TGA warning on off-label use of medicines


Health professionals should use caution when considering ‘off-label’ prescribing for their patients, according to the latest TGA Medicines Safety Update.

Prescribers should be prepared to fully discuss the risks and benefits of the proposed treatment with the patient and/or their carers so that they are capable of providing informed consent.

This includes situations where the Product Information (PI) for a medicine is updated in a way that makes continued use of a medicine ‘off label’.

The TGA reiterated that registered medicines have been evaluated for safety and efficacy for approved indications, as described in the medicine’s PI.

Any use of medicines outside of those indications, dose, route of administration or patient group constitutes off-label prescribing.

“The TGA recognises that off-label prescribing may be clinically appropriate in some circumstances, but recommends that such use only be considered when other options are unavailable, exhausted, not tolerated or unsuitable,” the Update said.

“Additionally, the treatment, including its effectiveness and potential adverse events, should be monitored.”

The TGA Medicines Safety Update also urged prescribers to report any suspected adverse events that occur during off-label use of medicines.

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