Report a side effect or lack of efficacy in animals

REPORTING FORM
(only available in Danish)

Report a side effect or lack of efficacy

Using this form you can report:

  • Suspected side effects in animals – both from veterinary medicines and from human medicines given to an animal.
  • Suspected side effects in humans following contact with veterinary medicines.
  • Suspected lack of efficacy of veterinary medicines.

Be aware, that you do not need to be certain that the medicine caused the events in order to report it. It is enough to suspect that there may be a correlation. However, if you are a veterinarian, you will be asked to provide your opinion of the causal association.

You can report as a veterinarian, other animal professional or as an animal owner. It is possible to report events for one or more single animals or for a larger group or herd/flock at once.

We will only contact you in case we need additional information. Unfortunately, it is not possible for us to provide specific feedback on each report, however, your report is still important to us.

See also further information in the menus below.

In case of questions or trouble with the form: Send an email [KRU1] with information regarding the events you want to report and your contact-information, or contact us by phone: +45 44 88 95 95

Q&A

Before you open the reporting form it is recommended to have the following information ready and available:

  • The package from the medicine or a picture of it
  • Information about the animal(s) – e.g. species, breed, weight, age, previous health history.
  • Information about the timing of treatments and events – e.g. when treatment started and ended, when the side effect started and ended and information on concurrent treatment with other medicines etc.
  • If you are a veterinarian, it is a good idea to have the animal’s medical records available.

In this way you will have all the necessary information ready to answer the questions in the form. See also ”how to make a good report of side effects or lack of efficacy” below.

Exact and complete information is necessary to evaluate the causal association

The form will ask you to both describe the events with your own words and also fill in a number of specific information-fields about the medicine, the timing of events etc.

It may feel excessive to fill out both, however, it is important to ensure that we both receive your recollection of events with your own words while simultaneously ensuring we have enough information for the report to be useful for further analysis.

The focus is placed on information that is important to evaluate the causal association between the suspected medicine(s) and the side effect(s). Therefore, we highly appreciate if you provide as precise information as possible about:

  • The animal(s)
  • The (veterinary) medicinal product and how it was handled and given to the animal
  • The timing of events
  • The side effect(s)
  • The medical history – including any other factors which may have affected the course of events

When reporting suspected lack of efficacy, it is particularly important to provide information on how the lack of efficacy was noted and potentially tested, and whether the medicine was stored, handled and given to the animal as recommended in the product information. It is also important to inform about any consequences of the lack of efficacy.

Example of why precise and complete information is important when reporting side effects:

After the dog Fido was treated with Medicine X he got diarrhoea and vomited.

Both information about the animal, medicine and timing of events are lacking.

 

It is especially problematic that it is not clear when Fido developed diarrhoea compared to when he received treatment with Medicine X – If the diarrhoea started immediately after the treatment started, an association would appear more likely. But maybe Fido started receiving Medicine X many weeks before he developed diarrhoea?

 

It is also not clear whether Fido is still receiving Medicine X or not, and if he is not, whether treatment ended before or after the side effects occurred? It is also not possible to evaluate whether end of treatment made the side effect improve or disappear.

 

Furthermore, it is not known from this alone whether Fido received Medicine X in the correct dosage, and which version of the brand name ”Medicine X” he received and how. It could have been an injection, an oral tablet or maybe it was the eye-drop version of Medicine X?

 

On 1 January, in the evening, the dog Fido (1-year-old labrador, 30 kg, neutered male) received 1 tablet of Medicine X (Strength 1 mg) to treat arthritis in his back for the first time. From then on, he received 1 tablet morning and evening up until January 5th. Fido was given the medicine by mouth with a small amount of food.

 

On January 3rd, after 2 days of treatment, Fido suddenly vomited up his breakfast a few hours after eating. In the afternoon on the same day, Fido had diarrhoea. The diarrhoea was watery and Fido had to go outside many time at all hours of the day. He was also lethargic and not himself, although he did not vomit again.

 

After consultation of the attending vet by phone, the owner was recommended to stop giving Medicine X, and no more was given from midday on January 5. The next day (Jan 6th) the diarrhoea had already improved, and by 7 January Fido’s stool and behaviour was completely back to normal.

 

Fido has previouslt been treated with Medicine Y and is now treated with Medicine Z without any side effects. Fido is not generally prone to diarrhoea or vomiting and he did not receive any other medicine while he was treated with Medicine X.

 

However, on his usual walk on 2 January, Fido did eat something unknown he had found in a bush beside the path.

There is a lot more useful information in this version.

 

Now we know that Fido received a correct dose, and which exact product he was treated with.

 

We know that Fido’s symptoms started shortly after treatment start and improved when the treatment was stopped.

 

We also know that Fido did not receive any other medication at the same time, which might have caused the diarrhoea, and that the disorder that Medicine X was supposed to treat is not usually associated with diarrhoea and vomiting. It is also stated that Fido doesn’t have diarrhoea often – Also not when treated with other medicines before and after Medicine X.

 

All of this is indicative of an association of the diarrhoea and vomiting to treatment with Medicine X.

 

However, we also receive important information that Fido ate something unknown that he found outside, shortly before the diarrhoea and vomiting occurred. Therefore, this cannot be ruled out as an alternative cause of his symptoms.

 

Example of reporting lack of efficacy – in the example, Medicine XX is a medicine to treat intestinal worms:

The cat Bella still has worms after treatment with Medicine XX

Information about what type of worms Bella had is missing. Was it even a type of worm that Medicine XX can treat?

 

Did Bella receive the correct dose and was the medicine given correctly?

 

How long time passed from treatment with Medicine XX until Bella had worms again? Could it be a new infection?

 

Is it the same type of worms she has this time?

 

How does the reporter know that Bella had worms before and how does he/she know that she has them again now?

 

The cat Bella, (2 years old, domestic shorthair, neutered female) was treated with Medicine XX on 1 January because she had roundworm. The owner noticed she had worm because she threw up worms one day.

 

A stool sample collected one week prior to treatment had shown that Bella was infected with roundworm of the species T. Cati. The animal owner administered 1,5 tablet of Medicine XX (Strength 1mg) to Bella on January 1st by crushing the tablets and mix the powder into Bellas food. The owner is not completely sure if Bella ate all the food, but she ate most of it at least.

 

One month later, on February 1st, Bella again vomited up similar looking worms, but new stool samples have not been analysed by the attending veterinarian.

 

Bella is a strict indoor cat, and there are no other pets in the home.

There is much more useful information in this version.

 

Now we know that the report concerns potential lack of efficacy toward one of the common roundworms seen in cats, T. Cati, and that the diagnosis prior to treatment was made using correct methods.

We are also told that suspected lack of efficacy is seen 1 month after treatment, although this time the diagnosis is less certain, as there was no stool sample.

 

It is also clear that Bella may have been underdosed, in case she did not eat all the food with the crushed tablets. Furthermore, the tablets were not handled correctly, since Medicine XX is not supposed to be crushed prior to administration according to the product information.

 

It is also stated that Bella is a strict indoor cat and that there are no other pets in the household, which lowers the risk of this being a new infection significantly.