Urgent and clinically significant safety updates for veterinary medicines
Urgent and clinically significant safety updates arising from pharmacovigilance data, including reported adverse events, for veterinary medicines authorised in the UK.
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 should report this to the Marketing Authorisation Holder (MAH).
The MAH for a product can be found on the product leaflet or by searching for the product on the Product Information Database.
The VMD’s pharmacovigilance team continuously monitors all adverse event reports that are submitted to the VMD and reports submitted directly to the MAH.
List of urgent and/or clinically significant safety updates
Urgent and/or clinically significant safety updates published by the VMD in the last 12 months.
SPC changes listed on this page may have been made as a result of routine rather than urgent pharmacovigilance processes. They include additions of Medically Important Terms (MITs), however. 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 (go to link for full details) |
|---|---|---|
| Genta-Equine 100 mg/ml Solution for Injection for Horses – Adverse events | 18/12/24 | Increase in suspected adverse event reports following use of Genta-Equine 100 mg/ml Solution for Injection for Horses, specifically batches T-001 and V-001. |
| Librela Solution for Injection for Dogs – SPC change | 10/12/24 | Section 4.6 now states diarrhoea, emesis, ataxia, urinary incontinence, anorexia and lethargy in rare cases and seizure in very rare cases. |
| Arthramid Vet – Adverse events | 14/10/24 | Increase in social media discussion of adverse event reports including worsening of lameness and injection site reactions. |
| Senvelgo 15 mg/ml oral solution for cats – Safety update | 08/08/24 | Suspected adverse event reports concerning diabetic ketoacidosis (DKA) |
| Caninsulin 40 IU/ml Suspension for Injection – Adverse events | 19/07/2024 | Increase in adverse events relating to pain, increase in lack of efficacy reports and noted change of product formulation. |
| Neptra Ear Drops Solution for Dogs – SPC change | 27/06/2024 | Safety and efficacy of use in cats has not been evaluated so to be avoided as can be associated with neurological signs. |
| Propalin Syrup, 40 mg/ml Dogs – SPC change | 20/06/2024 | Section 4.6 now states that sympathomimetics may produce very rarely a wide range of effects, most of which mimic the results of excessive stimulation of the sympathetic nervous system. |
| Cimalgex 8 mg / 30 mg / 80 mg Chewable Tablets for Dogs – SPC change | 20/06/2024 | Section 4.6 now states polyuria and/or polydipsia may be observed on rare occasions and severe gastrointestinal and renal adverse events may be fatal. |
| 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. |
Other pharmacovigilance updates
Other pharmacovigilance updates from the VMD published in the last 12 months.
| Product | Notification Date | Summary |
|---|---|---|
| AACARB eye gel, AACOMER eye gel and PUROPTICS eye gel – MHRA update | 02/05/2024 | MHRA has provided precautionary safety advice to health professionals, patients, customers, and distributors via a Device Safety Information notice (DSI/2023/11) |
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 our Product 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 the section ‘Adverse events’ (3.6) or ‘Adverse reactions’ (4.6).
All safety updates to SPCs other than templates changes, are published on the Veterinary Practice and Supply page under the Medicine Updates section of VMD 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
Updates to this page
Published 12 December 2023Last updated 19 December 2024 + show all updates
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Updated to include Genta-Equine 100 mg/ml Solution for Injection for Horses – Adverse events.
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Updated to include changes to SPC for Librela.
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Updated to include Arthramid Vet safety update.
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Updated to include Senvelgo 15 mg/ml oral solution for cats safety update.
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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.