Veterinary Medicines Directorate
Reporting an adverse event
An adverse event is any observation in animals, whether or not considered to be product-related, that is unfavourable and unintended and that occurs after any use of a veterinary medicine, whether off-label or on-label use. This include events related to a suspected lack of expected efficacy according to approved labelling or noxious reactions in humans after being exposed to a veterinary medicine.
If anyone becomes aware of an adverse event involving a veterinary medicine they can report this either to the company, the Marketing Authorisation Holder (MAH), or directly to the VMD.
The MAH for a product can be found on the product leaflet or by searching for the product on the Product Information Database.
You can also report directly to the VMD using our online reporting form.
The VMDs pharmacovigilance team continuously monitors all adverse event reports that are submitted to the VMD and reports submitted directly to the MAH.
List of urgent safety updates
Urgent safety updates published by the VMD in the last 12 months.
SPC changes listed on this page include additions of Medically Important Terms (MITs). SPC changes involving non-MITs assessed as having a significant beneficial clinical impact may also be included. More detail can be found in our adverse event reporting guidance.
| Product | Notification Date | Problem |
|---|---|---|
| Prevomax 10 mg/ml Solution for Injection for Dogs and Cats SPC change | 11/04/2024 | Section 4.6 now states that lethargy, ataxia, convulsion, seizures, and muscle tremors can occur very rarely (<1 animal in 10,000 animals treated, including isolated reports) following administration. |
| Solensia 7 mg/ml Solution for Injection for Cats SPC change | 08/03/2024 | Section 4.6 now states that anaphylaxis can occur very rarely. This is defined as <1 animal in 10,000 animals treated, including isolated reports, following administration. It also states that in case of such reactions, appropriate symptomatic treatment should be administered. |
| Co-amoxiclav | 09/08/2023 | Anaphylaxis following intravenous co-amoxiclav administration. |
| Pergolide | 09/08/2023 | Minimising risk of human exposure during administration of pergolide to horses. |
Other pharmacovigilance updates
Other pharmacovigilance updates from the VMD published in the last 12 months.
| Product | Notification Date | Summary |
|---|---|---|
| Leptospira vaccination in dogs | updated 15/12/2023 | VMD response to concerns raised following media reports of serious adverse events in dogs given the vaccine containing four strains of Leptospira bacteria. |
Additional information
Further guidance on what veterinary pharmacovigilance is and who is responsible can be found in the guidance documents on gov.uk.
To sign up for urgent safety updates please click on the Get emails about this page button at the end of the page.
You will find the Summary of Product Characteristics (SPC) for all veterinary medicinal products authorised for marketing in the UK on ourProduct Information Database
No medicine is 100% risk free, the SPC includes information on what adverse events have been known to occur following administration of a particular product, these can be found in section 4.6.
All safety updates to SPCs, including section 4.6, are published on the Veterinary Practice and Supply page under the Medicine Updates section ofVMD Connect.
Additional updates on veterinary pharmacovigilance in the UK can also be found on the adverse events page of VMD Connect.
Contact
If you have any questions regarding pharmacovigilance you can e-mail adverse.events@vmd.gov.uk
Last updated 12 April 2024 +show all updates
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Prevomax 10mg/ml Solution for Injection for dogs and cats added under Urgent safety updates published by the VMD in the last 12 months.
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Notification to add Solensia 7 mg/ml Solution for Injection for Cats SPC change.
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Pharmacovigilance updates section added
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First published.