THE Therapeutic Goods Administration (TGA) has advised that the product information (PI) and consumer medicine information (CMI) leaflets for acne medication isotretinoin (Roaccutane and generics) contain updated safety information with regards to mental health and sexual disorders.
The update includes: new advice to conduct a mental health assessment for all patients before starting isotretinoin; how to manager mood-related changes; and new warnings and advice about sexual health-related side effects.
Health professionals are advised to look out for potential psychiatric and sexual disorders with isotretinoin, especially in adolescents, and prescribers should assess patients' mental health and their family history of mental health conditions before starting the drug.
If mood-related changes occur, the treatment should be stopped immediately and specialist advice sought if symptoms continue after stopping.
Health professionals should also provide the CMI to patients if needed and alert them of the new warnings.
The updated information comes after a TGA investigation to review all current information on psychiatric and sexual disorders associated with the drug.
The investigation concluded that an association between isotretinoin and psychiatric/sexual disorders could not be ruled out, and an update to the product information was recommended as a precautionary measure, and to align with international regulators.
More information is HERE.
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