he shou wu, Fallopia multiflora and the potential for liver damage - TGA Safety advisory

Fallopia multiflora (he shou wu)

Safety advisory - potential for liver damage (statement includes Chinese translation 中文翻译) Scroll down.

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.

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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。

• Category:Alert/Advisory
• Tags:herbal medicines
• URL:https://www.tga.gov.au/node/874503

2019 Australian seasonal influenza vaccines Information for consumers and health professionals

2019 Australian seasonal influenza vaccines

Information for consumers and health professionals

17 April 2019
Influenza vaccines can change from year to year as new strains of influenza virus appear. This is one reason vaccination against influenza is given every year.

The Australian Influenza Vaccine Committee (AIVC) has reviewed data related to epidemiology, antigenic and genetic characteristics of recent influenza isolates circulating in Australia and the Southern Hemisphere, serological responses to previous year's vaccines, and the availability of candidate vaccines viruses and reagents. Based on this review and the World Health Organization's recommendation, the AIVC recommended the following viruses be used for influenza vaccines in the 2019 southern hemisphere influenza season.

The TGA has accepted the recommendations of AIVC. This year there is a new A strain (H3N2) and a new strain for the B Victoria lineage. Details of the strains were announced on the TGA website on 15 October 2018.

The Influenza virus strains that are included in the 2019 southern hemisphere seasonal influenza vaccines are listed below.

The egg-based quadrivalent influenza vaccines contain the following four viral strains:

an A/Michigan/45/2015 (H1N1)pdm09-like virus
an A/Switzerland/8060/2017 (H3N2)-like virus
a B/Colorado/06/2017-like virus (B/Victoria/2/87 lineage)
a B/Phuket/3073/2013-like virus (B/Yamagata/16/88 lineage)
The egg-based trivalent influenza vaccines contain the following three viral strains:

an A/Michigan/45/2015 (H1N1)pdm09-like virus;
an A/Switzerland/8060/2017 (H3N2)-like virus; and
a B/Phuket/3073/2013-like (B/Yamagata/16/88 lineage)
On this page: Registered products | Vaccines for use in children | Vaccines for use in over 65s | Vaccines for use in over 65s | Further information | Reporting of adverse events following influenza vaccine

Registered products

For the 2019 influenza season, the TGA has registered six vaccines which will be available for use in the following age groups:

Sponsor	Tradename	Age group
Quadrivalent vaccines
Sanofi-Aventis	FluQuadri Junior	6-35 months* (<3 nbsp="" td="" years="">
	FluQuadri	3 years and over
GlaxoSmithKline	Fluarix Tetra	6 months and over**
Mylan Health	Influvac Tetra	18 years and over***
Seqirus	Afluria Quad	5 years and over
Trivalent vaccines
Seqirus	Fluad	65 years and over
Sanofi-aventis	Fluzone high dose	65 years and over***

• * Guidance for the dose in children aged 6–35 months is available in the Product Information.
• ** A full 0.5 mL dose is now to be used in all age groups 6 months and over
• *** For private market only, not funded under the National Immunisation Program (NIP).

For further information on individual vaccines, please refer to the relevant Product Information document or Consumer Medicine Information document.

The 2019 seasonal influenza vaccines will be available through the NIP from mid-April 2019.

In conjunction with the Office of Health Protection and state and territory health authorities, the TGA will be closely monitoring adverse event reports during the 2019 influenza vaccination program.

All influenza vaccines available this year are Latex free.

Vaccines for use in children
For children FluQuadri Junior is available from 6 to 35 months, FluQuadri for 3 years and over and Fluarix Tetra for 6 months and over. Afluria Quad is available for use in children aged 5 years and over.

Vaccines for use in under 65s
Quadrivalent influenza vaccine brands are being supplied under the NIP in 2019 for people aged under 65. These vaccines include two influenza A strains and two influenza B strains.

Vaccines for use in over 65s
To continue to provide the best possible protection for those 65 years and over, an enhanced trivalent vaccine, Fluad (Seqirus), is being supplied through the NIP for this age group in 2019. This vaccine has been specifically made for the elderly, as their immune systems respond less effectively to vaccines. As a trivalent vaccine, it includes two influenza A strains and one influenza B strain. It works by generating a stronger immune response through the use of an adjuvant which stimulates the immune system. An additional trivalent influenza vaccine for those aged 65 years and older, Fluzone High Dose (Sanofi), is anticipated to be available for purchase on the private market.

Further information
Information for health professionals is available from the Australian Technical Advisory Group on Immunisation (ATAGI) Influenza Statement.

For more information see Influenza vaccine: the annual Southern Hemisphere influenza vaccine production and the regulatory approval timeline.

Reporting of adverse events following influenza vaccine
Health professionals and consumers are encouraged to report all adverse events associated with influenza vaccination in patients of any age to the TGA or through the current arrangements in their state or territory.

All reports contribute to the TGA's ongoing monitoring of the safety of influenza vaccines.

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 vaccine or medicine.

Category:Alert/Advisory
Tags:seasonal influenza vaccines, influenza vaccines
URL:https://www.tga.gov.au/node/874489

BMSW 4600MG Black Ant Capsules Poses A Serious Health Risk.

BMSW 4600MG Black Ant Capsules

TGA Safety advisory

BMSW 4600MG Black Ant Capsules pose a serious risk to your health and should not be taken.

The Therapeutic Goods Administration (TGA) has tested a product labelled BMSW 4600MG Black Ant Capsules and found that:

• The capsules contain the undeclared substance Sildenafil.

Consumers are advised that Sildenafil is a prescription-only (S4) medicine in Australia.

The supply of BMSW 4600MG Black Ant Capsules containing undisclosed Sildenafil is illegal.

BMSW 4600MG Black Ant Capsules have not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation, and the place of manufacture is not approved by the TGA.

Information for consumers

• Stop taking BMSW 4600MG Black Ant Capsules and take any remaining capsules to your local pharmacy for safe disposal.
• If you have any concerns arising from your use of this product, consult your health care practitioner.

Action the TGA is taking

The TGA is working with the Australian Border Force (ABF) to help stop future shipments of BMSW 4600MG Black Ant Capsules from entering Australia.

If these capsules are found at the border by the ABF they will be seized and destroyed.

The TGA is advising consumers to exercise extreme caution when purchasing medicines from unknown overseas internet sites and has produced a short video on the risks associated with buying medicines and medical devices online. Products purchased over the internet:

• may contain undisclosed and potentially harmful ingredients
• may not meet the same standards of quality, safety and efficacy as those approved by the TGA for supply in Australia.

Double Maxx D.B.M. Capsules Are A Serious Risk to Your Health and Should Not be Taken. - TGA Advisory

Double Maxx D.B.M. Capsules pose a serious risk to your health and should not be taken.

The Therapeutic Goods Administration (TGA) has tested a product labelled Double Maxx D.B.M. Capsules and found that:

• The capsules contain the undeclared substance Sildenafil.

Consumers are advised that Sildenafil is a prescription-only (S4) medicine in Australia.

The supply of Double Maxx D.B.M. Capsules containing undisclosed Sildenafil is illegal.

Double Maxx D.B.M. Capsules have not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation, and the place of manufacture is not approved by the TGA.

Information for consumers

• Stop taking Double Maxx D.B.M. Capsules and take any remaining capsules to your local pharmacy for safe disposal.
• If you have any concerns arising from your use of this product, consult your health care practitioner.

Action the TGA is taking

The TGA is working with the Australian Border Force (ABF) to help stop future shipments of Double Maxx D.B.M. Capsules from entering Australia.

If these capsules are found at the border by the ABF they will be seized and destroyed.

The TGA is advising consumers to exercise extreme caution when purchasing medicines from unknown overseas internet sites and has produced a short video on the risks associated with buying medicines and medical devices online. Products purchased over the internet:

• may contain undisclosed and potentially harmful ingredients
• may not meet the same standards of quality, safety and efficacy as those approved by the TGA for supply in Australia.

Lotus Flower Capsules pose a serious risk to your health and should not be taken, The Therapeutic Goods Administration (TGA)

Lotus Flower Capsules

Safety advisory

3 April 2019

Lotus Flower Capsules pose a serious risk to your health and should not be taken.

The Therapeutic Goods Administration (TGA) has tested a product labelled Lotus Flower Capsules and found that:

• The capsules contained a derivative of fenfluramine. Fenfluramine is a prescription-only (S4) synthetic anorexic drug, which is no longer available for sale in Australia following its withdrawal from the U.S. market in 1997 after reports of heart valve disease and pulmonary hypertension were associated with its use.

Consumers are advised that in Australia, glibenclamide is a prescription-only substance and oral diclofenac is a pharmacy only substance. 2-Mercaptobenzothiazole has no known therapeutic use.

The supply of Lotus Flower Capsules containing the undisclosed derivative of fenfluramine is illegal.

Lotus Flower Capsules have not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation, and the place of manufacture is not approved by the TGA.

Information for consumers

• Stop taking Lotus Flower Capsules and take any remaining capsules to your local pharmacy for safe disposal.
• If you have any concerns arising from your use of this product, consult your health care practitioner.

Action the TGA is taking

The TGA is working with the Australian Border Force (ABF) to help stop future shipments Lotus Flower Capsules from entering Australia.

If these capsules are found at the border by the ABF they will be seized and destroyed.

The TGA is advising consumers to exercise extreme caution when purchasing medicines from unknown overseas Internet sites and has produced a short video on the risks associated with buying medicines and medical devices online. Products purchased over the internet:

• may contain undisclosed and potentially harmful ingredients
• may not meet the same standards of quality, safety and efficacy as those approved by the TGA for supply in Australia.

Report counterfeit medicines and medical devices

If you are worried about counterfeit medicines or medical devices, and want to report an issue, you can report the matter to the TGA:

Contact details

Phone	1800 020 653
Online:	Report a perceived breach of the Therapeutic Goods Act or questionable practices relating to therapeutic products
Email	info@tga.gov.au

• Category:Alert/Advisory
• Tags:buying online
• URL:https://www.tga.gov.au/node/874446

Magnum XXL Capsules pose a serious risk to your health and should not be taken, The Therapeutic Goods Administration (TGA).

Magnum XXL Capsules

Safety advisory

3 April 2019

Magnum XXL Capsules pose a serious risk to your health and should not be taken.

The Therapeutic Goods Administration (TGA) has tested a product labelled Magnum XXL Capsules and found that:

• The capsules contain the undeclared substance Tadalafil.

Consumers are advised that Tadalafil is a prescription-only medicine in Australia.

The supply of Magnum XXL Capsules containing undisclosed Tadalafil is illegal.

Magnum XXL Capsules have not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation, and the place of manufacture is not approved by the TGA.

Information for consumers

• Stop taking Magnum XXL Capsules and take any remaining capsules to your local pharmacy for safe disposal.
• If you have any concerns arising from your use of this product, consult your health care practitioner.

Action the TGA is taking

The TGA is working with the Australian Border Force (ABF) to help stop future shipments of Magnum XXL Capsules from entering Australia.

If these capsules are found at the border by the ABF they will be seized and destroyed.

The TGA is advising consumers to exercise extreme caution when purchasing medicines from unknown overseas internet sites and has produced a short video on the risks associated with buying medicines and medical devices online. Products purchased over the internet:

• may contain undisclosed and potentially harmful ingredients
• may not meet the same standards of quality, safety and efficacy as those approved by the TGA for supply in Australia.

Report counterfeit medicines and medical devices

If you are worried about counterfeit medicines or medical devices, and want to report an issue, you can report the matter to the TGA:

Contact details

Phone	1800 020 653
Online:	Report a perceived breach of the Therapeutic Goods Act or questionable practices relating to therapeutic products
Email	info@tga.gov.au

• Category:Alert/Advisory
• Tags:buying online
• URL:https://www.tga.gov.au/node/874457

X Power 3 Tablets pose a serious risk to your health and should not be taken, TGA Health Advisory,

X Power 3 Tablets

Safety advisory

3 April 2019

X Power 3 Tablets pose a serious risk to your health and should not be taken.

The Therapeutic Goods Administration (TGA) has tested a product labelled X Power 3 Tablets and found that:

• The tablets contain the undeclared substance Sildenafil.

Consumers are advised that Sildenafil is a prescription-only medicine in Australia.

The supply of X Power 3 Tablets containing undisclosed Sildenafil is illegal.

X Power 3 Tablets have not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation, and the place of manufacture is not approved by the TGA.

Information for consumers

• Stop taking X Power 3 Tablets and take any remaining tablets to your local pharmacy for safe disposal.
• If you have any concerns arising from your use of this product, consult your health care practitioner.

Action the TGA is taking

The TGA is working with the Australian Border Force (ABF) to help stop future shipments of X Power 3 Tablets from entering Australia.

If these tablets are found at the border by the ABF they will be seized and destroyed.

The TGA is advising consumers to exercise extreme caution when purchasing medicines from unknown overseas internet sites and has produced a short video on the risks associated with buying medicines and medical devices online. Products purchased over the internet:

• may contain undisclosed and potentially harmful ingredients
• may not meet the same standards of quality, safety and efficacy as those approved by the TGA for supply in Australia.

Report counterfeit medicines and medical devices

If you are worried about counterfeit medicines or medical devices, and want to report an issue, you can report the matter to the TGA:

Contact details

Phone	1800 020 653
Online:	Report a perceived breach of the Therapeutic Goods Act or questionable practices relating to therapeutic products
Email	info@tga.gov.au

• Category:Alert/Advisory
• Tags:buying online
• URL:https://www.tga.gov.au/node/874456

JOYSMI capsules pose a serious risk to your health and should not be taken. Contains undeclared substances sibutramine, phenolphthalein and frusemide. - TGA

Therapeutic Goods Administration Australia - TGA

JOYSMI capsules pose a serious risk to your health and should not be taken.

3 April 2019

The Therapeutic Goods Administration (TGA) has tested a product labelled JOYSMI capsules and found that:

• The capsules contain the undeclared substances sibutramine, phenolphthalein and frusemide.

Consumers are advised that in Australia:

• Sibutramine is a prescription-only substance (which was the active ingredient in Reductil). It was withdrawn in October 2010 after a study showed an increased risk of major cardiac events.
• Phenolphthalein is a prescription-only substance previously marketed as an oral laxative, withdrawn from sale in the late 1990’s due to concerns over its carcinogenicity with long term use.
• Frusemide is a prescription-only substance used for the treatment of oedema and high blood pressure.

The supply of JOYSMI capsules containing undisclosed sibutramine, phenolphthalein and frusemide is illegal.

JOYSMI capsules have not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation, and the place of manufacture is not approved by the TGA.

Information for consumers

• Stop taking JOYSMI capsules and take any remaining capsules to your local pharmacy for safe disposal.
• If you have any concerns arising from your use of this product, consult your health care practitioner.

Action the TGA is taking

The TGA is working with the Australian Border Force (ABF) to help stop future shipments of JOYSMI capsules from entering Australia.

If these capsules are found at the border by the ABF they will be seized and destroyed.

The TGA is advising consumers to exercise extreme caution when purchasing medicines from unknown overseas internet sites and has produced a short video on the risks associated with buying medicines and medical devices online. Products purchased over the internet:

• may contain undisclosed and potentially harmful ingredients
• may not meet the same standards of quality, safety and efficacy as those approved by the TGA for supply in Australia.

Report counterfeit medicines and medical devices

If you are worried about counterfeit medicines or medical devices, and want to report an issue, you can report the matter to the TGA:

Contact details

Phone	1800 020 653
Online:	Report a perceived breach of the Therapeutic Goods Act or questionable practices relating to therapeutic products
Email	info@tga.gov.au

• Category:Alert/Advisory
• Tags:buying online
• URL:https://www.tga.gov.au/node/874455

Stop taking Meizitang Botanical Soft Gel Capsules These pose a serious risk to your health and should not be taken - TGA

Therapeutic Goods Administration Australia, #TGA

Meizitang Botanical Soft Gel Capsules

Meizitang Botanical Soft Gel Capsules pose a serious risk to your health and should not be taken

3 April 2019

The Therapeutic Goods Administration (TGA) has tested a product labelled Meizitang Botanical Soft Gel Capsules and found that:

• The capsules contain the undeclared substance Sildenafil & Sildenafil N-Oxide.

Consumers are advised that Sildenafil & Sildenafil N-Oxide are prescription-only substances in Australia.

The supply of Meizitang Botanical Soft Gel Capsules containing undisclosed Sildenafil & Sildenafil N-Oxide is illegal.

Meizitang Botanical Soft Gel Capsules have not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation, and the place of manufacture is not approved by the TGA.

TGA investigations have shown that a number of people in Australia may have bought the product online.

Information for consumers

• Stop taking Meizitang Botanical Soft Gel Capsules and take any remaining capsules to your local pharmacy for safe disposal.
• If you have any concerns arising from your use of this product, consult your health care practitioner.

Action the TGA is taking

The TGA is working with the Australian Border Force (ABF) to help stop future shipments of Meizitang Botanical Soft Gel Capsules from entering Australia.

If these capsules are found at the border by the ABF they will be seized and destroyed.

The TGA is advising consumers to exercise extreme caution when purchasing medicines from unknown overseas internet sites and has produced a short video on the risks associated with buying medicines and medical devices online. Products purchased over the internet:

• may contain undisclosed and potentially harmful ingredients
• may not meet the same standards of quality, safety and efficacy as those approved by the TGA for supply in Australia.

Report counterfeit medicines and medical devices

If you are worried about counterfeit medicines or medical devices, and want to report an issue, you can report the matter to the TGA:

Contact details

Phone	1800 020 653
Online:	Report a perceived breach of the Therapeutic Goods Act or questionable practices relating to therapeutic products
Email	info@tga.gov.au

• Category:Alert/Advisory
• Tags:buying online
• URL:https://www.tga.gov.au/node/874449