We wish to raise awareness of an increase in suspected adverse event reports following use of Caninsulin 40 IU/ml Suspension for Injection in the UK.
The reported adverse events most commonly include pain at the injection site and immediate pain upon injection, which may manifest as vocalisation, avoidance, or defensive behaviours. We have also noted a relative increase in lack of efficacy reports.
Adverse event reports received may include reports where more than one product was used, the product was used off-label and/or, where, on further evaluation, it is considered that there is no causal association between the product and event.
In order to comply with the British Pharmacopeia, there has been a recent change to the product formulation, with the preservative 'methyl parahydroxybenzoate' replaced by 'Metacresol 0.3 % w/v'. No changes have been made to the insulin content of the product.
If reporting an adverse event following the use of this product, the VMD requests that as much detail is provided as possible, especially the batch number and colour of the cap of the product (blue or purple tops for vials, silver or gold tops for cartridges) if this information is available.
We are working with the company responsible for the product (MSD Animal Health UK Limited) to investigate this finding and are closely monitoring reports.
You will find the Summary of Product Characteristics (SPC) for all veterinary medicinal product 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 section 4.6.
All safety updates to SPCs, including section 4.6, are published on the Veterinary Practice and Supply page under the Medicine Updates section of VMD Connect.
Reporting of adverse events
We strongly encourage anyone who is aware of an adverse event to report to the Marketing Authorisation Holder or directly to us via our online reporting form. Provide all relevant information, including the batch number.
