Change of https://www.gov.uk/guidance/urgent-safety-updates-for-veterinary-medicines
Change description : 2025-10-06 14:56:00: Table updated to include Ataxxa Spot-on Solution for Dogs– SPC change [Guidance and regulation]
Showing diff : 2025-08-28 14:43:40.089887343 +00:00..2025-10-06 13:56:20.069505073 +00:00
Urgent and clinically significant safety updates arising from pharmacovigilance data, including reported adverse events, for veterinary medicines authorised in the UK.
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 to the Marketing Authorisation Holder (MAH or pharmaceutical company).
The MAH for a UK-authorised medicine can be found on the product leaflet or by searching for the product on the Product Information Database.
To report a suspected adverse event to a human medicine or a product that you know is not an authorised veterinary medicine, please request a form from adverse.events@vmd.gov.uk, stating within your email that you are requesting the form in order to report an adverse event to a human medicine or to a product that you know is not an authorised veterinary medicinal product, as applicable.
The VMD’s pharmacovigilance team continuously monitors all adverse event reports that are submitted to the VMD and reports submitted directly to the MAH.
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) |
|---|---|---|
| Ataxxa Spot-on Solution for Dogs– SPC change - GOV.UK | 26/09/25 | Section 3.7/4.7 Use during pregnancy, lactation or lay has been updated; safety has not been established in dogs during pregnancy, lactation or in animals intended for breeding. Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects…”additionally section 3.5/4.5 for Ataxxa 2000 mg/400 mg Spot-on Solution for Dogs Over 25 kg has been updated. |
| DIVENCE PENTA lyophilisate and solvent for emulsion for injection – SPC change | 27/08/25 | Section 3.6 updated to state a temporary mild reduction in milk production, feed intake and activity may uncommonly be observed in dairy cows, mostly after the first dose. |
| Credelio 12mg and 48mg chewable tablets for cats – SPC change | 05/08/25 | Section 4.6 now states anorexia, lethargy, tachypnoea, ataxia, muscle tremor, hyperactivity and pruritus can occur very rarely as an adverse event. |
| StromEase 25 mg/ml Eye Drops, Solution for Dogs and Cats – SPC change | 15/07/25 | Section 4.6 has been amended to clarify that irritation or inflammation of the eye and/or its adnexa have been reported in very rare cases, especially blinking of the eyelids or even closure of the eye, eye redness or conjunctival oedema, particularly in dogs. |
| Zermex 100 mg/ml LA Solution for Injection for Cattle and Zermex 20 mg/ml LA Solution for Injection for Sheep – SPC change | 04/07/25 | Section 4.6 on both SPCs has been updated to include reactions that may happen on very rare occasions. |
| Further update: Genta-Equine 100 mg/ml Solution for Injection for Horses – Adverse events | 27/06/25 | The Marketing Authorisation Holder (MAH) will implement a maximum limit for histamine in the active substance used within the product. |
| Osurnia Ear Gel for Dogs – SPC change | 11/06/25 | Information relating to the occurrence of eye disorders, despite no direct ocular contact, has been removed from section 4.5 and section 4.6 (adverse reactions) has been updated. |
| SPC change - Credelio Chewable Tablets for Dogs | 29/04/25 | Section 4.6 now states Pruritus, bloody diarrhoea, urinary incontinence, inappropriate urination, polyuria and polydipsia can occur very rarely following the administration of the veterinary medicinal product. |
| Alizin 30 mg/ml Solution for Injection – SPC change - GOV.UK | 17/03/2025 | Sections 4.5 and 4.6 now state rare cases of abortion failure could lead to dystocia or uterine rupture and very rarely to fatal outcome. |
| Update: Genta-Equine 100 mg/ml Solution for Injection for Horses – Adverse events - GOV.UK | 14/03/2025 | Presence of histamine in batches T-001 and V-001. |
| Meflosyl 5% Solution for Injection SPC change | 13/01/2025 | Section 4.6 now states that in very rare cases allergic reactions (anaphylaxis) may occur after administration of the veterinary medicinal product. |
| Genta-Equine 100 mg/ml Solution for Injection for Horses – Adverse events | 18/12/2024 | Increase in suspected adverse event reports following use, specifically batches T-001 and V-001. |
| Librela Solution for Injection for Dogs – SPC change | 10/12/2024 | 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 | 14/10/2024 | 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 | 08/08/2024 | Suspected adverse event reports concerning diabetic ketoacidosis (DKA) |
Other pharmacovigilance updates from the VMD published in the last 12 months.
| Product | Notification Date | Summary |
|---|---|---|
| Solensia 7 mg/ml Solution for Injection for Cats - GOV.UK | 30/01/2025 | Response to concerns raised following media reports of serious adverse events in cats administered Solensia. |
| Librela solution for injection in dogs - GOV.UK | 15/01/2025 | Response to concerns raised following media reports of serious adverse events in dogs administered Librela. |
To receive update on this page click on the ‘Get emails about this page’ button at the end of the page.
Further guidance on what veterinary pharmacovigilance is and who is responsible can be found in the guidance documents on gov.uk.
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).
A rolling 6-month list of SPC changes for veterinary medicinal products is 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.
If you have any questions regarding pharmacovigilance you can e-mail adverse.events@vmd.gov.uk
Table updated to include Ataxxa Spot-on Solution for Dogs– SPC change
Updated to include DIVENCE PENTA lyophilisate and solvent for emulsion for injection and Credelio 12mg and 48mg chewable tablets for cats – SPC changes.
Table updated to include Zermex 100 mg/ml LA Solution for Injection for Cattle and Zermex 20 mg/ml LA Solution for Injection for Sheep - SPC change and StromEase 25 mg/ml Eye Drops, Solution for Dogs and Cats – SPC change.
Further update: Genta-Equine 100 mg/ml Solution for Injection for Horses – Adverse events added to table.
Updated to include Osurnia Ear Gel for dogs.
Added SPC change for Credelio 56 mg / 112 mg / 225 mg / 450 mg / 900 mg Chewable Tablets for Dogs.
Updated to include SPC change to Alizin 30 mg/ml Solution for Injection.
Update to adverse event information for Genta-Equine 100 mg/ml Solution for Injection for Horses.
Added Meflosyl 5% Solution for Injection SPC change.
Updated to include Genta-Equine 100 mg/ml Solution for Injection for Horses – Adverse events.
Updated to include changes to SPC for Librela.
Updated to include Arthramid Vet safety update.
Updated to include Senvelgo 15 mg/ml oral solution for cats safety update.
Prevomax 10mg/ml Solution for Injection for dogs and cats added under Urgent safety updates published by the VMD in the last 12 months.
Notification to add Solensia 7 mg/ml Solution for Injection for Cats – SPC change.
Pharmacovigilance updates section added
First published.
2025-10-06 14:56
Table updated to include Ataxxa Spot-on Solution for Dogs– SPC change
2025-08-28 15:43
Updated to include DIVENCE PENTA lyophilisate and solvent for emulsion for injection and Credelio 12mg and 48mg chewable tablets for cats – SPC changes.
2025-07-17 15:41
Table updated to include Zermex 100 mg/ml LA Solution for Injection for Cattle and Zermex 20 mg/ml LA Solution for Injection for Sheep – SPC change and StromEase 25 mg/ml Eye Drops, Solution for Dogs and Cats – SPC change.
2025-06-27 13:49
Further update: Genta-Equine 100 mg/ml Solution for Injection for Horses – Adverse events added to table.
2025-06-12 11:26
Updated to include Osurnia Ear Gel for dogs.
2025-04-29 09:44
Added SPC change for Credelio 56 mg / 112 mg / 225 mg / 450 mg / 900 mg Chewable Tablets for Dogs.
2025-03-18 10:18
Updated to include SPC change to Alizin 30 mg/ml Solution for Injection.
2025-03-14 14:38
Update to adverse event information for Genta-Equine 100 mg/ml Solution for Injection for Horses.
2025-01-16 16:01
Added Meflosyl 5% Solution for Injection SPC change.
2024-12-19 08:53
Updated to include Genta-Equine 100 mg/ml Solution for Injection for Horses – Adverse events.
2024-12-10 14:03
Updated to include changes to SPC for Librela.
2024-10-14 10:19
Updated to include Arthramid Vet safety update.
2024-08-08 16:36
Updated to include Senvelgo 15 mg/ml oral solution for cats safety update.
2024-04-12 15:48
Prevomax 10mg/ml Solution for Injection for dogs and cats added under Urgent safety updates published by the VMD in the last 12 months.
2024-03-11 09:25
Notification to add Solensia 7 mg/ml Solution for Injection for Cats – SPC change.
2023-12-19 12:30
Pharmacovigilance updates section added
2023-12-12 12:11
First published.