD Connect – Adverse Events and Pharmacovigilance.
