Kexxtone: suspension of marketing authorisation and recall of all batches

date: 08/07/2024

The EMA's Committee for Veterinary Medicinal Products (CVMP) recommends suspending the marketing authorisation for Kexxtone 32.4 g continuous-release intraruminal device for cattle (EU/2/12/145/001-003) and recalling batches from the market.

Kexxtone is a veterinary medicine containing the active substance monensin. It was approved in 2013 and aims to reduce the incidence of ketosis in periparturient dairy cows/heifers at risk of developing ketosis.

The suspension of Kexxtone's marketing authorisation was due to a quality defect that led to cases of regurgitation of the device when it contained undissolved tablets. This has led to increased accidental exposure, including fatalities, in non-target species (dogs) and a potential lack of efficacy in cattle.

The suspension of the European Union marketing authorisation is effective until Elanco GmbH implements corrective and preventive measures to remedy this quality defect.

Animal health professionals should no longer use Kexxtone and should consider other suitable alternatives. Veterinarians are asked to inform their customers of these potential risks.

To minimise the risk of exposure to non-target species, all lots of Kexxtone are being recalled from the market up to veterinarians as a precautionary measure. This recall will begin on May 29, 2024 to allow for the implementation of manufacturing modifications and additional quality control tests.

The direct animal healthcare professional communication (DaHPC (FR/NL)) has been sent and provides additional information on this subject.

The reporting of adverse events remains important, enabling ongoing monitoring of veterinary drug safety.

Consequently, if breeders notice any side effects, even those already mentioned in the leaflet, or if they think that the medication has not been effective, please advise them to contact their veterinarian in the first instance.

Any suspected adverse reaction can be reported via the national reporting system (FR/NL) for the veterinary medicinal products concerned or to the marketing authorisation holder.

Last updated on 08/07/2024