coronial inquiries into two recent deaths have highlighted the need for health professionals to be more alert to the well documented risk of overdose with baclofen, stated the TGA.
This risk relates to intentional and unintentional overdose and is particularly pronounced when baclofen is used off label at higher doses for alcohol-use disorder, the TGA added.
The regulator recommends close supervision of patients being treated with baclofen who have depression or a history of previous suicide attempts.
The optimum dosage listed ranges from 30 to 75mg daily, although higher dosages may be recommended for off-label use.
Patients and carers should be alerted to the need to monitor for clinical worsening, suicidal behaviour or thoughts, or unusual changes in behaviour.
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