Genta-Equine 100 mg/ml Solution for Injection for Horses – Adverse events
Increase in suspected adverse event reports following use of Genta-Equine 100 mg/ml Solution for Injection for Horses.
We wish to raise awareness of an increase in suspected adverse event reports following use of Genta-Equine 100 mg/ml Solution for Injection for Horses, specifically batches T-001 and V-001.
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
- 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.
We are working with the companies responsible for the product (Franklin Pharmaceuticals and their distributor Dechra) to investigate these findings and closely monitor reports.
We have also approved a communication from Dechra to veterinary surgeons which provides further information on the events that have been seen, the outcome of the events and investigations that are being carried out.
You will find the Summary of Product Characteristics (SPC) for all veterinary medicinal product authorised for marketing in the UK on our Product Information Database.
No medicine is 100% risk free, the SPC includes information on what adverse events have been known to occur following administration of a particular product, these can be found in section 4.6.
All safety updates to SPCs, including section 4.6, are published on the Veterinary Practice and Supply page under the Medicine Updates section of VMD Connect.
Reporting of adverse events
We strongly encourage anyone who is aware of an adverse event to report directly to the Marketing Authorisation Holder. Please provide all relevant information, including the batch number.
Contact details for the Marketing Authorisation Holder 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.