The Therapeutic Goods Administration (TGA) has continued its safety investigation of antidepressant use and the risk of suicide in young people.
The TGA published the initial safety review report and a related safety alert in December 2020. An updated report was published in April 2021.
The review found that, while the increasing use of antidepressants in young people was a concern, the current available evidence was not sufficient to conclude that prescribing of antidepressants was causing an increase in the rate of youth suicide.
The Department of Health commissioned NPS MedicineWise to conduct a new MedicineInsight data analysis into antidepressant utilisation in young people (aged under 25 years) attending general practice. The MedicineInsight report is now available on the NPS MedicineWise website.
This new analysis aligns with the findings of the TGA safety review and independent expert advice previously provided by the Advisory Committee on Medicines (ACM). The findings of this new analysis have been considered by the TGA and at Meeting 29 of the ACM. In particular, the ACM found that this analysis does not provide sufficient evidence to support a link between antidepressant use and suicide. The ACM considered that further regulatory action to limit prescriber or Pharmaceutical Benefits Scheme eligibility criteria for antidepressants is not justified on the strength of the current evidence. Additionally, it would further disadvantage children and adolescents, especially in regional, rural and remote areas where access to psychiatrists, paediatricians and psychological therapy is limited.
However, the ACM considered that this analysis reiterates the importance of appropriate dosing and education when health professionals prescribe antidepressants for children and adolescents.
The TGA has also published updated information about this issue for health professionals in a Medicines Safety Update article.
Background
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. These resources 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.
The TGA published the initial safety review report and a related safety alert in December 2020. An updated report was published in April 2021. The current analysis builds on the information available in this space.
