FDA warns of eye injuries with use of canine ear medications

On Dec. 6, 2017, the Food and Drug Administration issued an alert about reports of eye injury and irritation in people and dogs following application of the canine ear medications Osurnia or Claro to dogs.

Osurnia and Claro are FDA-approved prescription drugs that are used to treat ear infections in dogs and are intended to be administered by veterinary professionals.

Most reports in people describe eye exposures as occurring during or closely following application of these medications to a dog's ears. In some reports, eye injuries occurred after the medication was applied and the dog shook its head. Other reports simply state that the medication splashed into the person's eyes.

As of Oct. 17, the FDA had received two reports of corneal ulcers in people, both veterinary technicians, following accidental eye exposure to Osurnia. Other injuries, such as eye irritation, redness, burning, stinging, and itchiness, have been reported in veterinary personnel, pet owners, or others who were near a dog during or after application of Osurnia or Claro to the dog's ears.

Also as of Oct. 17, the FDA had received 10 reports of corneal ulcers in dogs associated with the use of Osurnia and 10 reports associated with the use of Claro. Other adverse effects reported for dogs include eye irritation, conjunctivitis, squinting, and signs of eye pain after application of Osurnia or Claro to the ears.

To report suspected adverse drug events for Osurnia, contact Elanco at 888-545-5973. For Claro, contact Bayer HealthCare at 800-422-9874. The manufacturer is in turn required to report this information to the FDA.