Reporting side effects from veterinary medicines

What should I do if I or an animal in my care have side effects?

Anyone who becomes aware of a suspected side effect from a veterinary medicinal product should report it to the Danish Medicines Agency. This means veterinarians, healthcare professionals, the owner of the animal or others in contact with animals. It should also be reported if a human experiences any unintended reactions after contact with a veterinary medicinal product.

You should contact a veterinarian if there is reason to suspect that an animal has side effects. The veterinarian can assess whether the side effect means that the treatment should be changed. The veterinarian can report the side effect to the Danish Medicines Agency and provide us with additional details from the record, which will make it easier for us to establish any relationship between the reaction and the medicinal product used.

Side effects are categorised as serious or non-serious. A serious side effect is a side effect that results in death, is life-threatening or causes significant disability, reduction in production output or inability to work, or is a congenital anomaly or birth trauma, or which causes persistent or long-term symptoms in the animal treated.

It may be relevant to report environmental incidents or any maximum residue limits in foodstuffs of animal origin, where veterinary medicinal products are involved.

Veterinarians have a reporting obligation

Veterinarians are obliged to report any serious or unexpected side effects in the animals they are treating or in humans who have been in contact with the medicinal product.

Veterinarians are also obliged to report known or non-serious side effects and reactions during the first two years a new medicine is on the market. You can read more about known reactions in the summary of product characteristics of the relevant medicinal product.

What happens to reported side effects?

When the Danish Medicines Agency receives a adverse reaction report, we

• evaluate the report
• send the information about the side effect to the company responsible for the medicine
• register the report in the EU database of side effects (see EudraVigilance) so that other drug regulatory authorities can benefit from the information.

All reports for each single medicine are reviewed regularly (see safety update reports). Our evaluation may lead to changes to the summary of product characteristics and the package leaflet.

The Danish Medicines Agency can also direct the company responsible for the medicine to conduct an extraordinary study of the safety of the medicine concerned. If the side effects were caused by a production error, batches of that medicine may be withdrawn from the market. In rare cases, the medicine is taken off the market.