TGA - Therapeutic Goods Administration

05/21/2019 | Press release | Distributed by Public on 05/21/2019 00:50

Fallopia multiflora (he shou wu)

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


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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.

Reporting problems

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

安全公告-肝损伤可能

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。

澳大利亚规定在列药品中可以使用何首乌。在列药品由产品标签上的'AUST L'数字标识。含有何首乌的在列药品可以从一系列供应商,包括通过保健食品商店和传统中医执业者购买。

极少数情况下,何首乌与低风险度的肝损伤有关。因此,澳大利亚治疗产品管理局要求含有何首乌的在列口服药品在产品标签上提供以下警告:'警告:何首乌可能导致一些人的肝损伤。应在健康保健专业人士监督下使用。'

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。

此外,目前进行对何首乌的安全调查发现一些由传统中医执业者出售的产品没有按要求提供安全警告,这些产品 已被召回。

消费者信息

服用含有何首乌产品的消费者 应注意在极少数情况下肝损伤的可能性。

如果出现以下任何症状,消费者应停止服用该产品并寻求医疗建议:皮肤或眼睛发黄,尿色深,恶心,呕吐,异常疲倦,虚弱,胃痛或腹痛和/或食欲不振。

建议消费者与其健康专业人士讨论任何有关疑虑或问题。

健康专业人士信息

健康专业人士应注意,在极少数情况下,一些非西药辅助药物可能导致一些人的肝损害。 在治疗出现肝损症状的患者时,健康专业人士应考虑肝损是否与辅助药物有关。

厂商信息

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。

也提醒厂商有义务在规定的时间内向治疗产品管理局报告所有严重不良反应事件。

报告问题

治疗产品管理局鼓励消费者和健康专业人士报告药物或疫苗的问题。您的报告将有助于我们对这些产品的监控。

治疗产品管理局无法就个人的健康状况提供建议。如果您担心可能与药物或疫苗相关的不良反应事件,强烈建议您向健康专业人士咨询。