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This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.

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This publication is available at https://www.gov.uk/government/publications/veterinary-medicines-pharmacovigilance-annual-review-2019-summary/veterinary-pharmacovigilance-in-the-uk-annual-review-2019-a-summary-of-veterinary-adverse-events

Pet owners, farmers, animal carers, vets and anyone else interested in animal welfare should read this review. It gives information about the reports of side effects we received during the year. These reports were usually about animals, but sometimes people had a side effect after giving a medicine to an animal, or after accidentally touching or taking an animal medicine.

The annex to this review lists the changes made to medicine information leaflets during the year.

During 2019, we improved 55 of the medicine information leaflets included with animal medicines. The changes made were based on adverse event reports received. They ensured that the benefits of using these medicines continued to outweigh any risks. They also made users better informed about the medicines they are using.

The VMD received 7,118 adverse event reports during 2019, a 0.6% decrease from the previous year. Compare this number with the millions of doses of different types of veterinary medicines used during that year.

The VMD would like to thank owners and veterinary professionals for continuing to report adverse events as without these reports, this valuable work would not be possible.

Detailed information about the reports received can be accessed through VMD’s adverse events dashboard.

Veterinary pharmacovigilance is the monitoring of all adverse event (AE) reports, both adverse reactions and lack of expected efficacy (LEE), for emerging patterns of undesirable effects, following the use of veterinary medicines.

Without the information submitted by reporters, we would not be able to continually make users better informed about the medicines they are using.

Within the UK, vets, animal owners and other people who work with animals, administer many millions of doses of different types of veterinary medicine to animals every year. In a small number of cases, an AE occurs. This may occur during, or sometime after, the use of a medicine.

The reports described in this review are those received after everyday use of veterinary products in the United Kingdom, by animal owners, vet practices and farm workers; this review does not include reports associated with scientific studies.

During 2019, VMD received and assessed 7,118 adverse event reports. This was a slight decrease on the previous year, compared to a 6.5% increase from 2017 to 2018.

Acting on the adverse event information received; the product information leaflet enclosed with medicines was improved for 55 products.

Most of the reports received described events that occurred in animals during or after the use of authorised veterinary or human medicines. Many reports involved the use of multiple products, some of which may not have been authorised medicines.

Some reports described reactions experienced by humans exposed to products used to treat animals. Others involved the detection of the residues of veterinary medicines in a food product intended for human consumption, usually milk, before it entered the food chain.

This Summary provides an overview of the adverse events received in 2019, and a list of the product information leaflet changes (See Annex).

The overall number of adverse event reports received in 2019 decreased slightly compared to 2018

A large increase in the number of all reports involving horses was offset by a large decrease in those involving sheep

The number of lack of expected efficacy (LEE) reports increased for all species, except sheep

In 2019, the number of LEEs reported in rabbits increased again, as they had done in the previous year, but the increase was not as marked. Almost all reports in these years were associated with vaccines for myxomatosis and/or rabbit haemorrhagic disease (RHD).

For horses, there were a similar number of LEE reports involving the use of euthanasia products compared to 2018. However, there was also a group of reports involving Equine flu vaccines in the first quarter of the year following an equine flu outbreak that occurred early in the year.

Many of the cases were linked, having originated from horses in a small number of yards. In most of these cases, there was insufficient vaccination history provided to determine the role of the vaccine involved.

The number of safety reports for both cats and dogs were almost the same as in 2018. There were large increases for Horses and Rabbits, and large decreases for Cattle and Sheep.

Over 50% of the products reported in horse safety cases were vaccines and most of these were flu vaccines, following on from the equine flu outbreak early in the year.

Reports involving the use of products with neurological indications were also quite common (almost 20% of products), with treatments for equine Cushing’s disease, sedatives and painkillers reported most.

69% of products reported in rabbit safety reports were vaccines against myxomatosis and rabbit haemorrhagic disease. Other types of product were, in decreasing order of prevalence, injected general anaesthetics, pain killers (predominantly buprenorphine), and sedatives (mostly medetomidine).

42% of products reported in cat safety reports were inactivated viral vaccines. All classes of anti-parasiticides were represented in safety reports, with endectocides mentioned most often followed closely by ectoparasiticides, with anthelmintics and anti-protozoal products reported least often.

Products associated with thyroid therapy were also reported, with anti-thyroid preparations reports being 7-fold higher than systemic cortico-steroid preparations.

Vaccines to control infections by severe, life-threatening diseases present in the UK dog population, recommended by the British Small Animals Veterinary Association (BSAVA), were most often reported in this species.

Products for treating or preventing infestation by internal or external parasites were reported. External parasiticides were reported most often, with newer products that act systemically being reported more often than older ones that are applied to the dog’s skin. This may reflect a change in product usage rather than a change in risk.

This is to be expected as non-authorised products should only be used where a suitable authorised product is not available and VMD is only responsible for monitoring adverse events involving authorised veterinary medicines.

Vets are required to use veterinary medicines authorised in the UK to treat animals, unless there is no suitable medicine available. Using their clinical judgement, they can decide to use a:

In 2019 96.2% of the products mentioned in animal adverse event reports were UK authorised veterinary medicines.

Of the remaining 3.8% of products:

Immunological products were the veterinary medicines most often associated with animal adverse event reports.

Explore the data using our interactive data dashboard.

The following tables list the changes made to product literature resulting from the assessment of Adverse Event report information. Without the information submitted by reporters, we would not be able to continually make users better informed about the medicines they are using, and reduce some of the risks associated with the use of those medicines.

We thank all reporters for their continuing support in providing us with the essential information we need to monitor medicine safety.

These tables lists all pharmacovigilance-related regulatory actions taken during 2019. Information received prior to 2019 will have contributed to the evidence leading to the initiation of these actions. These tables show the changes made to section 4.6 of the Summary of Product Characteristics. Equivalent changes were also made to the Product Information Leaflet that is enclosed with each medicine.

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