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Recent coronial inquiries into 2 deaths have highlighted the need for consumers and carers to be alert to the risks of using baclofen.
The risks of overdose are particularly pronounced when using high doses for off-label treatment of alcohol-use disorder.
The brand-name baclofen product in Australia is Lioresal and there are various generic versions available.
The registered condition for use (known as the ‘indication’) for baclofen is for the suppression of muscle spasm in:
- multiple sclerosis
- spinal lesions causing:
- stiff limbs
- some bladder dysfunctions.
Health professionals may choose to prescribe baclofen ‘off label’ for conditions other than the registered ones (see below for more information on off-label use).
The Therapeutic Goods Administration (TGA) requested an update to the Product Information (PI) and Consumer Medicine Information (CMI) for baclofen-containing products in 2019. The updates included warnings about the risk of suicide and suicide-related events, recommending close supervision of patients with alcohol-use disorder, depression and/or a history of previous suicide attempts.
The optimum dosage listed in the PI ranges from 30 to 75 mg daily, although occasionally doses up to 100 mg daily may be necessary in hospitalised patients. Higher dosages may be recommended for off-label use in alcohol-use disorder.
What patients should do
If you or someone you care for has been prescribed baclofen off label at high doses, be alert to the risks outlined above. If you are concerned, speak to your treating health professional for more detailed advice.
What is off-label use?
Off-label prescribing is a regular occurrence in the Australian healthcare system and internationally, particularly for uncommon diseases and conditions or in underrepresented patient groups.
Off-label use is a clinical decision, and the treating clinician is responsible for obtaining informed consent from their patients with discussion about the benefit–risk profile, including consideration of any other treatment options available.
The TGA does not regulate medical practitioners, clinical practice or clinical guidelines.
Information for health professionals
Our Medicines Safety Update article provides more information tailored for health professionals.