UK veterinary regulatory authorities have confirmed that histamine contamination in specific batches of Genta-Equine 100 mg/ml Solution for Injection caused adverse events in horses, following a comprehensive investigation by the Marketing Authorisation Holder (MAH). The contamination was identified in batches T-001 and V-001 at concentrations sufficient to trigger the reported adverse reactions.
Investigation Findings Confirm Root Cause
The MAH's investigation, conducted after initial notification on December 18, 2024, definitively established histamine presence as the most likely root cause of the adverse events. The contamination levels were deemed sufficient to cause the range of symptoms reported by veterinary professionals across the UK.
Franklin Pharmaceuticals, the product manufacturer, and their UK distributor Dechra have been working closely with regulatory authorities to address the contamination issue and monitor ongoing reports.
Regulatory Response and Recall Status
While recalls of the affected batches have been initiated in Denmark and Belgium, UK authorities have not implemented a recall due to the critical nature of Genta-Equine for equine veterinary practice. This decision reflects the essential role the antibiotic plays in equine healthcare, where alternative treatments may not be readily available.
Dechra has advised veterinary professionals concerned about using the affected batches to consider treatment with alternative appropriate antibiotics. The company has also confirmed that refunds are available for any unopened bottles of the contaminated batches.
Clinical Presentation and Recovery
Adverse event reports documented a consistent pattern of symptoms that developed within minutes of administration. The clinical signs included abdominal pain and colic, pawing behavior, restlessness and agitation, groaning, shaking, shivering, and fasciculation. Additional symptoms comprised the Flehmen response, attempts to lie down, staggering, increased sweating, and elevated respiratory rate.
Importantly, all horses affected by the contaminated batches recovered completely from their adverse reactions. The rapid onset of symptoms, occurring within minutes of injection, was consistent with histamine-mediated reactions.
Ongoing Monitoring and Reporting
UK veterinary authorities continue to work with the MAH to monitor adverse event reports and ensure appropriate actions are implemented as required. The regulatory body has approved further communications from Dechra to veterinary surgeons, providing updated information about the investigation findings and recommended actions.
Veterinary professionals are strongly encouraged to report any suspected adverse events directly to the MAH, providing all relevant information including batch numbers. Contact details for Franklin Pharmaceuticals or their local representatives can be found on product leaflets or through the official Product Information Database.
The case highlights the importance of robust pharmacovigilance systems in veterinary medicine and the need for rapid investigation and communication when product quality issues arise that could impact animal health and welfare.
