FOI Request for explanation of deletion of paragraph from VMD documents
Published 19 August 2025
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Request ATI1065
It appears that sometime between 2021 and 2024, the paragraph shown below was deleted from VMD documents.
I would like to know why this was deleted, who authorised the removal and a copy of the original documents please.
“Of the 89 dogs enrolled in the 6 month open label EU continuation study without a placebo group, three dogs, aged 13, 15 and 16 years were diagnosed with Leydig cell tumors; 1 dog had a fractured coronoid process and another dog had a supracondylar fracture and there were two dogs with mild or moderate proprioceptive deficits not considered to be related to osteoarthritis. The causality for these events was not determined.”
Our reply
The VMD can confirm that the cited wording has never appeared in documents produced by the VMD or in the product literature for Librela in the UK.