FOI release

FOI2026/00481 - Accidental exposure and adverse events linked to Librela

Published 10 June 2026

1. Your request

Information regarding accidental exposure and adverse events linked to Librela (bedinvetmab).

The information requested is as follows:

1.  The MHRA’s FOI response indicates no records exist of accidental exposure to Librela. Please provide a clear explanation for this, particularly in light of the known lethality and species-specific risk of the product.

2.  Provide the exact number of accidental exposure cases, both in veterinary clinics and in home settings, not merely rates per 10,000 treated animals. If such numbers are not recorded, please explain why the VMD does not hold this critical safety data.

3.  Explain why the VMD considered it inappropriate to notify the MHRA about accidental exposures of this high-risk biologic, despite its novel mechanism and demonstrated lethality.

4.  Confirm whether clinicians treating affected individuals were provided with all relevant safety and regulatory information, including:
     *   The full drug datasheet
     *   EU CVMP assessment reports
     *   Necropsy reports from laboratory trials
     *   RPOA data
     *   Updated adverse event records, including deaths not included in the datasheet at the time
     *   Tanezumab trial data and information on refusal of continuation of trials

5.  Confirm whether the VMD advised the MHRA that affected individuals would require long-term monitoring, given the potential for delayed or wide-ranging adverse events.

2. Our reply

There are 58 cases of accidental human exposure to Librela. Two of these cases specified the location of the incident: one occurred in a home environment, and one occurred in a car. No other cases specified the location. 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 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.

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.

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.

The latest results of our in-depth assessment of selected adverse events for Librela solution for dogs are published on GOV.UK (In-depth analysis of the safety of Librela) and include our most recent assessment of human exposure to Librela.