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Was the flunixin withdrawal a sensible precaution or knee-jerk reaction?

BEVA has questioned the rationality behind the decision to withdraw flunixin and a potentiated sulphonamide

17 October 2018, at 9:14am

It is difficult to imagine a more important issue to equine veterinarians than medicines availability. Without the availability of such therapeutic substances, there is a serious and genuine risk to animal welfare. Of course, this availability of medicines must be balanced against a range of issues, and human safety has to be at the top of the list.

The equine profession faced such a challenge on 26 July 2018 when the Veterinary Medicines Directorate (VMD) suspended products for food-producing animals that contain the excipient diethanolamine (DEA). This cessation of the sale of all injectable formulations of the medicines was made without warning or consultation with the veterinary profession.

The VMD took the decision to suspend the medicines in light of the scientific opinion of the Committee for Medicinal Products for Veterinary Use, which is part of the European Medicines Agency. The committee was of the opinion that there may be a risk to humans from consuming food from animals treated with products containing DEA. It should be noted that the issue related to human safety of the solvent used in the injectable formulation, not the active ingredient.

Flunixin is used throughout the equine veterinary profession because of its highly potent analgesic effects. It is widely viewed as the gold-standard pain killer in horses and is commonly used in those undergoing both elective and emergency surgery, for the crippling pain associated with laminitis and for severe forms of colic. It is also the only medicine licensed for the treatment of sepsis (endotoxaemia).

BEVA made immediate representation to the VMD and via press releases, in an attempt to remedy the situation and uphold equine welfare. We issued the following statement:

“BEVA is calling on the VMD to immediately enable limited batch release of flunixin for use in horses not destined for the human food chain in the interests of animal welfare. The equine veterinary profession has always been open to consultation with the VMD on a range of important matters relating to responsible medicine use, antibiotic resistance, horse identification, passports and the horse meat issue. BEVA is perplexed as to why the VMD failed to consult with the equine veterinary industry on the animal welfare impact of withdrawing such an important drug.”

Another product suspended by the VMD was an injectable formulation of potentiated sulphonamide, one of the few licensed antibiotics available that can be used both enterally and parenterally, allowing for rapid establishment of minimum inhibitory concentrations following injection. Subsequently, horse owners can administer it orally. Its use is important in the maintenance of the health of horses and donkeys in the UK. BEVA recognises that other formulations of this medicine remain available and is hopeful that the supply chain of this important first line antibiotic is not disrupted by this suspension.

BEVA is a strong advocate of antimicrobial stewardship through our PROTECT ME toolkit, which encourages limited use of these critically important antimicrobials. We were the first veterinary organisation to receive an “Antibiotic Guardian Award” from Public Health England in recognition of this initiative.

If the supply chain of potentiated sulphonamides was disrupted, it could have significant impacts on human health by driving unnecessary use of critically important antibiotics; especially the flouroquinolones (specifically, enrofloxacin, which is the only other antibiotic that can be used both enterally and parenterally in the horse, albeit under the prescribing cascade). It would be ironic if a measure designed to promote human health through the animal food chain actually risked human health through antimicrobial resistance.

BEVA strongly argued that mechanisms already exist within horse passport legislation that would allow the use of products such as flunixin in horses not intended for human consumption. This could certainly be alongside a “caution in use” statement outlining the conditions of use and restricting supply to non-food horses. Due to the strong and swift representations made by BEVA, the suspension of flunixin was lifted in mid-August.

Jonathan Pycock is an equine claims consultant for the Veterinary Defence Society and an equine reproduction expert. He is the immediate past president of the British Equine Veterinary Association.

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