FOI release

FOI ATI1108 - Case Safety Reports

Published 19 November 2025

ATI1108 Request

Request the original, primary-source Individual Case Safety Reports (ICSRs) for the 26 specific cases. These are cases that were submitted directly to the VMD by veterinarians, animal owners, or other primary reporters concerning the veterinary medicinal product Librela (bedinvetmab).

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.

An Excel line listing containing the information you have requested has been attached.

All reports previously submitted to the VMD that the Marketing Authorisation Holder (MAH) were not aware of are anonymised and electronically submitted to the MAH via electronic VICH XML format. The previous VMD online reporting form contained fields that were not in the VICH XML electronic transmission format, further details are provided below, where possible we have selected fields that would have been submitted to the MAH (and therefore the MAH would have received this information).

Fields provided in the Excel spreadsheet:

• The full, unaltered narrative text and description of the adverse event exactly as provided by the original reporter.
  • This is the full text provided by the reporter to the VMD from the previous VMD online reporting form field ‘Description of reaction’. Any confidential, offensive, or information not clinically relevant to the individual case report is not transmitted to the MAH but is retained in the document records of the case.
  • The full narrative text provided by the reporter does not contain all details, as these details would have been inputted in other fields e.g. reaction start date, therefore the VMD will write a narrative of all clinically relevant details provided in a chronological order, including the reaction details stated by the reporter. See Guideline III Adverse event reporting - GOV.UK for further details on what the full written narrative can contain.
• Sender type
  • Sender type is not a field in the VICH report format, we have therefore selected primary reporter category as the best fit for this.
  • The VICH options for primary reporter category are: veterinarian, animal owner, physician, patient, other health care professional, unknown, or other.
• Seriousness classification
  • This is based on VICH definition of a serious adverse event, which VICH GL24 states as: “any adverse event which results in death, is life-threatening, results in persistent or significant disability/incapacity, or a congenital anomaly or birth defect. For animals managed as a group only an increased incidence of serious adverse events as defined above exceeding the rates normally expected in that particular group is considered a serious adverse event.”
  • The classification is not based on the seriousness as defined by the reporter.
  • As stated previously, all adverse events are included in our pharmacovigilance activities, regardless of seriousness classification. As per The Veterinary Medicines Regulations 2013 (as amended) which came into effect on 17th May 2024, MAHs must submit all adverse events, regardless of seriousness classification, to the VMD within 30 days of awareness.
• Outcome
  • We have selected the VICH field ‘Outcome to date’.
  • The options for this field are: ongoing, recovered, recovered with sequela, died, euthanised, unknown.
  • We have provided the outcome to date that was selected at the time of reporting by the reporter. This may not always reflect the final outcome, for example if the outcome changed after the date the report was submitted, unless the VMD received this information to be able to change the adverse event report accordingly.
  • Some PV database systems have an additional outcome field which is auto-filled by the system based on the information inputted into the case, this is not always transmitted and does not always reflect the VICH categories.
  • Some PV database systems will use the wording ‘remains under treatment’ instead of ‘ongoing’, these are different ways of stating the same outcome. ‘Remains under treatment’ does not refer to a continuation of the Librela, and is inputted even if the animal is not receiving treatment for the adverse event.
  • The previous VMD online adverse event reporting form had the field ‘number of animals not yet recovered’ which was mapped to the VICH category ‘Ongoing’.
  • For awareness, the previous VMD online reporting form only had one field for an outcome of either death or euthanasia, therefore if this information was not provided in the additional text by the reporter, it was not possible to definitively select the correct option. To err on the side of caution, death was selected in these scenarios.
• Date the report was received
  • In the Excel this is the date the report was received to the VMD from the reporter.

In addition, you requested diagnosis, there is no VICH or previous VMD online reporting form field for this, however the previous VMD online reporting form did have a question titled ‘reason for use?’. This was not mandatory and would not have been completed by all reporters, but where this field was completed, we have added this into the Excel. In some adverse event reports, the diagnosis or reason for use was inputted into the narrative details provided by the reporter, so please check both fields. This not a VICH XML format field so would not be electronically transmitted. If you are referring to the adverse event diagnosis, again this is not a VICH XML format field nor was it a question in the VMD online reporting form, however this information is sometimes added by the reporters in the “Description of reaction” (included in the Excel).

ATI1108 excel attachment