July 15, 2021
Today, the U.S. Food and Drug Administration launched a new resource to improve transparency and communication with veterinarians, animal producers and consumers about safety-related labeling changes made to FDA-approved animal drug products. Awareness of these safety-related changes is essential for the safe use and administration of FDA-approved animal products.
The new resource is in the form of a webpage titled “Animal Drug Safety-Related Labeling Changes,” which provides information on recent safety-related labeling changes and will be updated on a monthly basis when changes to drug labeling are approved by the FDA. Safety-related labeling change information will be available on the webpage for two years after it is first listed. The webpage will only include safety-related labeling changes. For more information about the most current labeling for a particular animal drug, veterinarians should reach out to the drug’s sponsor.
Since the beginning of 2021, safety-related labeling changes have been approved for the animal drugs Apoquel, Osurnia, Claro, Terramycin 100MR, TM-100D, and TM-50D.
Apoquel's labeling revisions focus on the fact that the development of new neoplastic conditions (both benign and malignant conditions) have been reported in dogs administered Apoquel. The revised labeling now also advises veterinarians to consider the risks and benefits of treatment prior to prescribing Apoquel to dogs with a history of recurrent serious infections or recurrent demodicosis or neoplasms (benign or malignant conditions). The revised labeling also includes a section called the Post-Approval Experience section that lists the most important adverse drug events (side effects) reported in dogs since the product has been marketed.
The safety-related labeling changes for Osurnia and Claro warn that these ear products can cause irritation or injury if they get in human or animal eyes. Veterinarians and veterinary staff administering the product should wear appropriate eye protection and restrain dogs while administering the drug to avoid head shaking that could splatter the product on the people near them. Information was also added to emphasize that dogs should be carefully examined prior to administering the ear products because, in some cases, the product may injure the ear drum or ear canal. The revised labeling of these two products also include a Post-Approval Experience section.
The labeling for Terramycin 100MR, TM-10D, and TM-50D was updated to improve the clarity of the instructions for safe use in honey bees.
The FDA will alert the public to new safety-related labeling changes as they become available. You can subscribe to receive these email updates by clicking on the “Subscribe to Email Updates” button at the top of the CVM Updates page.
For more information:
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.