In the spirit of openness and transparency, the FDA’s Center for Veterinary Medicine now makes adverse event reports (AERs) related to animal drugs and devices used in animals available on openFDA.gov, a platform electronically accessible to the general public. The platform is typically used by researchers, statisticians and other academics familiar with application programming interfaces (APIs) to access large, valuable public health datasets collected by the FDA.
The AER data received by CVM and uploaded to openFDA.gov include reports associated with approved animal drugs, unapproved/compounded drugs used in animals, and devices used in animals.
CVM’s AER data include adverse events or product defect reports related to animal drugs or devices used in animals. These can include minor or major health events, but also complaints about product quality issues, lack of effectiveness, defective packaging, and other non-health-related issues. 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.
The initial dataset on openFDA.gov includes AER data from January 1, 1987 to September 30, 2018. CVM updates the information quarterly to ensure that the public has the most current information available about adverse events reported to CVM in relation to drugs and devices used in animals.
AER Report Description
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. CVM scientists use the AER data to recognize potential safety risks and make decisions about product safety, which may include changes to the label or other regulatory action.
When analyzing the AER data, CVM’s reviewers thoroughly evaluate all safety information included in the reports. The reviewers consider several factors, such as:
- The dose of the drug the animal received and how it was given (for example, by mouth or by injection into muscle).
- The time from when the animal received the drug to when it began showing signs of illness.
- If other drugs were given to the animal at or around the same time as the drug being reviewed.
- The medical history of the animal and the animal’s physical condition at the time it received the drug.
- If the animal had a pre-existing disease or condition.
- Dechallenge and rechallenge information. This is a specific medical testing protocol where the animal stops receiving the drug (the dechallenge phase) and then starts receiving it again (the rechallenge phase). In both phases, the animal is monitored for adverse events.
- Environmental and animal management information (for example, the animal’s normal living conditions—was it an indoor pet or a food-producing animal that was outside on a pasture?).
- If there was a product defect (for example, the drug’s bottle had a broken seal or the drug was off-color).
- If the drug wasn’t approved for the species it was used in or the condition it was used to treat. This is called an “extra-label” or “off label” use.
CVM supplies AER data to openFDA.gov so that the public can access information about clinical signs that have been reported for these drugs and devices used in animals. In addition to APIs, openFDA.gov provides full sets of downloadable files to a number of high-value, high priority and scalable structured datasets, including adverse events, drug or device product labeling and recall enforcement reports.
The AER data received by CVM and uploaded to openFDA.gov includes reports associated with approved animal drugs, unapproved/compounded drugs and devices used in animals.
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. When looking at the results, be aware that there is no certainty that the reported drug or device caused the adverse event. This dataset should not be the sole source of information for clinical decision-making or other assumptions about the safety or effectiveness of a product. The adverse event may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources.
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. In recent years, the FDA has undertaken efforts to increase collection of AERs. Increases in the total number of AERs is likely a result of improved reporting; however, the FDA believes that AERs are still underreported.
For more information on API datasets, see About the openFDA API.
For information on AER reporting, see How to Report Animal Drug and Device Side Effects and Product Problems.
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The information provided using this Internet page is only intended to be General Summary Information to the Public. It is not intended to take the place of either the written law or regulations. For an authoritative source, the FDA Regulations are published in the Code of Federal Regulations (CFR), and are available in book format from the Superintendent of Documents, U.S. Government Printing Office. The CFR is also available online.