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
Adverse effects, or adverse events as they are more widely described in veterinary pharmacovigilance, are observations that are unfavourable and unintended that happen after giving a medicine to an animal or after an animal or human are exposed to a medicine. Adverse events might include an unexpected side effect, a medicine not working as well as expected, risk to a person handling a medicine or an environmental impact.
To find out how to report any kind of adverse event following use of an animal medicine, human medicine or unauthorised product visit: Report a problem with an animal medicine or animal exposed to human medicine - GOV.UK.
The VMD’s pharmacovigilance team continuously monitors all adverse event reports that are submitted to the VMD and reports submitted directly to the Marketing Authorisation Holder (pharmaceutical company responsible for the medicine).
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 will usually 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 on MITs can be found in our signal management guidance for pharmaceutical companies.
| Product | Notification Date | Notification (go to link for full details) |
|---|---|---|
| Solensia 7 mg/ml Solution for Injection for Cats – SPC change - GOV.UK | 01/09/2026 | Ataxia, polyuria, and polydipsia can occur very rarely (<1 animals / 10,000 animals treated, including isolated reports) following administration of the veterinary medicinal product. |
| Senvelgo 15 mg/ml Oral Solution for Cats – SPC change | 21/07/2026 | The indication has been changed to: ‘For the reduction of hyperglycaemia in cats with non-insulin-dependent diabetes mellitus’. Additional information has been added to section 3.5 ‘Special precautions for use’, particularly regarding selection of patients for treatment. The adverse events section (3.6) has also been updated, with further details provided in the footnote. |
| Phenoxypen Water Soluble Powder, 325 mg/g Powder for Use in Drinking Water for Pigs and Chickens – SPC change | 18/06/26 | Pigs have been added as a target species with the indication (Section 4.2): Treatment and metaphylaxis of infections caused by Streptococcus suis. Further information added to sections 4.9 , 4.10 , 4.11, and 5.2. Section 4.4 has been updated regarding cross-resistance. |
| Bravecto 150 mg/ml Powder and Solvent for Suspension for Injection for Dogs – SPC change - GOV.UK | 04/06/26 | Emesis and diarrhoea can occur rarely (1 to 10 animals / 10,000 animals treated) following administration. Muscle tremor, ataxia, convulsion, allergic oedema, hypersensitivity reaction and pruritus can occur very rarely (<1 animal / 10,000 animals treated, including isolated reports) following administration. Section 4.5: updated for warnings regarding accidental exposure. |
| SPC update - Librela Solution for Injection for Dogs | 26/05/26 | Section 4.6 updated that in very rare cases, joint swelling, joint pain, bone and joint disorder and soft tissue ossification have been reported. Further details are provided in the associated footnote. A special precaution for use has also been added to Section 4.5 (Special precautions for use in animals) that where a dog presents with new or increased joint swelling and/or joint pain following Librela treatment (see section 4.6), consideration should be given to perform additional diagnostics and discontinue treatment on a case-by-case basis. |
| Profender - various products - SPC change | 06/03/26 | Profender Modified-release Tablets for Small, Medium and Large Dogs: Digestive tract disorders (e.g. hypersalivation, vomiting, diarrhoea), neurological disorders (e.g. tremor, incoordination), convulsion, behavioural disorders (e.g. hyperactivity), anorexia, lethargy, recumbency and hyperthermia can occur very rarely following administration of the veterinary medicinal product. Profender Spot-on Solution for Small, Medium and Large Cats and Profender Multi-dose Spot-on Solution for Cats: Neurological disorders (ataxia, tremor), hypersalivation, vomiting, diarrhoea, application site alopecia, application site pruritus, application site inflammation, behavioural disorders (hyperactivity, anxiety, vocalisation), anorexia and lethargy can occur very rarely following administration of the veterinary medicinal product. |
| Bioestrovet Swine 0.0875 mg/ml Solution for Injection – SPC change | 06/03/26 | Section 3.3: Do not use in cases of bronchospasm or gastrointestinal dysmotility. Section 3.4: The response of sows and gilts to induction of parturition may be influenced by the physiological state at the time of treatment. Section 3.5: Updated advice to reduce the risk of anaerobic infections. Section 3.7: Updated pregnancy warning: Do not administer to pregnant animals unless the objective is to terminate the pregnancy. Section 3.8: In animals to which a progestogen is being administered, a decrease in the response of cloprostenol can be expected. |
| Librela Solution for Injection for Dogs - SPC update | 03/02/26 | Section 4.6 updated that in very rare cases, paresis, paralysis and immune-mediated polyarthritis have been reported. A special precaution for use has also been added to Section 4.5 stating that caution should be used when treating patients with the following pre-existing conditions: immune-mediated haemolytic anaemia, immune-mediated polyarthritis, immune-mediated thrombocytopenia. |
| DIVENCE IBR MARKER LIVE Lyophilisate and Solvent for Suspension for Injection (Cattle) - SPC change | 01/12/25 | Section 3.6 Adverse events now states: milk production decrease, reduced food intake and decreased activity as uncommon (1 to 10 animals/10,000 animals treated). Section 3.9 Administration routes and dosage now states: Allow the vaccine to reach a temperature of 15 °C – 25 °C before administration. |
| Ataxxa Spot-on Solution for Dogs– SPC change | 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. |
Other pharmacovigilance updates
Other pharmacovigilance updates from the VMD published in the last 12 months.
| Product | Notification Date | Summary |
|---|---|---|
| Topical hormone treatments: pet owners warned of risks to pets from accidental exposure - GOV.UK | 11/06/2026 | Press release raising awareness of the risks to pets when exposed accidentally to topical human hormone replacement treatments |
| Regulator completes in-depth assessment of osteoarthritis pain relief injections for dogs - GOV.UK | 16/02/2026 | Statement from VMD’s Director of Authorisations on result of in-depth assessment of selected adverse events for ‘Librela Solution for Injection for Dogs’ |
| In-depth assessment of selected adverse events for ‘Librela Solution for Injection for Dogs’ - GOV.UK | 16/02/2026 | Results of in-depth assessment of reports of death, arthritis and human exposure following administration of Librela in dogs in the United Kingdom |
| Veterinary medicines regulator updates how it calculates adverse event incidence rates - GOV.UK | 01/12/2025 | News item explaining how VMD calculates adverse incidence rates |
Additional information
To receive updates 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 Monitoring the safety of animal medicines.
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, 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.
Contact
If you have any questions regarding pharmacovigilance you can you can contact us at Contact VMD - GOV.UK.