Eye injuries associated with application of Osurnia and Claro, FDA warns

The FDA has issued an alert to veterinary professionals and pet owners about reports of eye injury and irritation in both people and dogs after the application of canine ear medications Osurnia (Elanco) and Claro (Bayer) to dogs, the agency states in a release.

The drugs are FDA-approved to treat ear infections and are intended to be administered by veterinary professionals. Each contains the antibacterial drug florfenicol and the antifungal drug terbinafine, combined with a different steroidal anti-inflammatory drug.

Most of the exposures have occurred during or shortly after application of the medication to the dog's ear or ears, the FDA states. In some reports the eye injuries happened after the product was applied and the dog shook its head. Other reports state that the medication splashed into the person's eyes, according to the release.

As of October 17, the FDA had received two reports of corneal ulcers in people, both veterinary technicians, after accidental eye exposure to Osurnia. To date, no reports of corneal ulcers have been reported with the use of Claro; however, other injuries such as eye irritation, redness, burning, stinging and itchiness have been reported in veterinary personnel, pet owners and others who were near the dog after application of Osurnia or Claro to the dog's ears, the agency says.

The FDA has also received 10 reports of corneal ulcers in dogs associated with the use of Osurnia and 10 reports associated with the use of Claro. Other clinical signs reported include eye irritation, conjunctivitis, squinting and eye pain after application of the medications to dogs' ears.

The FDA is advising people administering Osurnia and Claro to take care to prevent contact of these medications to their eyes and the eyes of people nearby. Precaution should also be taken to prevent the medication from getting into the patient's eyes. If accidental exposure occurs, seek medical care, the release advises.

Veterinary professionals and pet owners are encouraged to report adverse drug events to the manufacturer at the numbers below. The manufacturer is then required to report these events to the FDA, the release states.

To report adverse drug events for Osurnia, call Elanco at (888) 545-5973.

To report adverse drug events for Claro, call Bayer at (800) 422-9874.