Pharmacy Daily | Off-label misuse is leading to deaths

THE off-label misuse of a prescribed antispasmodic baclofen has claimed the lives of more than 30 patients in the past decade, the Victorian Coroner Audrey Jamieson reported in AusDoctor today.

Jamieson was investigating the death of a 64-year-old this month from overdosing when she ordered the Coroners Prevention Unit to review baclofen overdose data.

AusDoc said the data uncovered 34 deaths in Victoria from 2012 to 2021, including 17 deaths of patients with a history of alcohol use disorder, with the "vast majority" of all deaths a result of intentional self-harm.

The source of baclofen, when it was identifiable, was most often scripts to manage alcohol cravings, Jamieson said.

"The PI [product information], however, contains a warning that baclofen taken in combination with alcohol increases the risk of respiratory depression and sedation, and therefore, it should be used with caution where patients have a history of alcoholism."

The woman was found dead at her home in Apr 2020.

Police found glasses of red wine with a "cloudy colour/layer" and two bowls: one with tablets and the other with powder residue.

Toxicological analysis revealed baclofen levels of about 5.5mg/L.

Jamieson said the patient had received two scripts for 100 tablets of baclofen 10mg in Jan 2019 from a general physician at a private hospital.

The patient filled both scripts at once in Aug 2019, suggesting a plan to stockpile the drug, but Jamieson said there was no way of telling whether the tablets in the overdose were from the two scripts.

The Coroner said guidelines warned baclofen was not a first-line treatment for alcohol disorders and "should be prescribed with caution" yet "may be considered in specialist settings".

She called for the TGA to extend baclofen's indication to include alcohol use disorder so doctors had guidance on how it should be used.

"In my view, the weight of the available evidence indicates that a TGA-approved model could reduce the risk of a misguided subjective assessment by an individual clinician of his patient in prescribing baclofen," she said, adding there may be other more appropriate and effective measures as well.