5638 events were reported spontaneously, mainly by the marketing authorisation holder (61%), with the remainder largely reported by veterinary surgeons.
Of these, 5512 were reports of adverse reactions in animals: 829 concerning suspected lack of efficacy, 4638 concerning safety. The majority of reports concerned dogs (2927), cats (1426) and cattle (386).
In dogs, medicines for the control of epilepsy were most often suspected of not having performed as expected (80 reports) whilst vaccines were most commonly reported as having failed to work (71). However, the VMD points out that in many cases, vaccination failure was attributable to other causes (such as incomplete vaccination schedule).
In cats, flea spot-on products were most likely to be reported as not having worked (21). However, there are many reasons why owners may continue to see live fleas on their animal which are unrelated to product efficacy (such as reinfestation from the environment).
Notably, the majority of efficacy reports in horses (12/19) related to euthanasia products, which the report says should serve as a reminder that alternative means of euthanasia should always be available in case the chosen method does not proceed as planned.
Of the safety reports, 59.6% involved dogs, 31% cats, 4.9% horses and 3.9% rabbits. The majority concerned vaccines (1360 reports, most commonly general signs or symptoms, such as lethargy or pyrexia), parasiticides (472 reports, most commonly lethargy, emesis, inflammation/pruritus, depending on method of administration) and inflammation control (412 cases, most commonly emesis, renal insufficiency and diarrhoea, depending on the drug type).
There were 124 reports of adverse events in humans. Of those involving veterinary professionals (about a quarter):
The VMD says that reports of needle stick injuries involving vaccines with a mineral oil adjuvant are of particular concern, because they often fail to show that the injured party has received prompt and correct treatment, either because they are themselves unaware of the necessity for swift intervention, or because they do not take the product package information leaflet with them when seeking medical treatment.
Similarly, the VMD says that incidents involving injectable tilmicosin seem to be often dismissed as just a scratch, and that if you use these products, you should make sure you are fully aware of the warnings contained in the product leaflets.
To read the full report, visit: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/608968/PhV_Annual_Review_2015_v7.pdf
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