IMPORTANT: data discrepancies between reports submitted to Zoetis vs. final reports to agencies
In the interest of data integrity we encourage everyone to report directly to your local and/or national regulatory agency(ies) in addition to reporting seperately to Zoetis. Maintain copies of all submissions, to whom, when and by what means (ie: email, website, etc.)
"Newly published research reveals a deeply concerning issue for animal welfare: important discrepancies between Librela’s adverse event reports submitted by attending veterinarians and the final reports filed by Zoetis.
Seemingly driven by their baseless accusations of adverse event “over-reporting” by veterinary professionals (see comment), Zoetis has been downgrading the severity of reports submitted by veterinary specialists – frequently reclassifying serious events as "not serious" and, in cases where the appropriate dose was administered by veterinarians, reporting them as "overdoses."
Please read our open access paper and consider the implications of our findings for animal health and the integrity of the veterinary pharmacovigilance process: n a https://doi.org/10.3389/fvets.2025.1581490 ".
- Dr. Michael Farrell, May 16, 2025
Reporting Adverse Events in your Country
United Kingdom
PLEASE NOTE:
VMD has temporarily disabled their website reporting form pending review of recent legal changes. The website will be updated when the review is finalized.
Set forth by the Veterinary Medicines Regulations 2013 (VMR 2013),("Guideline III Adverse Event Reporting", updated on Dec 16, 2024), onus is now on the Marketing Authorization Holder (MAH) to record and report adverse events associated with their veterinary medicinal products (VMPs) for which Marketing Authorizations (MAs) are held and defined in the VMR 2013 (as amended) Schedule 1 Part 8 paragraph 57-59.
The MAH (in this case: Zoetis) should report all adverse events occurring worldwide for their VMPs which are authorized in the UK, or the equivalent products authorized elsewhere, to the VMD within 30 calendar days of being made aware of them.
What this means for you:
You cannot currently report adverse reactions directly to VMD, you are now required to report directly to Zoetis. Zoetis must then forward your report to VMD within 30 days. To report adverse reactions to Zoetis, you can:
- call 0345 300 8034
- email customersupportuk@zoetis.com
If you have questions regarding pharmacovigilance, you can e-mail adverse.events@vmd.gov.uk
Medicine Regulator:
VMD Online Adverse Reaction Reporting: https://www.gov.uk/report-veterinary-medicine-problem/animal-reacts-medicine
VMD Adverse Event Reporting Form download: https://www.vmd.defra.gov.uk/word/animal.doc
Email: adverse.events@vmd.gov.uk
Phone: 01932 336911
Zoetis UK https://www2.zoetis.co.uk/contact-us/
Email: customersupportuk@zoetis.com
Phone: 0345 300 8034
European Union
Medicine Regulator:
HMA National Contacts list drop-down: https://www.hma.eu/veterinary-medicines/national-contacts.html
Zoetis' Choose Your Region tool: https://www.zoetis.com/customer-care
Australia
Medicine Regulator:
APVMA Adverse Experience Reporting Program: https://www.apvma.gov.au/regulation/adverse-experience-reporting-program
APVMA Adverse Experience Reporting Form:https://portal.apvma.gov.au/aerpexternal/welcome.htm
Email: enquiries@apvma.gov.au
Phone: 61 2 6770 2300
Zoetis Australia: https://www2.zoetis.com.au/contact-us
Email: productsupport.au@zoetis.com
Phone: 1800 814 883
New Zealand
Medicine Regulator:
NZ Adverse Event Reporting Programme: https://www.mpi.govt.nz/dmsdocument/20294-Adverse-Event-Reporting-Programme-for-Veterinary-Medicines
NZ Adverse Event Report Form download: https://www.mpi.govt.nz/dmsdocument/2842-acvm-25-adverse-event-report-veterinary-medicines
Email: ACVM-AdverseEvents@mpi.govt.nz
Phone: 04 894 2550
Zoetis New Zealand: https://www2.zoetis.co.nz/contact-us
Email: nzcontactus@zoetis.com
Phone: 0800 ZOETIS (963 847)
Canada
Medicine Regulator:
Heath Canada Online Adverse Reaction Reporting: https://www.canada.ca/en/health-canada/services/drugs-health-products/veterinary-drugs/adverse-drug-reactions-adrs.html
Health Canada Adverse Event Reporting Form: https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/hpfb-dgpsa/pdf/vet/adverse-drug-reactions-adrs-form-eng.pdf
Email: pv-vet@hc-sc.gc.ca
Phone: 1-877-838-7322
Zoetis Canada: https://www2.zoetis.ca/contact-us/
Zoetis Canada Online Adverse Event Form: https://www.tfaforms.com/4833498
Email: productsupport@zoetis.com
Phone: 800-461-0917
United States
Medicine Regulator:
US FDA CVM—How to Report: https://www.fda.gov/animal-veterinary/report-problem/how-report-animal-drug-and-device-side-effects-and-product-problems
FDA Form 1932a—Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report Form download: https://www.fda.gov/media/125072/download?attachment
complete as much of this form as possible, save, and send to CVM1932a@fda.hhs.gov
Email: AskCVM@fda.hhs.gov
Phone: 1-888-FDA-VETS (1-888-332-8387)
Zoetis US: https://www.zoetisus.com/product-support/vmips/
Zoetis US VMIPS Online Report: https://www.zoetisus.com/product-support/vmips/contact-vmips
Email: supportUS@zoetis.com
Phone: 1-888-963-8471 Option 2
Other
Zoetis (Scroll down to) Choose Your Region tool: https://www.zoetis.com/customer-care