European Medicines Agency advises application caution after ocular damage from accidental exposure to popular otitis externa treatment reported.
The patented gel formulation – from Elanco Europe – is indicated for the treatment of otitis externa in canines and contains the active substances terbinafine, florfenicol and betamethasone acetate.
An EMA release stated: “Eye exposure in people mostly happened when the dog shook its head during – or just after – applying the medicine.
“It is not clear if cases in dogs were also due to accidental contact, although this was confirmed in a few reports.
“The injuries in people include two cases of corneal ulcer, as well as reports of eye irritation, conjunctivitis, redness, burning, stinging and itchiness.
“The eye injuries in dogs included corneal ulcers, squinting, impaired vision, conjunctivitis, redness and swelling around the eye.”
Report side effects
The release continued: “Care should be taken to prevent Osurnia ear gel from contacting the eyes of people or dogs. If accidental exposure occurs, the eyes should be thoroughly rinsed with water and medical care sought.
“Veterinary health care professionals will be informed in writing of this issue and are encouraged to report any suspected side effect to the relevant national authority or the company for Osurnia.”
EMA advice for veterinary health care professionals states:
- Before Osurnia is applied to dogs, veterinary health care professionals should examine the external ear canal to ensure the eardrum is not perforated.
- Vets should advise pet owners to take care when applying the medicine. The dog should be properly restrained during administration of Osurnia and appropriate measures should be taken to avoid accidental eye contact with the product.
- If accidental ocular exposure occurs, the eyes should be flushed thoroughly with water for 10 to 15 minutes.
- Vets should also advise pet owners to monitor dogs treated with Osurnia and contact their vet in case of any side effects – in particular, those affecting the eyes.
- Side effects relating to Osurnia should be reported to the appropriate local authorities or company that markets Osurnia, Elanco Europe.