Reports of adverse reactions to imepitoin
Imepitoin was first authorised for use in February last year.
A number of reports of adverse reactions to imepitoin have been made over the past year, the Veterinary Medicines Directorate (VMD) has revealed.
Writing in the Veterinary Record (vol 175, no 9) Giles Davis and Gillian Diesel, of the VMD's pharmacovigilance unit, said the reports refer to both suspected adverse reactions and suspected lack of expected efficacy.
The unit is responsible for monitoring adverse reactions to veterinary medicines in the UK. These reports are made by veterinary surgeons, animal owners and marketing authorisation holders (MAH).
According to the joint letter published in Vet Record, the suspected adverse reactions to imepitoin often involved clinical signs similar to those listed in the summary of product characteristics (SPC).
After consulting with the MAH, Boehringer Ingelheim, the VMD says many of the reports regarding the product's lack of efficacy involved use not in strict accordance with the SPC. The directorate is reminding vets to refer to the SPC, particularly the indications for the use of the product.
Imepitoin was first authorised for use in February last year. It is authorised "for the reduction of the frequency of generalised seizures due to idiopathic epilepsy in dogs for use after careful evaluation of alternative treatment options."
In their letter to the Vet Record, Mr Davis and Dr Diesel clarify that the product is not authorised for treating seizures resulting from other causes. Imepitoin should only be used after consideration is given to other treatments for idiopathic epilepsy.
Patients should not be transitioned onto imepitoin from other treatments when the dog is stable and not suffering adverse effects on its current treatment regime.
The VMD also advises that imepitoin should not be used as the primary treatment and transition to other anti epileptic therapies should be done gradually under appropriate clinical supervision.
To view the SPC for imepitoin visit the European Medicines Agency website: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/veterinary/002543/WC500140840.pdf
To submit an adverse event report, visit the VMD's website: https://www.vmd.defra.gov.uk/adversereactionreporting/
Defra has published guidance for the vet sector ahead of a proposed UK-EU Sanitary and Phytosanitary agreement.
