Consumers and health professionals are advised that Global Therapeutics, in consultation with the TGA, is recalling its Fusion Hair Tonic and Oriental Botanicals Hairpro products due to the risk of liver injury in rare cases.
The recalled products contain Fallopia multiflora.
Fallopia multiflora (he shou wu)
Safety advisory - potential for liver damage (statement includes Chinese translation 中文翻译)
29 April 2019
A Chinese translation 中文翻译 of this information is available below.
Fallopia multiflora (also called Polygonum multiflorum, Fo ti, Reynoutria multiflora and Chinese fleeceflower root) is a herb, also known by the Chinese name 'he shou wu'. It is marketed for hair thinning, 'blood tonifying' and a variety of other conditions.
Fallopia multiflora is permitted for use in listed medicines in Australia. Listed medicines are identified by an 'AUST L' number on the label. Listed medicines that contain Fallopia multiflora are available from a range of suppliers including through health food stores and through Traditional Chinese Medicine (TCM) practitioners.
Fallopia multiflora has been associated with a low risk of liver damage in rare cases. As a consequence, it is a requirement that listed medicines containing Fallopia multiflora for oral use to have the following warning on the product label: 'Warning: Fallopia multiflora may harm the liver in some people. Use under the supervision of a healthcare professional.'
The TGA has received reports of nine cases of liver damage in consumers taking products containing Fallopia multiflora, in the period spanning 2008 to 2018. In response to these reports, a safety investigation has been initiated looking at the products involved, and the ingredient Fallopia multiflora. Outcomes of this investigation will be notified when available. Regulatory actions may include cancellation of any products with unacceptable safety, or changes to the requirements for ingredients permitted for use in listed medicines.
In addition, as part of the ongoing safety investigation of Fallopia multiflora, it was identified that a number of products available through TCM practitioners did not include the required warning, and those affected products have been recalled.
Information for consumers
Consumers taking products containing Fallopia multiflora should be aware of the potential for liver damage which may occur in rare cases.
Consumers should stop taking the product and seek medical advice if they experience any of the following symptoms: yellowing of the skin or eyes, dark urine, nausea, vomiting, unusual tiredness, weakness, stomach or abdominal pain and/or loss of appetite.
Consumers are advised to discuss any concerns or questions about this issue with their health professional.
Information for health professionals
Health professionals should be aware that, in rare circumstances, some complementary medicines may cause liver damage in some individuals. When treating patients presenting with symptoms of liver damage, health professionals should consider whether a complementary medicine could be involved.
Information for sponsors
Sponsors are reminded of their obligations to comply with the requirements of the permissible ingredients determination. Failure to do so will lead to regulatory action, which may include the recall and/or cancellation of a product.
Sponsors are also reminded of their obligation to report all serious adverse events to the TGA within required timeframes.
Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.
何首乌（亦称多花蓼,Fo ti，Reynoutria multiflora，Chinese fleeceflower root）是一种草药。 市场销售的何首乌适用于头发稀疏，“补血”和各种其他病症。
澳大利亚治疗产品管理局（TGA）在2008年至2018年期间收到9例消费者服用含有何首乌药品肝损伤的报告。对于这些报告， 我局已启动针对所涉及的产品以及何首乌的安全调查。 我局将会公布调查结果。可能采取的监管行动包括：取消任何安全性不可接受的产品注册资格，或改变对在列药品允许使用成分的要求。
提醒厂商有义务遵守 允许成分决定 的要求。违反要求将导致可能包括召回产品和/或取消产品注册资格的监管行动。