Resources Medication Resource Centre Label and Off-Label Use

Label and Off-Label Use

All medications that are approved for sale in Canada have been approved by Health Canada to be used for a specific medical illness. This is called “label indication”.This means that the medication was studied and shown to be beneficial for this particular illness. 
 
Sometimes, prescribers use medications to treat illnesses and/or populations in which the medication was not originally studied.This use of the medication is called “off-label”.Off-label use of medication does not mean there is no evidence for the medications. In most cases there is research to support the use of medications in illnesses and/or populations that were not originally studied. 
 
Off-label use of medication is quite common in psychiatry. For example, the use of antipsychotics to treat behavioural issues associated with moderate-severe Alzheimer’s Disease is considered “off-label” use of antipsychotics. Another example of off-label use is the use of the antipsychotic quetiapine for insomnia or difficulties sleeping.The use of most antipsychotic medications in children and adolescents is off-label as well because the original studies for these medications were not done with children or adolescents. 

It is important to understand why your doctor is prescribing a certain medication for you and which symptoms the medication is going to address.You should discuss with your doctor the risks and benefits of the prescribed medication for your illness, age, etc. [Working with your Health Care Team

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