ADR that result in revision of patient information
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| Australia: Use caution when prescribing baclofen off-label |
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Therapeutic Goods Administration (TGA) announces that recent coronial inquiries into 2 deaths have highlighted the need for health professionals to be alert to the well documented risk of overdose with baclofen. 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 registered indication for baclofen is for the suppression of voluntary muscle spasm in multiple sclerosis; and spinal lesions of traumatic, infectious, degenerative, neoplastic and unknown origin causing skeletal hypertonus, spastic and dyssynergic bladder dysfunction.
The Product Information (PI) and Consumer Medicine Information for baclofen products include 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 treating alcohol-use disorder.
Health professionals should be alert to the risk of overdose (intentional and unintentional) in patients taking baclofen off-label for alcohol-use disorder. Baclofen overdose is potentially fatal. If prescribing baclofen off-label, it is important to obtain informed consent from the patient after a discussion about the benefits and risks of the medicine, particularly at higher doses. Patients (and their carers) should be alerted to the need to monitor for clinical worsening, suicidal behaviour or thoughts, or unusual changes in behaviour. Medical advice should be sought immediately if these symptoms occur.
A search of TGA’s Database of Adverse Event Notifications on 28 Sep 2023 using search term ‘baclofen’, ‘overdose’ and ‘off-label use’ retrieved 43 cases of overdose reported (with 23 cases as single suspect); and 22 cases with off-label use reported (with 6 cases as single suspect).
This safety update is only applicable to the tablet form of baclofen, not baclofen for intrathecal injection.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/news/safety-updates/use-caution-when-prescribing-baclofen-label
In Hong Kong, there are 10 registered pharmaceutical products which are baclofen tablets. All products are prescription-only medicines. So far, the Department of Health (DH) has received 3 cases of adverse drug reaction related to baclofen, but these cases were not related to overdose. In light of the above TGA’s announcement, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Friday, Oct 20, 2023
Issued at HKT 16:00
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