Assess mental health before prescribing isotretinoin: TGA safety update
The TGA said it had received 117 serious psychiatric adverse event reports.
The TGA has updated the safety warnings for isotretinoin, advising doctors to conduct mental health assessments before prescribing the acne drug.
The update also says to monitor for psychological and sexual health side effects during treatment.
“All patients should have an assessment of their mental health and of family history of mental health conditions before starting treatment,” the updated product information says.
Overseas regulators had already strengthened their warnings on the retinoid — indicated for severe acne if standard therapy had failed — before a 2024 TGA investigation “concluded that an association between isotretinoin and psychiatric/sexual disorders could not be ruled out”.
