FOI2026/00483 - Accidental exposure and adverse events linked to Solensia
Published 10 June 2026
© Crown copyright 2026
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/vmd-foieir-requests-march-2026/foi202600483-accidental-exposure-and-adverse-events-linked-to-solensia
1. Your request
Information regarding accidental exposure and adverse events linked to Solensia (frunevetmab).
The information requested is as follows:
1. 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.
2. 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.
3. 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
4. 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 18 cases of accidental human exposure to Solensia. None of the 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, 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.
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.