TGA Warns on Atomoxetine Homicidal Ideation Risk, Publishes February 2026 PI Updates
The TGA warned about the risk of homicidal ideation associated with atomoxetine in paediatric patients and published its February 2026 Product Information safety updates. The updates cover multiple medicines with changes to contraindications, warnings and adverse effects. Nearly one in five Australians took a prescription psychiatric drug in 2023-24.
The Therapeutic Goods Administration (TGA) has issued a warning about the risk of homicidal ideation associated with the ADHD drug atomoxetine in paediatric patients, part of a series of psychiatric drug safety alerts. The regulator has also published its monthly Product Information (PI) safety updates for February 2026, covering a range of medicines with changes to contraindications, warnings and adverse effect information.
In May and June 2025, the TGA issued warnings about the risk of homicidal ideation associated with atomoxetine in paediatric patients. The TGA had received a report as far back as 2009 of homicidal ideation in an eight-year-old child taking the drug. Since 2006, atomoxetine has carried Australia's strongest boxed warning for suicidal thoughts and behaviour, with additional warnings following, including one issued after the suicide of a nine-year-old child in 2013. The global atomoxetine hydrochloride market was estimated at USD 1.2 billion in 2024.
In 2024, the TGA warned of suicidality associated with lisdexamfetamine (Vyvanse), another ADHD drug. Australia's Product Information for dexamfetamine lists overdose effects including aggressiveness and suicidal or homicidal tendencies. In 2005, the TGA warned that selective serotonin reuptake inhibitors (SSRIs) carry a risk of suicidality in both children and adults, and in 2016 and 2018 it warned that all antidepressants carry a risk of suicidal behaviour and suicidal thinking. More than 100 international drug regulatory agency warnings caution that psychiatric drugs may induce violent, hostile or aggressive behaviour in a percentage of users.
Nearly one in five Australians took a prescription psychiatric drug in 2023-24. A 2018 Australian survey found that more than half of hospital inpatients and one-third of community-based patients reported receiving no medicines information at all. Following its National Mental Health Inquiry, the Australian Productivity Commission recommended in 2020 that all psychiatric prescriptions include a clear statement confirming clinicians had discussed side effects and evidence-based alternatives; the Commission stated the reform should "start now", but it has still not been implemented.
The TGA monitors the safety of medicines marketed in Australia using reports of adverse events, Risk Management Plans, Periodic Safety Update Reports, reviews of literature, and information sharing with other regulatory agencies and Australian state and territory health authorities. When new safety information is identified, the TGA works with sponsors to update Product Information. Changes may narrow indications or add or modify sections such as contraindications, warnings or precautions, use in fertility, pregnancy and lactation, use in special populations, and adverse effects. Significant PI changes are often supported by a Dear Health Care Professional Letter. The TGA publishes a Medicines Safety Update article detailing recent safety-related PI updates each month.
In updates approved in January and February 2026, PI changes were made for a range of medicines, including acarbose, bivalirudin, ceftaroline fosamil, doxorubicin hydrochloride, estradiol hemihydrate, itraconazole, larotrectinib sulfate, leflunomide, metronidazole, and ofatumumab, among others. Changes included added contraindications, updated warnings and precautions, and new adverse effect information. Generic brands containing the same active ingredients are required to align with the safety information in the innovator's PI.