The veterinary medicine Kexxtone suspended across the European Union

On 23 April 2024, the EMA’s veterinary medicines committee, CVMP, completed a review recommending the suspension of the marketing authorisation of Kexxtone in the European Union.

This veterinary medicine contains the active substance monensin and it is intended for the reduction in the incidence of ketosis in dairy cows and heifers which are expected to develop ketosis in the period around calving. Ketosis is a metabolic disturbance in which blood glucose levels are low and substances called ketones accumulate in the blood; it leads to loss of appetite and low milk production.

Kexxtone is a continuous-release intraruminal device (a device administered through the animal’s mouth and placed within the rumen, or first stomach of cattle). Continuous-release means that monensin is released slowly from the device, which consists of a core fitted with wings and containing a stack of 12 monensin tablets.

The review was initiated in March 2024 after a quality defect procedure showing deficiencies in the quality of Kexxtone, resulting in cases where cattle regurgitated the device while still containing undissolved monensin tablets. This resulted in increased accidental exposure, including deaths, in non-target species (dogs) as monensin is toxic to them. In addition, failures in the scheduled release of the tables from the device to the treated cattle led to concerns over lack of efficacy in those animals.

Having reviewed all available data, the CVMP concluded that the benefit-risk balance of Kexxtone is no longer positive and recommended that the marketing authorisation in the EU should be suspended until the marketing authorisation holder of Kexxtone implements corrective and preventive actions to address the quality defect. In addition, to prevent accidental exposure and minimise the risk of adverse events in non-target species, all batches of Kexxtone should be recalled from the market to veterinarian level.

Animal Healthcare Professionals should no longer use Kexxtone and consider other appropriate alternatives.

The CVMP opinion was sent to the European Commission, which endorsed it and issued a final legally binding decision on 15 May 2024.