Veterinary Pharmacovigilance Clinical Signs Reported In Adverse Reaction Reports

Essential Information for Understanding this Listing

These listings contain all suspected adverse drug reactions (side effects) that have been reported to the VMD for a particular drug during a particular year. It includes all reports received from veterinary healthcare professionals, members of the public and pharmaceutical companies.

Conclusions on the safety and risks of veterinary medicines cannot be made on this data.

For comprehensive information about the risks of particular products, you should refer to the summary of product characteristics . If you are concerned about a product, please contact your vet or SQP.

When using these lists, you should remember that:

  • The likelihood of experiencing an adverse drug reaction when taking a product cannot be estimated from this data. This is because we have limited information about how many animals have been administered the product without experiencing a reaction.
  • The existence of an adverse drug reaction report does not necessarily mean that the product has caused the reaction. Reporters are asked to submit adverse event reports even if they only have a suspicion that the product may have caused the signs seen.
  • Sometimes clinical signs are due the condition being treated, rather than being caused by the product.
  • Recorded deaths may not be product related. Sometimes animals are put to sleep for financial reasons. In other cases a medicine may not have worked as well as expected resulting in death or a medicine may have been used incorrectly and cannot be expected to work well.
  • Many factors must be considered when assessing whether a product has caused a reported adverse drug reaction. When monitoring the safety of medicines, VMD staff and vets carry out careful analysis of these factors.
  • It is not possible to compare the safety of different medicines by comparing the numbers presented in these lists.Reporting rates can be influenced by many factors.

Benefit versus risk

Any product can cause a reaction, however most animals are administered products without suffering any serious side effects. For a product to remain authorised, the benefits of administering that product will be greater than the risk of suffering reactions.

Monitoring product safety

Information collected through adverse event reporting is a vital tool in helping the VMD monitor product safety. Adverse event reports are evaluated, together with additional evidence such as worldwide literature, in order to identify previously unidentified hazards or side effects. The VMD will take action where necessary to ensure the product is used in a way that minimises risk, for example, updating warnings, precautions or indications on product literature. In rare cases, if risk outweighs the benefit, the product will be removed from the market.

Use of this data

If you wish to copy or circulate the information contained within this list, please ensure that a copy of these guidelines is also provided.