Librela solution for injection in dogs
Source: gov.uk (2025-01-15)

VMD response to concerns raised following media reports of serious adverse events in dogs administered Librela.

The VMD is aware of media reports and concerns, including those raised on social media, following cases of serious adverse events in dogs administered Librela[1] (#_ftn1).

Librela Solution for Injection for Dogs is an authorised injectable veterinary medicinal product containing the active substance bedinvetmab. It is indicated for the alleviation of pain associated with osteoarthritis in dogs.

Latest update

The product information for all strengths of Librela Solution for Injection for Dogs was last updated on 10 December 2024, following monitoring of pharmacovigilance data. This resulted in the addition of the following adverse events:
- In rare cases diarrhoea, emesis, ataxia, urinary incontinence, anorexia and lethargy have been reported. In very rare cases, seizure has been reported after administration of the veterinary medicinal product (Librela Solution for Injection for Dogs – SPC change - GOV.UK (https://www.gov.uk/government/news/librela-solution-for-injection-for-dogs-spc-change)).
The following adverse events were already listed in the product information:
- Injection site reaction (e.g. injection site swelling, injection site warmth), polydipsia, polyuria, hypersensitivity reaction (anaphylaxis, facial swelling, pruritus), immune-mediated haemolytic anaemia and immune-mediated thrombocytopenia.
Post authorisation monitoring

The VMD assesses the safety, quality and efficacy of veterinary medicines before and after authorisation to ensure that the benefit-risk balance remains positive. The VMD’s Pharmacovigilance team monitors all reports of suspected adverse events, both adverse reactions and lack of efficacy reports, from authorised veterinary medicinal products that are submitted to the VMD from veterinary professionals and animal owners.

The Veterinary Medicines Regulations also requires Marketing Authorisation Holders (MAHs) to monitor and report on the benefit-risk of their veterinary medicines on a continuous basis, including reporting adverse events within 30 days of awareness. All reports received by the VMD are evaluated and where appropriate, actions based on available data may be taken – for example adding additional warnings on the packaging or changing the way a product is used.

We would like to reassure veterinary professionals and dog owners that we are constantly reviewing adverse event report data to ensure that the overall benefits of each UK licensed veterinary medicine product outweighs the risk posed by their potential adverse events.

As with any veterinary medicinal product marketed in the UK, all strengths of Librela Solution for Injection for Dogs have been subject to continuous monitoring since it was first authorised in November 2020.

Safety information on product literature

No medicine is 100% risk free. The VMD does not publish specific adverse event data, however information on adverse events that have been known to occur following administration of a particular product are summarised in sections 3.6/4.6 of the Summary of Product Characteristics (SPC).

About the SPC

The SPC is a document describing the properties and the officially approved conditions of use of a medicine. The SPC and associated product information are updated as new information is available, and the latest version of an SPC can be found on our publicly available Product Information Database. (https://www.vmd.defra.gov.uk/productinformationdatabase/)

It is important for veterinary professionals to ensure that this information is reviewed prior to administering the product. A rolling 6-month list of Summary of Product Characteristic (SPC) changes for veterinary medicines can be found on the monthly medicines update page Vet practice & supply (https://www.vmdconnect.uk/medicines-update).

The SPC and associated product information for Librela Solution for Injection for Dogs (all strengths), including a list of Post Authorisation Assessments that have occurred since the products were first authorised, can be found on this database.

Reporting incidence rate

Based on Periodic Safety Update Report data that has been received across all strengths of Librela Solution for Injection for Dogs since authorisation, the incidence of adverse events in animals was 0.0015[2] (#_ftn2).

This means that according to the data the VMD has received, fewer than 15 animals have experienced a suspected adverse event for every 10,000 doses of Librela sold.

This includes reports where more than one product was used, reports when the product was used off-label, that is using a medicine in a way that is not specified on the product’s label, or reports where, on further evaluation, there were other reasons for the adverse reaction occurring.

We will continue to review data as it is received, and further data-led actions will be taken if appropriate.

Jurisdictions

There may be differences in the data that appears on product information in different jurisdictions. Each jurisdiction follows specific legislation and guidelines which regulate the safety information to be included on the veterinary medicine label and information leaflet during the authorisation process and the procedures to change this label as necessary, once the medicine is placed on the market and following analysis of post-marketing pharmacovigilance data.

The current Veterinary Medicines Regulations can be found here: The Veterinary Medicines Regulation 2013 (legislation.gov.uk) (https://www.legislation.gov.uk/uksi/2013/2033/contents). The GB legislation is similar to that of comparative European countries.

We do not comment on the regulatory decisions made by other jurisdictions or their regulatory processes.

How to report

The reporting of adverse events is critical to increasing the volume of data available for ongoing monitoring to protect animal health, public health and the environment, and we strongly encourage reporting of adverse events by both veterinary professionals and animal owners.

To report an adverse event, we would advise veterinary professionals to contact the Marketing Authorisation Holder (MAH) (pharmaceutical company) for the product. and for animal owners to contact their veterinary practice and/or the MAH for the product.

A MAH’s contact details can be found:
- within the product information that comes with a medicine
- by searching for the product on the Product information Database, (https://www.vmd.defra.gov.uk/productinformationdatabase/)
- on the MAH’s website
Further information

Important information for veterinary surgeons (https://assets.publishing.service.gov.uk/media/6787b6963f1182a1e258a26d/_2931056_Librela_News_Item_further_information.pdf) (PDF, 67.1 KB, 2 pages)

The VMD does not give individual clinical advice, as the specific treatment of an animal is best determined by the veterinary professional under whose care they fall. For advice on specific cases, general product advice or when considering off-label use, we advise veterinary professionals to contact the MAH.

The VMD cannot help with complaints or concerns regarding the conduct of veterinary surgeons, including the way an animal has been treated using veterinary medicines. These concerns should be addressed to the Royal College of Veterinary Surgeons (https://www.rcvs.org.uk/concerns/) (RCVS).

Pharmacovigilance updates are published on the gov.uk page Urgent safety updates for veterinary medicines (https://www.gov.uk/guidance/urgent-safety-updates-for-veterinary-medicines). This also includes any updates involving non-veterinary medicines used in animals. To receive these pharmacovigilance updates via email, please click on the ‘Get emails about this page’ button. In addition, changes to authorisations most relevant to vets are published monthly in the Vet Record (the official journal of the British Veterinary Association).

[1] (#_ftnref1) This includes:
- Librela 5 mg Solution for Injection for Dogs
- Librela 10 mg Solution for Injection for Dogs
- Librela 15 mg Solution for Injection for Dogs
- Librela 20 mg Solution for Injection for Dogs
- Librela 30 mg Solution for Injection for Dogs
[2] (#_ftnref2) Incidence of adverse events is rounded to 4 decimal places and is calculated by dividing the number of doses of a product sold during the period by the number of animals experiencing a suspected adverse event.