FOI release

FOI2026/00474 - Accidental human exposure to Librela and Solensia

Published 10 June 2026

1. Your request

I am writing to request information regarding accidental human exposure to the veterinary monoclonal antibody medicines Librela and Solensia.

Please provide the following information covering the period from the date each product was first authorised for use in the United Kingdom to the present date:

1. The total number of reported cases of accidental human exposure (including needle-stick injuries or accidental self-injection) associated with Librela.

2. The total number of reported cases of accidental human exposure associated with Solensia.

3. For each product, please provide a breakdown of these cases by location, specifically:
        *   exposures occurring in veterinary surgeries or other clinical settings, and
        *   exposures occurring in home settings or by pet owners.

4. For each case of human exposure recorded by the Veterinary Medicines Directorate, please state what actions were taken to ensure that clinicians treating the affected individuals were provided with appropriate safety information about the product.

5. Please confirm whether the VMD:
        *   notified or consulted with the Medicines and Healthcare products Regulatory Agency in relation to any of these human exposure cases; and
        *   provided or offered to provide safety or pharmacological information to the attending physicians responsible for treating the affected individuals.

6.  Given that the UK Summary of Product Characteristics (SPC) for these medicines contains less safety information than product documentation available in some other jurisdictions, please confirm:
     *   whether the VMD supplied additional pharmacological or safety information to clinicians treating affected individuals; and
     *   what steps were taken to ensure that attending physicians had access to all relevant safety data available internationally.

7.  Please confirm whether the marketing authorisation holder, Zoetis, was notified of the reported cases of accidental human exposure, and if so, what actions or responses were recorded.

8.  Please provide details of any internal risk assessments, reviews, or safety evaluations carried out by the VMD in relation to human exposure to Librela or Solensia.

9.  Please confirm whether the VMD has conducted any assessment of the risk associated with home administration of these medicines, particularly in relation to accidental self-injection.

10.  Please provide copies of any internal correspondence, communications, or documented discussions between the VMD and Zoetis relating to:
  *   accidental human exposure to Librela or Solensia,
  *   safety concerns relating to human exposure, and
  *   the continued allowance of home administration of these products.

If any of the requested information cannot be disclosed, please specify the relevant FOIA exemption relied upon and provide the reasons why it applies.

2. Our reply

2.1 Requests relating to suspected adverse event reports

The total number of reported cases of accidental human exposure (including needle-stick injuries or accidental self-injection) associated with Librela is 58.

The total number of reported cases of accidental human exposure associated with Solensia is 18.

Two Librela cases specified the location of the incident: one occurred in a home environment, and one occurred in a car. None of the Solensia cases specified where the incident took place. However, the reports did indicate whether the exposed individual was a veterinary professional or an owner. Therefore, we have summarised below the number of cases involving exposure in veterinary professionals, cases where owners were exposed while a veterinary professional was administering the product, and cases where owners were exposed while administering the product themselves.

For Solensia, of the 18 reported cases, 16 cases of accidental human exposure occurred in veterinary professionals (veterinary surgeons or nurses). One case reported owner exposure but did not specify who administered the product, and one case reported that the owner was administering the injection.

For Librela, of the 58 reported cases, 50 cases of accidental human exposure occurred in veterinary professionals (veterinary surgeons, veterinary nurses, or veterinary students in training). One of these cases occurred in a veterinary professional while driving, when they reached into their bag. Six cases involved owner exposure while a veterinary professional was administering the product, and one case involved the owner administering the product at home.

All of these cases were reported to the VMD by Marketing Authorisation Holder Zoetis.

2.2 Requests relating to information provided to clinicians and the MHRA

The package leaflet advises people who experience accidental exposure or adverse reactions to consult a doctor and take the medicine container, label, or package leaflet with them. This enables the clinician to see the active substance, precautionary statements, and first aid advice exactly as authorised.

More detailed product information, including the Summary of Product Characteristics (SPC) and the Public Assessment Report, is published on the VMD Product Information Database, where updates appear shortly after authorisation changes. We do not make available information already available on the internet that is relevant to international jurisdictions.

Accidental exposure to veterinary medicines, including biologics, is monitored within the VMD’s statutory pharmacovigilance system. Under the Veterinary Medicines Regulations, the VMD is responsible for adverse events in animals, people handling veterinary medicines, and the environment. The MHRA regulates human medicines under separate legislation and operates the Yellow Card Scheme, which does not apply to veterinary medicinal products. Because the regulators have distinct legal remits, reporting systems and data models, there is no mechanism or requirement for routine notification between the two agencies.

2.3 Requests relating to internal assessments

On 16 February 2026, we published an in-depth assessment of adverse event reports relating to Librela, covering death, arthritis progression, and human exposure. This sets out our findings and the evidence base for our current position in full, and we would encourage you to read this and a statement from our Director of Authorisations on this assessment:

In-depth assessment of selected adverse events for ‘Librela Solution for Injection for Dogs’ - GOV.UK

Regulator completes in-depth assessment of osteoarthritis pain relief injections for dogs - GOV.UK

2.4 Requests relating to in-home administration

Once a product is authorised, decisions about how it is used in an individual animal are a matter of professional clinical judgement for the attending veterinary surgeon on the capability of the owner to administer these, and provide pertinent safety advice.