The Therapeutic Goods Administration (TGA) undertook this safety investigation in response to concerns that increased antidepressant prescribing had resulted in an increased rate of suicide in young people in Australia. The review commenced in June 2020 and concluded in December 2020.
The aims of this safety investigation were to assess:
- the strength of the current evidence for a causal association between prescribing of antidepressants and rates of youth suicide
- the international regulatory landscape with respect to use of antidepressants in children and adolescents and risk minimisation
- the current role of antidepressants in clinical practice for the treatment of psychiatric and developmental disorders in young people in Australia
- whether the current risk minimisation measures in place in Australia are adequate.
The TGA investigation considered a number of sources of information including:
- available clinical guidelines
- adverse event data
- peer-reviewed literature
- dispensing and death data
- advice from the Advisory Committee on Medicines (ACM).
The investigation found that while the increasing use of antidepressants in young people was a concern, the strength of the current evidence available was insufficient to conclude that a causal relationship existed between prescribing of antidepressants and rates of youth suicide.[embed:render:node_insert:node:935674]
Concerns about an association between antidepressant use and increased risk of suicide first emerged in the 1990s.
Product Information and Consumer Medicine Information documents for antidepressants in Australia contain warnings about the risk of worsening depression and emerging suicidality, and advise patients and caregivers to closely monitor for worsening symptoms and suicidal thoughts.
There are several different classes of medicine that fit within the umbrella term ‘antidepressant’. The majority of these are registered for use only in adults. Use of antidepressants in individuals under the age of 18 for depression is considered ‘off-label’ in Australia. Off-label prescribing is very common in paediatric populations because the clinical trials on which approved indications are based are usually conducted in adults.
In a review article published in July 2020, Whitely, Raven and Jureidini postulated that increased antidepressant use by young Australians may be contributing to the apparent rise in youth suicide. Whitely, et al., highlighted that Pharmaceutical Benefits Scheme (PBS) antidepressant dispensing to people aged less than 28 years and suicide rates in people aged less than 25 years had both increased between 2009 and 2018.
Based on the findings of this safety investigation, the TGA will:
- Liaise with the relevant professional colleges regarding the outcomes of our review and ACM advice and, in particular, the need for additional clinical guidelines for general practitioners around the management of depression and prescribing of antidepressants to children, adolescents and young people. Letters have already been sent from the TGA to the Royal Australian College of General Practitioners, the Royal College of Physicians and the Royal Australian and New Zealand College of Psychiatrists, to advise them of the ACM advice and request that these bodies work collaboratively towards providing additional guidance for pharmacological management of depression in young people.
- Explore potential analysis of linked PBS, Medicare Benefits Schedule, hospital and death data to further investigate the clinical journeys of young people prescribed antidepressants in Australia and the relationship between antidepressants and rates of youth suicide. In addition, there will be consideration of the utility of established datasets held by the Australian Bureau of Statistics and the Australian Institute of Health and Welfare. This work will commence in early 2021 subject to access to data.