Here’s a clear summary of the adverse drug reaction reporting system for veterinary medications:
Key Facts:
– Veterinarians are NOT required any federal or state law to report adverse drug reactions
– Only drug manufacturers are legally required to report adverse events to the FDA
– Manufacturers can only report what they know about
– Drug companies are responsible for analyzing their own adverse event data and determining what constitutes an “increased frequency” of problems
Best Practices for Pet Owners:
1. Report adverse reactions to BOTH:
– The drug manufacturer (these calls are typically recorded)
– The FDA directly through their electronic Safety Reporting Portal
Why Report to Both?
– Manufacturer calls create a recorded record of your report
– Direct FDA reports ensure the information is documented independently
– Dual reporting helps build a more complete safety picture
– Creates independent data that can verify or challenge manufacturer analyses
The Current System’s Weakness:
Drug companies essentially self-police their adverse events :
– Reviewing their own reports
– Analyzing their own data
– Interpreting their own results
– Deciding what constitutes a significant increase
– Writing their own summary reports
This self-policing system companies with a financial stake in the outcomes highlights why independent reporting pet owners and veterinarians, though voluntary, is crucial for pet safety.
Where to Report:
- Food and Drug Administration (FDA):
– Download the form here:FDA_1932a-Dynamic-9-2023-2.pdf - Or from FDA Download
– Use Form FDA 1932a for veterinary adverse events
– Include as much detail as possible about the incident
Note: You must download (as described below) and save the blank form to your computer BEFORE filling out the form. DO NOT OPEN THE FORM IN YOUR BROWSER.
1. Right-click the 1932a electronic form link above.
2. Click your browser’s Save option. On most browsers, this is the Save Link As option, but on other browsers this may be Save Target As or Download Linked File and save the file to your computer.
3. Open the file.
4. Complete the fillable for
5. Save the completed version to your computer.
6. Email the completed form to CVM1932a@fda.hhs.gov.
- Your Veterinarian:
– Inform your vet about any adverse reactions
– Ask them to document the incident in your pet’s medical record
– Request that they report the event to the drug manufacturer and the FDA if you haven’t already - Drug Manufacturer (Elanco):
– Contact Elanco directly to report adverse events
What to Include in Your Report:
– Pet’s species, breed, age, and weight
– Dose of Zorbium administered if known
– Reason for administration
– Date and time of administration
– Detailed description of adverse effects
– Any other medications your pet was taking
– Outcome (recovery, ongoing issues, death)
Why Reporting Matters
Your report can:
– Help identify patterns of adverse reactions
– Contribute to potential changes in drug labeling or usage guidelines
– Assist in improving pet safety
– Support ongoing research into Zorbium’s effects
We document and post FDA’s reports quarterly. The FDA is 6 to 9 months behind in reporting, however.
Remember: Reporting an adverse event doesn’t automatically mean the drug caused the reaction, but it helps create a more complete safety profile for Zorbium.
Additional Resources:
Should you decide to file a complaint against the veterinarian this link will point you in the direction for your state:
American Association of Veterinary State Boards
In New York, complaints are filed with the Department of Education