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FDA reports inadvertent eye issues involving Osurnia, Claro

Formulated for canine ears, the medications can irritate the eyes of people and dogs.

FDA reports inadvertent eye issues involving Osurnia, Claro

Anyone administering the canine ear infection drugs Claro or Osurnia should take care to avoid contact with eyes, the U.S. Food and Drug Administration is advising.

The agency on Dec. 6 reported a number of adverse events after the medications accidentally got into the eyes of dogs or people.

The gel medication Osurnia (florfenicol/terbinafine/betamethasone acetate) reportedly caused corneal ulcers in 10 dogs and two veterinary technicians as of Oct. 17, the FDA stated. Claro (florfenicol/terbinafine/mometasone furoate), a clear liquid, was linked to 10 reports of corneal ulcers in dogs.

“In some reports, the eye injuries occurred after the medication was applied to the ear(s) and the dog shook its head,” the FDA noted. “Other reports simply state that medication splashed into the eyes of the person.”

An undisclosed number of veterinary professionals and pet owners “who were near the dog during or after application of Osurnia or Claro” complained of eye irritation or burning, the FDA added.

Osurnia’s manufacturer, Elanco Animal Health, stated that the company “is committed to the safety of dogs using our products and the people administering them.”

“In this instance, the cases were detected by Elanco’s own pharmacovigilance monitoring and immediately reported to the FDA,” Elanco stated. “We will continue our aggressive monitoring program and are currently assessing what further steps may be needed to assist clinicians in best practice management.

“Osurnia’s warning contained within the U.S. label states to avoid eye contact, and in the event of accidental skin contact, instructs that the area should be washed thoroughly with water.”

Bayer Animal Health, which makes Claro, noted that the medication has been in widespread use since its introduction in 2015.

“Bayer has sold over 1.5 million doses of Claro to veterinary clinics across the U.S., treating more than 750,000 dogs,” the company reported.

“To date, zero reports of corneal ulcers have been reported in people associated with the use of Claro.”

Like the FDA, Bayer advised that care be taken to avoid eye injuries.

“If accidental exposure to the eyes of people or dogs occurs, seek medical care,” Bayer added.

The company pointed out that Claro and Osurnia differ in one active ingredient, their inactive ingredients and the labeled dosing regimen.