Category: European Union

The VMD is aware of media reports and concerns, including those raised on social media, following cases of serious adverse events in cats administered Solensia 7 mg/ml Solution for Injection for Cats.

Solensia 7 mg/ml Solution for Injection for Cats is an authorised injectable veterinary medicinal product containing the active substance frunevetmab. It is indicated for the alleviation of pain associated with osteoarthritis in cats.

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 from 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 cat owners that we are constantly reviewing adverse event report data to ensure that the overall benefits of each UK licensed veterinary medicine product, when used in accordance with its labelling, outweighs the risks posed by their potential adverse events.

As with any veterinary medicinal product marketed in the UK, Solensia has been subject to continuous monitoring since it was first authorised in February 2021.

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. 

Product information also physically  accompanies every authorised veterinary medicinal product when marketed and 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 Connect monthly medicines update page Vet practice & supply.

The SPC and associated product information for Solensia, including a list of Post Authorisation Assessments that have occurred since the products were first authorised, can be found on this database.

Following monitoring of pharmacovigilance data, the latest update to the adverse event section of the product information resulted in the addition of the adverse event anaphylaxis; (Solensia 7 mg/ml Solution for Injection for Cats – SPC change – GOV.UK).

The following adverse events were already listed in the product information: alopecia, dermatitis, pruritus, injection site reaction (e.g. pain and alopecia) and skin disorders (e.g. skin scab, skin sore).

Reporting incidence rate

Based on Periodic Safety Update Report data that has been received for Solensia since authorisation, the incidence of adverse events in animals was 0.0025.[i]

This means that according to the data the VMD has received, fewer than 3 animals have experienced a suspected adverse event for every 1000 doses of Solensia 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). The GB legislation is similar to that of comparative European countries.  

How to report

The reporting of adverse events is critical to increasing the volume of data available for ongoing monitoring in order 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 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
• on the MAH’s website

Further information

Important information for veterinary surgeons (PDF, 105 KB, 2 pages)

The VMD does not give individual clinical advice, for advice on individual cases we would 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 (RCVS).

Pharmacovigilance updates are published on gov.uk at  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).

[i] 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.