What an adverse event report is, and is not
Last checked against the FDA pages:
An adverse event report tells the FDA Center for Veterinary Medicine (CVM) about a problem with an animal drug or device. The site counts these reports. The data have 1,378,761 of them, received from January 1987.
The site read the FDA pages for this guide on .
What FDA counts as an adverse event
Problems include undesired side effects (adverse events) associated with a drug, and product defects. Adverse events also include a lack of effectiveness (the drug doesn’t do what it’s supposed to do) and unfavorable reactions in people who handle the drug.
FDA Center for Veterinary Medicine. Source: Frequently Asked Questions about Animal Drugs
FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices
Who sends a report
The FDA encourages veterinarians and animal owners to report adverse events associated with drugs or devices used in animals.
FDA Center for Veterinary Medicine. Source: How to Report Animal Drug and Device Side Effects and Product Problems
The company responsible for the approved or Indexed drug product(s) is required to submit reports of adverse drug events to FDA.
FDA Center for Veterinary Medicine. Source: How to Report Animal Drug and Device Side Effects and Product Problems
What a report contains
The openFDA record of a report has these coded items. The site counts all of them and shows no other item.
- The drugs that the animal got, with their active ingredients.
- The clinical signs, coded with terms.
- The species, breed, age and weight of the animal.
- The outcome that the reporter gives.
- The kind of report: a safety issue, a lack of expected effectiveness, or a product defect.
- The date on which FDA received the report.
Of the 1,378,761 reports, 64.5% are about a safety issue only. 23.3% are about a lack of expected effectiveness, alone or with a safety issue. 12.2% are about a defect of a product or a package.
The site shows no text of a report, no lot number and no detail of a reporter. See how the site counts reports.
What a report is not
It’s also important to recognize the information in the database is as reported to the FDA’s CVM, and the agency has not necessarily determined if the product(s) in question was/were the actual cause of the events reported.
FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices
A report does not show that a drug caused a sign. FDA says this about the data:
When looking at the results, be aware that there is no certainty that the reported drug or device caused the adverse event.
The adverse event may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources.
FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices
A count of reports is not a rate. FDA says this about the data:
In addition, it is important to remember that AERs represent a small percentage of total usage numbers of a product.
Commonly used products may have a higher number of reported adverse events due to the higher total number of animals being given the product.
FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices
A count of reports is not a basis to compare drugs. FDA says this about the data:
An API dataset query result cannot be used to estimate the risk associated with the product or compare one drug or device product with another.
FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices
What FDA does with the reports
The primary purpose for maintaining the CVM AER data is to provide an early warning or signaling system to CVM for adverse events not detected during pre-market testing of FDA-approved animal drugs, detection of product manufacturing-related problems, or detection of a problem occurring because of inappropriate or incorrect use of a drug or device used in animals.
FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices
The FDA page lists the factors that FDA reviewers consider. They include the dose, the time between the drug and the signs, other drugs, and the medical history of the animal.
This site only counts the reports. It does none of this review.