25 Feb 2026
Regulators say they remain “satisfied” with the OA treatment despite continuing demands for its withdrawal.
Allister Webb
Job Title
Image: Trsakaoe / Adobe Stock
UK medicine regulators have declared themselves satisfied that the benefits of a leading canine osteoarthritis (OA) drug outbalance its risks for most patients.
A newly published VMD assessment acknowledged the condition of some dogs appeared to rapidly worsen following treatment with Librela, but suggested any connection to the drug remained unclear.
The document, published on 16 February, followed recent changes to the published Summary of Product Characteristics (SPC) for Librela, which is manufactured by Zoetis.
The revised summary, said to have been made following monitoring of its pharmacovigilance data, added that paresis, paralysis and immune-related polyarthritis had been reported “in very rare cases”.
It also advised caution in the treatment of patients with three pre-existing conditions: immune-mediated haemolytic anaemia, immune-mediated polyarthritis and immune-mediated thrombocytopenia.
But the new assessment said data available since its authorisation showed deaths following the administration of Librela were “rare”, occurring in one to 10 animals per 10,000 treatments.
The paper said there appeared to be “a small subset” of dogs aged six or older whose condition rapidly deteriorated within 14 days of administration, but it remained “unclear whether many of these reports were product related”.
Accompanying safety information also listed known adverse events in the product information as of last month, describing them as either uncommon, affecting between one and 10 animals per 1,000 treated; rare, affecting between one and 10 animals per 10,000 treated; and very rare, affecting less than one animal per 10,000 treated.
VMD deputy chief executive Gavin Hall said the body was aware of the concerns held by some dog owners and veterinary professionals about Librela, and would continue to monitor it closely.
But he added: “Based on all available evidence and our in-depth analysis, we are satisfied that the overall benefits of Librela continue to outweigh the risks for the vast majority of dogs treated with this medicine.”
In response, a spokesperson for Zoetis said it was continuing to work “proactively and openly” with the VMD and other regulators to encourage the reporting of adverse events, and ensure vets had accurate and current information to support treatment decisions.
They added: “We remain committed to the highest standards of animal safety and to providing clear, evidence-based information for pet owners.”
But the Librela Solensia The Truth UK campaign group said its fight for the drug to be withdrawn from sale would continue, as it questioned the VMD’s approach.
It said: “It is particularly concerning that, once again, the VMD guidance appears to leave veterinarians exposed to potential blame.
“While we recognise that veterinarians have a professional duty under RCVS regulations to familiarise themselves with available drug information, we believe that clearer, more centralised information may have enabled more prudent use of these drugs, or in some cases, discouraged their use altogether.”
The new assessment was also accompanied by the reissuing of earlier guidance to vets that advised that “alternative treatments” should be considered if dogs showed limited or no response after two Librela doses.
It also said vets and clients should “discuss and agree a specific treatment programme for an individual animal” that balanced clinical needs with the potential risks.
