Kexxtone 32.4 g continuous-release intraruminal device for cattle (monensin): marketing authorisation suspension and market recall of all batches
On 23 April 2024, the Committee for Veterinary Medicinal Products (CVMP) of the European Medicines Agency (EMA) decided by consensus to recommend suspending the marketing authorization of “Kexxtone - Monensin sodium” and to recall batches that have been released in the Union. The European Commission has now followed this opinion and issued a corresponding implementing decision on 15 May 2024. Animal Healthcare Professionals should no longer use Kexxtone and consider other appropriate alternatives.
Date: 04.06.2024
Summary
- The marketing authorisation of Kexxtone has been suspended due to a quality defect which has resulted in cases where cattle regurgitated the device while it still contained monensin tablets. This resulted in increased accidental exposure, including deaths, in non-target species (dogs) and potential lack of efficacy in cattle.
- Kexxtone 32.4 g continuous-release intraruminal device for cattle has now been suspended from the EU market until the marketing authorization holder Elanco implements corrective and preventive actions to address this quality defect.
- To minimise the risk of exposure to non-target species, all batches of Kexxtone will be recalled from the market. This recall will begin on 27.05.2024 to allow for manufacturing changes and additional quality control testing to be implemented.
- Animal Healthcare Professionals should no longer use Kexxtone and consider other appropriate alternatives.
Background information
Kexxtone 32.4 g continuous-release intraruminal device for cattle is a veterinary medicinal product (VMP) containing the active substance monensin. It was authorised in 2013 and is intended for the reduction in the incidence of ketosis in the peri-parturient dairy cow/heifer which is expected to develop ketosis.
Kexxtone is a controlled-release formulation of monensin sodium in tablet form which is enclosed in a polypropylene delivery device. The device is intended to be retained in the rumen for at least the duration of the approximately 95-day payout period.
Due to a change in manufacturing process, a quality defect arose that led to an increase in regurgitation of boluses by cattle that still contained monensin tablets. This led to concerns over lack of efficacy in cattle and increased risk of accidental exposure to regurgitated Kexxtone devices by non-target species, with a corresponding link to death in dogs. Following assessment of all available data related to this quality defect, EMA’s Committee for Veterinary Medicinal Products (CVMP) recommended the suspension of the marketing authorisation for Kexxtone (EU/2/12/145/001-003) until enhanced manufacturing control testing can be identified to confirm the release rate and minimise the risk of accidental exposure in non-target species from a regurgitated bolus.
To prevent accidental exposure and minimise the risk of adverse events in non-target species, all batches of Kexxtone are being recalled from the market to veterinarian level as a precautionary measure.
The market recall in Germany relates to the following batches of Kexxtone:
| Land | Charge | Verfalldatum |
|---|---|---|
| Deutschland | 504995-2 | 06-2024 |
| Deutschland | 504995-3 | 06-2024 |
| Deutschland | 505099-1 | 08-2024 |
| Deutschland | 505100-1 | 08-2024 |
| Deutschland | 505174-1 | 02-2025 |
| Deutschland | 505175-1 | 02-2025 |
| Deutschland | 505204-1 | 03-2025 |
| Deutschland | 505205-1 | 03-2025 |
| Deutschland | 505450-1 | 08-2025 |
| Deutschland | 505451-1 | 08-2025 |
| Deutschland | 505601-1 | 12-2025 |
| Deutschland | 505651-1 | 02-2026 |
| Deutschland | 505084-1 | 07-2024 |
| Deutschland | 505085-1 | 07-2024 |
| Deutschland | 505086-1 | 07-2024 |
| Deutschland | 505093-1 | 07-2024 |
| Deutschland | 505094-1 | 07-2024 |
| Deutschland | 505096-1 | 07-2024 |
| Deutschland | 505102-1 | 08-2024 |
| Deutschland | 505151-1 | 09-2024 |
| Deutschland | 505176-1 | 02-2025 |
| Deutschland | 505178-1 | 02-2025 |
| Deutschland | 505179-1 | 02-2025 |
| Deutschland | 505182-1 | 02-2025 |
| Deutschland | 505183-1 | 02-2025 |
| Deutschland | 505207-1 | 03-2025 |
| Deutschland | 505323-1 | 04-2025 |
| Deutschland | 505397-1 | 06-2025 |
| Deutschland | 505406-1 | 06-2025 |
| Deutschland | 505415-1 | 06-2025 |
| Deutschland | 505416-1 | 06-2025 |
| Deutschland | 505435-1 | 07-2025 |
| Deutschland | 505454-1 | 08-2025 |
| Deutschland | 505619-1 | 02-2026 |
| Deutschland | 505621-1 | 02-2026 |
| Deutschland | 505650-1 | 02-2026 |
| Deutschland | 505653-1 | 03-2026 |
| Deutschland | 505719-1 | 03-2026 |
| Deutschland | 505738-1 | 07-2026 |
| Deutschland | 505783-1 | 11-2026 |
The marketing authorization holder Elanco is currently working in close collaboration with the European Medicines Agency to resolve this concern and to get Kexxtone back on the market.
Call for reporting
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product.
If farmers notice any side effects, even those already listed in the package leaflet for Kexxtone, or think that the medicine has not worked, they should contact, in the first instance, their veterinarian. Any adverse events can be reported to the marketing authorisation holder using the contact details given below or at the end of the package leaflet, or via the national reporting system:
Elanco-Pharmakovigilanz
Email: PV.DEU@elancoah.com
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL)
Adverse event reporting forms and contact details of the BVL can be found on the website https://www.vet-uaw.de/ or can be requested by e-mail (uaw@bvl.bund.de). Veterinarians have the option of electronic reporting on the above-mentioned website.
The information provided should contain at minimum the product identification number (visible on barrel) and administration date to the animal.
Company contact point (Elanco Deutschland GmbH)
Kundenbetreuung für logistische Fragen:
Tel. 0800 / 453 48 47
Fax 0800 / 723 40 83
E-Mail-Adresse: kundenbetreuung@elancoah.com
Veterinärmedizinische Fachberatung für technisch-wissenschaftliche Fragen:
Telefon: 0800 / 453 40 00
E-Mail: TC_Hotline_DE@elancoah.com
Contact information of the state authority responsible for the recall
Staatliches Gewerbeaufsichtsamt Lüneburg
Auf der Hude 2, 21339 Lüneburg
Telefon: 04131 / 151448
Fax: 04131 / 151403
E-Mail: amg@gaa-lg.niedersachsen.de
Year of issue
2024
Date
04.06.2024
Pressekontakt
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL)
Presse und Öffentlichkeitsarbeit •
Gerichtstraße 49 •
13347 Berlin
Phone: 030 18444 -88250
• Fax: 030 18444 -89999
E-Mail: *
presse@bvl.bund.de