TGA issues baclofen warning to doctors in response to overdose deaths

The antispasmodic can help but only in rare cases, says Dr Hester Wilson.

The TGA is urging caution with off-label baclofen prescribing for alcohol use disorder in the wake of coronial inquiries into two deaths.

While elevated suicide risk with baclofen is known for patients with psychiatric disorders, the regulator is now warning the risk of intentional or unintentional overdose is “particularly pronounced” with off-label prescribing at higher doses.

The safety alert followed findings from March by Victorian Coroner Audrey Jamieson, who investigated the overdose death of a 64-year-old woman from combined alcohol and baclofen toxicity.

The inquiry uncovered 34 similar deaths across the state from 2012 to 2021, including 17 deaths of patients with a history of alcohol use disorder.