On December 6th, 2017, FDA Center for Veterinary Medicine issued a warning about eye irritations and injuries reported with the use of two different ear medications in dogs. One of these medications is Claro® (florfenicol, terbinafine, mometasone furoate) Otic Solution, a single-dose treatment regimen, applied by a veterinarian to help treat otitis externa. Marketed and manufactured by Bayer, Claro® is an FDA-approved drug that has been on the market for over two years.
Since launch, Bayer has sold over 1.5 million doses of Claro® to veterinary clinics across the U.S., treating more than 750,000 dogs. Also in the first two years since launch, as the press release from the FDA indicates, there have been 10 reports of corneal ulcers in dogs. To date, zero reports of corneal ulcers have been reported in people associated with the use of Claro®.
Bayer is committed to the safety of dogs using our products and the people administering them. Bayer as well as the FDA advise professionals administering Claro® to take care to prevent the medication from contacting their eyes, or the eyes of other people nearby.If contact with eyes occurs, flush copiously with water. If irritation persists, contact a physician. Precautions should also be taken to prevent medication getting in the eyes of the dog being treated. Reducing the potential for splatter of product will help prevent accidental eye exposure in people and dogs and help to prevent ocular injury.
It is important to note that while two products were specifically mentioned in the release, not only do the adverse events reported differ by product, but the products themselves are also substantially different, varying in three ways:
- An active ingredient
- Inactive ingredients
- Labeled dosing regimen
Bayer is working with the FDA to continue to monitor these reports and encourage veterinary professionals and pet owners to report adverse drug events to the manufacturer of the drug. To report an adverse event, please call 1-800-422-9874.
CAUTION: Federal (U.S.A.) Law restricts this drug to use by or on the order of a licensed veterinarian. Important safety information: Do not administor orally. Claro® should not be used in dogs that are known or suspected to be allergic to florfenicol, terbinafine hydrochloride, or mometasone furoate. Claro® should be used with caution in dogs with liver disease.