What should I do first if I suspect an adverse drug effect?

If it is severe, if you fear it can worsen, it you read something about a possible severe reaction in the notice, or if you are anxious or any other reason, always try to contact your doctor, or another healthcare professional. In other words, get help! In some cases you may need to contact the emergency services or go to the nearest emergency unit.
 

What else can I do?

There is a lot you can do, for yourself, and also to help other people who may take the same drug in the future. What happens needs to be communicated to the persons in charge of drug surveillance: they can analyse what has happened, see if it is due to the drug or not, and propose measures to reduce the risk of it happening to another patient. But first, these experts need to be informed that an adverse drug reaction has occurred.

new drug treatment

A group of patients volunteered to participate in a clinical trial for a new drug. The group was quite small (26 participants), no one had a serious adverse reactionnew drug treatment

When all patients have access to the drug, after marketing authorisation, one (in red) may possibly suffer from an effect not seen during the clinical trials

 

If 10 persons are enrolled in a trial and treated with a new drug, only very frequent side effects that occur in more than 1 person in 10 can be detected.

If 100 persons are enrolled in a trial and treated with a new drug, only frequent side effects that occur in more than 1 person in 100 can be detected.

If 1000 persons are enrolled in a trial and treated with a new drug, only common side effects that occur in more than 1 person in 1000 can be detected.

When 10 000 persons are treated after marketing authorisation (all patients who need treatment), then rarer reactions that happen in more than 1 person in 10 000 can be detected.

 

Often the patient will discuss the event with their doctor, nurse or pharmacist. One of them may report it to the experts in charge (“pharmacovigilance experts”).

So your first action will be to talk to your doctor, who will treat the adverse reaction accordingly. Your doctor will then decide to report it or not.

However, healthcare professionals may not always report adverse reactions, due to lack of time, or lack of awareness of the importance to do so.

Therefore, your second action could very well be to report it yourself. The new legislation invites Member States to create supports to make this possible. 

Page created: 08/11/2012
Page last updated: 07/11/2014
 
 
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