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August 01, 2021

In video, FDA urges adverse event reporting

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Whenever an animal drug is linked to an adverse event—in an animal or a person—Food and Drug Administration officials want to know about it.

In June, FDA officials released a new video to educate veterinarians and animal owners about why they should report any adverse events linked with use of animal drugs and how they can do so.

Dr. Linda Walter-Grimm, acting director of the Division of Veterinary Product Safety in the FDA Center for Veterinary Medicine, said adverse event reports are an important way that agency officials learn about animal drug safety, efficacy, and quality. But any such reporting system that relies on volunteer submissions tends to have substantial underreporting.

She noted that previous studies found that clinicians in human medicine reported 5%-10% of adverse events, and she noted that one scientific article published in 2018 in the Annals of Pharmacotherapy describes a 2% rate of filing reports to the FDA in response to adverse events linked with dietary supplements.

Dr. Walter-Grimm also noted an article published in 2017 in Veterinary Record Open that describes results of a survey of 3,545 veterinarians by the Federation of Veterinarians of Europe. The survey results indicated the typical veterinarian saw about one adverse event in every 100 treatments given yet reported less than one adverse event per year.

The video starts with hypothetical examples from the perspectives of pet owners, one whose cat vomited after receiving a new oral medication and another who went to an urgent care center with eye irritation after her dog shook its head and sent drops of ear medicine flying.

The video’s narrator, Heather Tate, PhD, of the FDA Center for Veterinary Medicine, states: “CVM’s veterinarians and animal scientists want to know about these incidents, so it’s important to report them. With any side effect, our first priority is the safety of you and your animal.”

The agency recommends veterinary professionals and animal owners report side effects to drug manufacturers, which are required to further report the incidents to the CVM.