Question Number: 186
PDR Number: SQ22-000556
Date Submitted: 21/11/2022
Department or Body: Department of Health
Methotrexate tablets are used to treat rheumatoid arthritis, severe psoriasis and some types of cancer. Since 2020, the Therapeutic Goods Administration (TGA) has received 48 adverse event reports for methotrexate that include a fatal outcome. Reporting an adverse event does not mean that it was caused by the medicine. It may be a coincidence, there may be other factors, or may be related to the patient’s underlying condition. In most cases the causal link cannot be definitively proven. Therefore, spontaneous adverse event data from the TGA database cannot be used to calculate incidence of a particular adverse event. Adverse event reports with a fatal outcome remain in the TGA database even if they have not been assessed as medicine related, so that they are included in the analyses to detect safety signals based on patterns of reporting. The TGA strongly encourages consumers and health professionals to report suspected adverse events, even if there is only a very small chance the medicine was the cause.
