Ketosis veterinary medicine Kexxtone suspended for use

The veterinary medicine Kexxtone, which is used to reduce the incidence of ketosis in dairy cows and heifers, has been suspended for use in the UK.

The EU suspended the marketing authorisation for Kexxtone in May following a recommendation from the European Medicines Agency (EMA), and batches released across the EU were recalled as a precautionary measure.

Last week, UK regulator the Veterinary Medicines Directorate (VMD) followed up with its own suspension of the product for use in dairy cows in Great Britain.

See also: Guide to preventing ketosis and fatty liver in dairy cows

Kexxtone is administered as a bolus containing the ionophore monensin, and a quality defect resulted in cases where cattle regurgitated the device while it still contained the drug.

However, there is no safety concern with the product already in cows. 

Defra said it had issued a recall notice with immediate effect for all in-date batches, which contained advice on what steps to take for those affected.

Elanco, the marketing authorisation holder, has committed not to resupply the product until corrective actions are in place and approved.

The affected batches have been quarantined and release of further product onto the market has been halted until the quality issues have been resolved.

Manufacturing issue

Elanco said the problem was related to a change in the manufacturing process which increased the risk of boluses, still containing the tablets, being regurgitated.

A spokesperson for Elanco said: “There is no risk to the dairy cows that have received a bolus. We just ask that, as always, any regurgitated boluses are picked up and disposed of in a safe place.

“Elanco is fully committed to resolving this concern given the importance of this tool to farmers and to the health and well-being of dairy cows and we are working to get Kexxtone back on the market as soon as possible.”