其 他 安 全 警 示
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| Australia: Medicines containing turmeric or curcumin: risk of liver injury (English only) |
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Therapeutic Goods Administration (TGA) announces that medicines and herbal supplements containing the herb Curcuma longa (turmeric) and/or curcumin may cause liver injury in rare cases. This risk also relates to other ingredients from the Curcuma species as they contain naturally occurring curcumin: Curcuma aromatica, Curcuma zanthorrhiza and Curcuma zedoaria.
The TGA has received 18 reports of liver problems experienced by consumers taking products containing Curcuma longa (turmeric) and/or curcumin up to 29 Jun 2023. Nine of these reports had enough information to suggest a liver injury that may have been caused by the Curcuma longa (turmeric) or curcumin product. Of these, in 4 cases there were no other ingredients likely to have contributed to the liver injury. Two of these cases were severe, including one that had a fatal outcome. The other 5 cases involved products that contained other ingredients that may have contributed to liver injury. In addition to these cases, there have been several Australian and overseas case reports in the scientific literature, and multiple cases reported to regulators in other countries.
In response to these reports, the TGA completed a safety investigation of the ingredients Curcuma longa (turmeric) and curcumin and the risk of liver injury. Available evidence shows that there is a rare risk of liver injury from taking Curcuma longa (turmeric) and/or curcumin in medicinal dosage forms. The risk may be higher for products with enhanced absorption or bioavailability and/or higher doses. People with existing or previous liver problems may be more likely to develop this rare adverse event. However, there is not enough information at this time to conclusively identify which medicines are higher risk. The TGA will continue to monitor this issue and is currently considering further regulatory action, including consultation on a label warning. The TGA will publish the outcome of this consultation including the details of any new labelling requirements in late 2023.
Health professionals should be aware that products containing Curcuma longa (turmeric), Curcuma aromatica, Curcuma zanthorrhiza, Curcuma zedoaria and/or curcumin may cause liver injury in some individuals. When treating patients who are presenting with symptoms of liver injury, health professionals should consider whether a complementary medicine could be involved. Use of medicines or herbal supplements containing the above Curcuma species and/or curcumin should be avoided in patients with existing or previous liver pathologies.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/news/safety-alerts/medicines-containing-turmeric-or-curcumin-risk-liver-injury
In Hong Kong, there is one registered pharmaceutical product containing curcuma root, namely Liver Bile Soft Gelatin Cap (Lambo) (HK-40165). The product is registered by Leeport Pharm Co Ltd. It is an over-the-counter medicine. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to turmeric or curcumin. As TGA is currently considering further regulatory action, the DH will remain vigilant on safety update of the drug issued by TGA and other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Wednesday, Aug 16, 2023
Issued at HKT 15:30
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