Click on the links for answers and advice on frequently asked questions for consumers using Traditional Chinese Medicines (TCMs)
1. Do traditional Chinese medicines pose a serious threat to public health?
2. Why is advice being given about the safety of traditional Chinese medicines?
3. What evidence is there of unsafe traditional Chinese medicines on the UK market?
4. What potentially harmful effects can poor quality traditional Chinese medicines have?
5. How many and what proportion of traditional Chinese medicines pose a risk?
6. Do other countries also experience similar problems with traditional Chinese medicines?
7. Don't conventional western medicines lead to many more adverse effects than traditional Chinese medicines?
8. Has anyone besides the MHRA identified problems within the UK?
9. In giving warnings about the safety and quality of traditional Chinese medicines is the Government singling out this particular tradition unfairly?
10. Why doesn't the Government/MHRA give as much publicity to the benefits of traditional Chinese medicines as to the risks?
11. Are the public also at risk from other unlicensed herbal remedies besides traditional Chinese medicines?
12. Are there quality related safety problems with other ethnic medicines such as Ayurvedic remedies?
13. Are the public at risk from western herbal remedies?
14. Aren't herbal medicines safe because they are natural?
15. Is the problem of poor quality controls persistent?
16. Do people taking traditional Chinese medicines need to get medical advice?
17. I am currently taking a traditional Chinese medicine, and I am feeling well. What should I do?/ Should I stop taking traditional Chinese medicines?
18. I am currently taking a traditional Chinese medicine, and I am not feeling well. What should I do?
19. How can I tell which traditional Chinese medicines are safe?
20. If I am worried about a traditional Chinese medicine I am taking how can I find out what is in the remedy? Can I get it tested?
21. How can I tell which traditional Chinese medicine practitioners or clinics are reputable or reliable?
22. Can herbal remedies interact with other medication?
1. Do traditional Chinese medicines pose a serious threat to public health?
The public should be aware that there are some TCM products on the UK market that may be manufactured to low quality standards and may be deliberately adulterated or accidentally contaminated with toxic or illegal ingredients. These products do pose a direct risk to public health and it is not currently possible to distinguish between these products and TCMs that are made to acceptable safety and quality standards.
The shortfall in quality standards does not of course mean that every poor quality TCM is necessarily dangerous, but it does mean that there is an element of risk. The risks vary widely, depending on the ingredients and how they are used.
2. Why is advice being given now about the safety of traditional Chinese medicines?
The former Medicines Control Agency informed the public in 2001 via the general media of the advice given by the Committee on Safety of Medicines (CSM) that it was not possible to give the public assurances as to the safety and quality of TCMs on the UK market. Since then the Agency (now the MHRA) has continued to find examples of illegal and dangerous TCMs being supplied in the UK and consumers should be alerted to the continuing problem.
3. What evidence is there of unsafe traditional Chinese medicines on the UK market?
Recent samples of TCMs found on the UK which pose a risk to public health have contained:
- mercury
- toxic herbal ingredients (typically where a toxic herb has a similar name or similar appearance to the intended ingredient)
- potent prescription only medicines (POM), the safe use of which require supervision by a doctor
- human placenta.
Further details and specific examples of products are included in our herbal safety updates section.
4. What potentially harmful effects can poor quality traditional Chinese medicines have?
The harmful effects of illegal toxic ingredients or inappropriately used potent ingredients can be serious and in some cases life threatening leading for instance to:
- liver damage associated with the use of slimming pills adulterated with the globally banned drug(s) fenfluramine and/ or nitrosofenfluramine. A UK patient has received a liver transplant after taking such a slimming aid called Shubao.
- irreversible kidney failure and cancer as in the case of Aristolochia
- dangerously low blood sugar levels, which can lead to coma and death, due to illegal inclusion of the Prescription Only Medicine Glibenclamide. Glibenclamide is a antihyperglycaemic drug used by doctors to control diabetes.
- thinning of the skin with irreversible changes to the skin structure can be caused by the illegal inclusion of steroids in skin creams. In the long term these creams can worsen eczema and dermatitis that they are used to treat. Since 2002, the MHRA has found steroids in 40% of the skin creams suspected of containing the substances.
- risk of transmitting viruses or bacteria via material such as human placenta.
5. How many and what proportion of traditional Chinese medicines pose a risk?
It is not possible to make an estimate. The nature of poor quality is that problems tend to occur erratically or randomly.
6. Do other countries also experience similar problems with traditional Chinese medicines?
There are extensive examples internationally of public health risks arising from poor standards which shows a substantial global trade in low quality TCMs. Evidence exists that a number of other countries are experiencing similar problems. Problems with Aristolochia in particular have been reported in numerous countries, ranging from Europe, to USA and the Far East. Substantial studies of TCMs in California, Singapore and Taiwan have found significant evidence of adulteration, with undeclared drugs or heavy metals. Earlier this year, Japan reported that 425 people had suffered adverse reactions to TCM slimming aids which were adulterated with fenfluramine and nitrosofenfluramine and had been imported from China. 150 of the patients were hospitalised and four deaths have been reported.
7. Don't conventional western medicines lead to many more adverse effects than traditional Chinese medicines?
For a medicine to get a licence there is first an assessment as to whether the benefits outweigh the risks. If, after licensing, further safety issues emerge the licence can be modified or withdrawn. There are no licensed TCMs in the UK so it is difficult to make a fair comparison with licensed conventional western medicines. The particular problem we are addressing with TCMs is a different one: that inconsistent quality standards in parts of TCM are leading to the public being exposed to uncontrolled risk which on occasions can be serious.
8. Has anyone besides the MHRA identified problems within the UK?
Yes. For example, the problem of illegal and undeclared steroids was covered in the 'British Medical Journal' in February 1999 and 'Which' magazine May 2001. Guy's Medical Toxicology Unit has also found samples containing dangerous ingredients such as heavy metals.
9. In giving warnings about the safety and quality of traditional Chinese medicines is the Government singling out this particular tradition unfairly?
We are responding to specific and unambiguous evidence that quality standards in parts of the UK TCM sector are inconsistent and that this is putting the public at some risk. We would take similar action if the evidence justified it with any other category of products.
10. Why doesn't the Government/MHRA give as much publicity to the benefits of traditional Chinese medicines as to the risks?
It is not the role of the MHRA to advocate the benefits of any unlicensed medicine where, by definition, claims for efficacy have not been put forward for evaluation by the Agency. If an application for a TCM to get a product licence is put forward, the claims for efficacy would be considered on their own merits, as with any other medicine. Likewise an application for a traditional herbal registration would lead to assessment for quality and safety.
11. Are the public also at risk from other unlicensed herbal remedies besides traditional Chinese medicines?
Given the current weakness in the regulatory regime for unlicensed herbal remedies it is likely that quality standards also vary in other traditions besides TCM. However, over the last few years the majority of public health issues identified by the MHRA have related to TCMs.
12. Are there quality related safety problems with other ethnic medicines such as Ayurvedic remedies?
While the majority of safety issues has been identified with traditional Chinese medicines, there are also public health issues over Ayurvedic medicines, particularly over the use of heavy metals. The MHRA investigated the supply of an Ayurvedic product, linked to lead poisoning in a UK patient in 2004. The product reportedly contained lead, mercury and arsenic.
The MHRA have been made aware of at least six cases of heavy metal poisoning in the last 4-5 years associated with the use of Ayurvedic medicines. In most of these cases, the Ayurvedic medicines contained lead. There has also been a case of arsenic poisoning. The Ayurvedic medicines in question were obtained from the Indian sub-continent and brought back to the UK for self use. Patients were treating diabetes, chronic fatigue syndrome and hypertension. In addition reports have been received from authorities in Canada and US.
13. Are the public at risk from western herbal remedies?
Herbal medicines are medicines. Western herbal medicines, as with any other herbal tradition, can have an affect on the human body and should be used with care.
For example, some herbs used widely in western herbal remedies, such as St John's Wort, can interact with prescribed medication (those provided through your doctor or dentist) making them more or less effective. It is important that patients tell their doctor or pharmacist if they are taking a herbal remedy particularly if they are taking them with other medicines such as prescribed medicines or if they are due to have a surgical operation.
14. Aren't herbal medicines safe because they are natural?
Remember that herbal remedies are medicines. As with any other medicine they are likely to have an effect on the body and should be used with care. It is worth remembering that many plants, trees, fungi and algae can be poisonous to humans e.g. Hemlock and Deadly Nightshade. Due to the powerful compounds they contain, many pharmaceuticals have been developed or derived from the plant kingdom including aspirin from willow bark and morphine from the opium poppy.
15. Is the problem of poor quality controls persistent?
It is difficult to accurately quantify the extent of poor quality controls in the unlicensed herbal sector. However, there are reported international examples of poor quality products which illustrate the persistence of the problem.
16. Do people taking traditional Chinese medicines need to get medical advice?
Herbal remedies are medicines. As with any other medicines they are likely to have an effect on the body and should be used with care. Anyone who has previously experienced any liver complaint, or any other serious health complaint is advised not to take any herbal remedy without speaking to their doctor first.
17. I
am currently taking a traditional Chinese medicine, and I am feeling well. What should I do?/ Should I stop taking traditional Chinese medicines?
It is not our intention to stop people taking TCMs. However, we do wish to put the public in a better position to make an informed choice about whether to take such remedies. We believe that the public has a right to know of the safety and quality issues which have arisen with some TCMs. If you decide to take TCMs, our general advice is:
• to be aware of possible risks resulting from poor quality controls; remember that any health risks may be longer term and may not always been seen as immediately obvious adverse effects
• to consult your GP or pharmacist if you have concerns about a particular health problem
• when discussing your health with your GP or pharmacist always mention to them that you are taking herbal remedies
• if you are due to have a surgical operation you should always remember to tell your doctor about any herbal remedy that you are taking.
18. I am currently taking a traditional Chinese medicine, and I am not feeling well. What should I do?
If you think that you may have suffered an adverse reaction to a herbal remedy you should discontinue use and tell your doctor or pharmacist.
If you think that a particular TCM may have led to a health problem, the best advice is to keep any of the product remaining and discuss the problem with your GP or pharmacist. The GP or pharmacist can then consider whether to submit a report to the MHRA under the Yellow Card Scheme.
If you wish to know more about safety issues associated with herbal medicines please see our herbal safety updates section.
19. How can I tell which traditional Chinese medicines are safe?
There is no entirely reliable way of doing so at present. Absence of labelling in English indicates a cause for concern. However, clear labelling of contents itself is not a guarantee of safety and quality. The MHRA has come across products labelled with ingredients which are clearly illegal in unlicensed medicines. The Agency has also found the inclusion of illegal ingredients in TCMs which are not declared on the label.
Any safety concerns the MHRA may have are highlighted in our Herbal safety updates section.
NEEDS UPDATING - re new practioner policy from DH.
20. If I am worried about a traditional Chinese medicine I am taking how can I find out what is in the remedy? Can I get it tested?
The person supplying the remedy should be able to tell you what is in the remedy. If he or she is unwilling or unable to tell you, that may suggest a need for caution. Generally speaking, testing a remedy will not answer the open question: what is in this remedy. However, remedies can be tested for the presence of certain ingredients. The United Kingdom Accreditation Scheme for analytical laboratories produce a directory of accredited labs and the tests for which they a re accredited. If you think that a particular TCM may have led to a health problem, the best advice is to keep any of the product remaining and discuss the problem with your GP or pharmacist. The GP or pharmacist can then consider whether to submit a report to the MHRA under the Yellow Card Scheme.
If you wish to know more about safety issues associated with herbal medicines please see our herbal safety updates section.
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21. How can I tell which traditional Chinese medicine practitioners or clinics are reputable or reliable?
There is no entirely reliable way of doing so. However, various practitioner and trade associations operating in the sector follow codes of conduct. You may find it helpful to ask which body they belong to and what are the requirements for membership of that body. Questions which might be asked about products include: what arrangements are made to ensure that products are legal, safe and of acceptable quality? What steps are taken to ensure that labelling is accurate? What are the arrangements if you wish to make a complaint?
22. Can herbal remedies interact with other medication?
Herbal remedies may sometimes interact with other medicines making these medicines more or less effective. This makes it particularly important to tell your doctor or pharmacist if you are taking a herbal remedy with other medicines such as prescribed medicines (those provided through your doctor or dentist). You should continue to take any medication prescribed by your doctor.
