The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
The Therapeutic Goods Administration (TGA) has continued its safety investigation of antidepressant use and the risk of suicide in young people. A recent NPS MedicineWise MedicineInsight analysis investigating antidepressant utilisation in young people attending general practice has been completed. The findings have been considered by the Advisory Committee on Medicines (ACM), with the overall findings aligning with the previous findings of the TGA and ACM.
The TGA published the initial safety review report, which included advice from the Advisory Committee on Medicines (ACM), and a related safety alert in December 2020. This report was updated in April 2021 and is available on the TGA website at: www.tga.gov.au/resource/antidepressant-utilisation-and-risk-suicide-young-people.
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 a causal relationship exists between prescribing of antidepressants and the rates of youth suicide.
Data analysis
NPS MedicineWise has completed an analysis of its MedicineInsight data on the prevalence of antidepressant prescribing, mental health and other relevant conditions for young people under the age of 25 years visiting a general practitice between 2011 and 2020.
MedicineInsight Report – Epidemiology of mental health conditions and antidepressant utilisation in people aged less than 25 years attending general practice is now available on the NPS MedicineWise website - external site.
The ACM has considered the new analysis report and found that further regulatory action to limit prescriber or Pharmaceutical Benefits Scheme eligibility criteria is not justified on the strength of the current evidence. Additionally, such actions could further disadvantage children and adolescents, especially in regional, rural and remote areas where access to psychiatrists, paediatricians and psychological therapy is limited. This aligns with previous ACM advice provided to the TGA in August 2020.
Key findings of the MedicineInsight analysis were:
- One in 10 (10.8%) young people aged less than 25 years had either a current or past history of depression and/or anxiety recorded in 2018–19.
- Among patients aged less than 25 years with a newly recorded diagnosis of depression during 2018 or 2019, over 70% had a mental health care plan or referral to a mental health specialist. A smaller proportion (63%) were prescribed at least one antidepressant medication, with an average time of approximately 7 weeks between diagnosis and first prescription.
- Between 2011 and 2020, both the prevalence of recorded depression and the prescribing rate of antidepressants increased by around 1.8-fold.
- Very few suicides were recorded in this dataset. However, the recorded rates of suicide attempt, suicide ideation and self-harm in patients have increased at least three-fold over a 10-year period.
- Co-prescribing of other psychotropic medications in general practice was reassuringly low, noting specialist prescribing was not captured. In 2018–19, an antidepressant was uncommonly prescribed on the same day as an antipsychotic (8.7% of the patients), benzodiazepine/z-drug (7.1%) or ADHD stimulant (2.6%).
The ACM also noted that the analysis includes 2020 data, and that the various impacts of the COVID-19 pandemic on mental health, demand for services and availability of telehealth services, were not yet known.
Information for health professionals
When prescribing antidepressants, particularly off-label in paediatric and adolescent populations, health professionals should take extra care regarding dosing to effectively balance the benefits and risks for individual patients. Additionally patients and their family members should be educated on the risk of suicidal ideation, especially in the first month of therapy, and the general benefits and risks of pharmacotherapy.
The TGA has shared this information and the MedicineInsight analysis with relevant medical colleges, including the Royal Australian College of General Practitioners and the Royal Australian and New Zealand College of Psychiatrists. It is hoped that this will also assist with the production of prescriber education materials and clinical guidelines.
What to report? You don't need to be certain, just suspicious!
The TGA encourages the reporting of all suspected adverse reactions to medicines, including vaccines, over-the-counter medicines, herbal, traditional or alternative remedies.
We particularly request reports of:
- all suspected reactions to new medicines (look for the Black Triangle in PI and CMI documents - this symbol identifies medicines that are new or being used differently)
- all suspected medicines interactions
- suspected reactions causing death, admission to hospital or prolongation of hospitalisation, increased investigations or treatment, or birth defects.
Reports may be submitted:
- online at www.tga.gov.au
- by fax to 02 6232 8392
- by email to ADR.Reports@tga.gov.au
For more information about reporting, visit www.tga.gov.au or contact the TGA's Pharmacovigilance and Special Access Branch ADR.Reports@tga.gov.au.
Disclaimer
Medicines Safety Update is aimed at health professionals. It is intended to provide practical information to health professionals on medicine safety, including emerging safety issues. The information in Medicines Safety Update is necessarily general and is not intended to be a substitute for a health professional's judgment in each case, taking into account the individual circumstances of their patients. Reasonable care has been taken to ensure that the information is accurate and complete at the time of publication. The Australian Government gives no warranty that the information in this document is accurate or complete, and shall not be liable for any loss whatsoever due to negligence or otherwise arising from the use of or reliance on this document.
© Commonwealth of Australia 2022
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For correspondence or further information about Medicines Safety Update, contact the TGA's Pharmacovigilance and Special Access Branch at ADR.Reports@tga.gov.au.
Medicines Safety Update is written by staff from the Pharmacovigilance and Special Access Branch.
Acting Editor: Dr Catherine Brogan
Deputy Editor: Mr Michael Pittman
Contributor: Ms Prajakta Narvekar, Ms Sarah May, Dr Jessica Tidemann and Dr Catherine Brogan