FOI release

FOI - ATI1116 Reported side effects to Librela

Published 5 January 2026

ATI1116 Request

In addition to information relating to the 33 cases requested in ATI1108, also provide the same information for the additional 4 cases listed in FOI request (ATI1067).

Our reply

Data published by the VMD are not subject to independent verification and the VMD does not guarantee their accuracy. VMD databases change over time as new and follow-up information is constantly being received and reviewed. Duplicate reports may be identified where two or more cases will then require merging into one. Therefore, the information provided below relates to the adverse event reports referred to in ATI1067 and may not reflect the results of the same search if it was performed on a different date.

In ATI1067, on the date that the search was run there were 37 adverse event reports in the database that had narratives specifying the search terms ‘RPOA’, ‘rapidly progressive osteoarthritis’ or ‘progressive osteo…”.

Not all the adverse event reports that you requested in your previous ATI1108 contained one of these search terms in the narrative provided by the reporter, any adverse event reports not fulfilling the search criteria would not have been included in the figure given in ATI1067.

Therefore, of the 37 adverse event reports in ATI1067 that fulfilled the search criteria at the time the search was run, 24 adverse event reports were submitted to the VMD by the Marketing Authorisation Holder for Librela, Zoetis. The VMD does not hold the original information provided by the reporter for these adverse event reports, this would be held by Zoetis.

Of the 37 adverse event reports, 11 are adverse event reports that you had requested and received details for as part of ATI1108. There were 2 out of 37 cases that were submitted by a reporter to the VMD that were not part of ATI1108: GBR-VMDDEFRA-02467/24 and GBR-VMDDEFRA-02468/24.

We have provided details for these two adverse event reports in an Excel spreadsheet in the same format as for request ATI1108 so that you can amalgamate the two if required.

Please note that all the field details and caveats provided in the response to ATI1108 also apply to this response and spreadsheet.

Additional Librela cases spreadsheet