The Therapeutic Goods Administration (TGA) has published a safety alert regarding the use of high doses of baclofen. This alert has been issued following recent coronial inquiries into two deaths.

Baclofen is a skeletal muscle relaxant indicated for chronic spasticity of spinal or cerebral origin. The usual oral dose range for these patients is 30-75mg daily (given in three divided doses). However, baclofen is sometimes prescribed off-label for the management of alcohol-use disorder. There is no universally accepted dosing recommendation in this setting, and higher doses are often used.

Baclofen is a structural analogue of gamma-aminobutyric acid (GABA) and can cause significant depression of the central nervous system (CNS). The TGA advises health professionals to be aware of the risk of intentional and unintentional overdose in patients taking baclofen for alcohol-use disorder. Symptoms of overdose may include reduced consciousness, respiratory depression, hyporeflexia, convulsions, and cardiac arrhythmias. Deterioration is more likely if combined with other CNS depressants.

References:

  1. Lioresal® (Baclofen) Australian approved product information. Macquarie Park: Novartis. Approved March 2022.
  2. Sinclair A, Heydtmann JM, Addolorato M, Aubin G, Beraha J, Caputo EM, et al. The use of baclofen as a treatment for alcohol use disorder: a clinical practice perspective. Front Psychiatry. 2018; 9: 708.

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