Kexxtone 32.4 g continuous-release intraruminal device for cattle. Monensin New
Summary
The BASG draws attention to the suspension of the marketing authorization of Kexxtone 32.4 g continuous-release intraruminal device for cattle (EU/2/12/145/001-003) containing the active substance monensin in the European Union in May 2024 due to a quality defect. The quality defect has resulted in cases where the treated cattle regurgitated the bolus containing monensin tablets more frequently, which led to efficacy concerns. Additionally, there were cases of accidental ingestion of the bolus by dogs, including deaths. To prevent accidental exposure to non-target species, all batches of the veterinary medicinal product were recalled from the market.
Background information
The veterinary medicinal product Kexxtone was authorized in the EU in 2013 and is intended for the reduction in the incidence of ketosis in the peri-parturient dairy cows/heifers which is expected to develop ketosis.
Kexxtone consists of a polypropylene cylinder containing tablets from which monensin sodium is released in a controlled manner. The bolus is intended to be retained in the rumen for at least the duration of the approximately 95-day release period, which was no longer guaranteed due to the quality defect.
For this reason, the Committee for Veterinary Medicinal Products (CVMP) was asked to evaluate the benefit-risk ratio of Kexxtone and, after evaluating all available data, recommended the suspension of the veterinary medicinal product until the quality defect has been solved.
Veterinarians should therefore no longer use Kexxtone and consider other appropriate alternatives.
Additionally, please report any adverse reactions, including suspected lack of efficacy, associated with the use of Kexxtone to the Federal Office for Safety in Health Care.
Further information:
Publication of the EMA:
Kexxtone 32.4 g continuous-release intraruminal device for cattle - referral | European Medicines Agency (europa.eu)
Recall information:
Kexxtone 32.4 g continuous-release intraruminal device for cattle. Monensin - BASG
Adverse reaction reporting form:
Online reporting of adverse reactions veterinary - Start - BASG
