FDA Warns Dog Ear Meds May Harm Human & Dog Eyes

Canine ear medications Osurnia­® and Claro® have been reported to cause eye injury and irritation in both people and dogs following application to the dogs, according to a Dec. 6, 2017, alert from the U.S. Food and Drug Administration.

Osurnia® and Claro® are FDA-approved prescription drugs used to treat ear infections in dogs, and are intended to be administered by veterinary medical professionals. Both drugs contain the antibacterial drug florfenicol and the antifungal drug terbinafine, coupled with different steroidal anti-inflammatory drugs.

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

In humans, there have been two reports of corneal ulcers following accidental eye exposure to Osurnia®. There have been no reports of corneal ulcers in people associated 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, or others who were near the dog during or after application of Osurnia® or Claro® to the dog’s ear(s).

In dogs, 10 reports of corneal ulcers associated with the use of Osurnia®, and 10 reports associated with the use of Claro® were reported. Other clinical signs reported in dogs include eye irritation, conjunctivitis, squinting and eye pain after application of Osurnia® or Claro® to their ears.

The FDA advises people administering Osurnia® and Claro® to take care to prevent these medications from contacting their eyes or the eyes of other people nearby. Precautions should also be taken to prevent medication getting in the eyes of the dog being treated. If accidental exposure to the eyes of people or dogs occurs, seek medical care.

The FDA continues to monitor these reports and encourages veterinary professionals and pet owners to report adverse drug events to the manufacturer of the drug. The manufacturer is in turn required to report this information to the FDA.

To report suspected adverse drug events for Osurnia®, contact Elanco US Inc. at 1-888-545-5973.
To report suspected adverse drug events for Claro®, contact Bayer HealthCare at 1-800-422-9874.

Click here to view the original FDA Animal Drug Safety Communication posted on December 6, 2017.

Post photo by Mitchell Orr on Unsplash.