Kexxtone 32.4 g continuous release intraruminal device for cattle (monensin) from Elanco GmbH – Suspension of marketing authorisation

Regurgitation of Kexxtone boluses with incomplete payout have been linked to adverse events including deaths in dogs in the EU, as well as potential lack of efficacy in treated animals. On 15 May 2024 the European Commission suspended the marketing authorisation for the product and ordered a recall of product from the market.

Problem or issue

Regurgitation by cattle of Kexxtone boluses that still contain monensin tablets has led to concerns over lack of efficacy in cows and an increase in accidental exposure in non-target species including to dogs.  There are no reports of toxicity in dogs in Ireland.

In April 2024, the EMA’s committee for veterinary medicines (CVMP) recommended the suspension of the marketing authorisation for Kexxtone and recall of the product. That action was confirmed by the EU Commission on 15 May 2024. The marketing authorisation will remain suspended until Elanco implements corrective and preventive measures to address this quality defect.

Background information

Regurgitation of boluses in cattle is a known feature, however, in this case due to concerns of incomplete payout and as monensin is toxic to non-target species and especially in dogs, horses, other equines and guinea fowl, it is important to monitor their use and to recover any regurgitated boluses in order to prevent access to them.

Given the opinion of the CVMP on 23 April 2024 that the benefit-risk balance has changed and subsequent decision of the EU Commission to suspend the marketing authorisation and order a recall of the product from the market, the HPRA wishes to raise awareness of veterinary practitioners and farmers regarding the position.

For background information on Kexxtone please click here. 

Further Information

This notice may be updated if further information become available.

Actions to be taken

Veterinary Practitioners should be aware that the EU Commission has suspended the centralised marketing authorisation for Kexxtone due to deficiencies in quality, leading to a potential lack of efficacy in cattle and to an increase in reported adverse events in dogs, a non-target species. The HPRA advises veterinarians to be mindful of the risk of monensin toxicity in animals that might have arisen from exposure on dairy farms.

Farmers: Where cows and heifers have been treated with Kexxtone, farmers should monitor collecting yards, passageways, and pastures for regurgitated boluses. Using gloves, regurgitated boluses should be collected and put in a medical waste bin on the farm and kept out of reach of children, animals, and birds.