17 Aug 2021
Directorate issues warnings after continued reports of adverse events occurring in cats involving Osurnia, which is licensed for treatment of otitis externa in dogs.
Paul Imrie
Job Title
The VMD says it is receiving reports of adverse events occurring in cats following off-label use in cats of Osurnia ear gel.
Osurnia is licensed for use in dogs for the treatment of acute otitis externa and acute exacerbation of recurrent otitis externa associated with Staphylococcus pseudintermedius and Malassezia pachydermatis. It contains terbinafine, florfenicol and betamethasone.
Despite an update to warnings on its summary of product characteristics (SPC), the VMD said it continued to receive reports of adverse events due to off-label use in cats.
Under a “special precaution for use” in section 4.5 of the SPC, it states: “The safety and efficacy of the veterinary medicinal product in cats has not been evaluated. Post-marketing surveillance shows that the use of the product in cats can be associated with neurological signs (including Horner’s syndrome with protrusion of membrane nictitans, miosis, anisocoria, and internal ear disorders with ataxia and head tilt) and systemic signs (anorexia and lethargy).
“The use of the veterinary medicinal product in cats should therefore be avoided.”
In a letter sent to Vet Times, Anne-Sophie Kennedy of the VMD’s pharmacovigilance, surveillance division said it was important vets completed a full risk:benefit analysis and obtained informed consent prior to off-label use of Osurnia in cats, in accordance with the cascade.
She added it was critical to the ongoing safety review of vet medicines that vets reported adverse reactions using the VMD’s online reporting form, including full details of any products administered prior to the adverse event.
