其 他 安 全 警 示
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| Australia: Bupropion and serotonin syndrome (English only) |
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Therapeutic Goods Administration (TGA) announces that the Product Information (PI) documents for bupropion-containing products have been updated to include a warning about the risk of serotonin syndrome when this drug is co-administered with other drugs known to be associated with serotonin syndrome, including selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs). If concomitant treatment with other serotonergic agents is clinically warranted, careful observation of the patient is advised.
Bupropion is a selective inhibitor of the neuronal re-uptake of catecholamines (noradrenaline and dopamine) with minimal effect on the re-uptake of indolamines (serotonin) and no inhibitory effect on monoamine oxidase.
There are two products containing bupropion currently included on the Australian Register of Therapeutic Goods - Zyban SR and Contrave 8/90.
The 'Special Warnings and Precautions for Use' sections of the PI documents of bupropion products have been updated to add the following information:
Serotonin syndrome
Serotonin syndrome has been reported when bupropion is co-administered with drugs known to be associated with serotonin syndrome, including selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs). If concomitant treatment with other serotonergic agents is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
Serotonin syndrome has also been reported with overdosage.
The 'Interactions with Other Medicines and Other Forms of Interactions' section has been updated to add the following information:
Post-marketing data show a possible pharmacodynamics interaction between bupropion and SSRIs and SNRIs resulting in an increased risk of serotonin syndrome.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/publication-issue/bupropion-and-serotonin-syndrome
In Hong Kong, there are 6 registered pharmaceutical products containing bupropion, and all products are prescription-only medicines. Related news was previously issued by Medicines and Healthcare products Regulatory Agency, and was posted on the Drug Office website on 17 Nov 2020. Letters to inform local healthcare professionals concerning serotonin syndrome had been issued on the same day. So far, the Department of Health (DH) has received 4 cases of adverse drug reaction related to bupropion. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Saturday, Jul 3, 2021
Issued at HKT 13:15
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