Privileged Statement - Chinese medicines withdrawn
14 February 2003
Director-General's Privileged Statement Under Section 98 Of The Medicines Act 1981
Two Chinese medicines being sold as herbal remedies are being withdrawn because they illegally contain pharmacy-only medicines, says Director-General of Health Dr Karen Poutasi.
Last month the Ministry of Health's medicines safety authority (Medsafe) ordered the withdrawal of 11 Chinese medicines sold as herbal remedies after testing revealed they contained scheduled medicines and toxic substances.
Medsafe has ordered more testing after it found two of those products had been misidentified in information provided to the Ministry.
Gan Mao Tong was misnamed as Sang Ju Gan Mao Pian tablets, while Shu Xiao Shang Feng was misnamed as Yen Qiao Jie Du Pian capsules. These products were ordered for withdrawal because they contain pharmacy-only medicines while being sold under the guise of herbal remedies.
The correct name for Yen Qiao Jie Du Pian is Yin Qiao Jie Du Pian. New testing has found Yin Qiao Jie Du Pian contain no scheduled medicines but the product remains withdrawn because it is in breach of labelling requirements of the Medicines Act 1981. Medsafe is trying to obtain samples of Sang Ju Gan Mao Pian for testing.
Problems with misnaming these products has been exacerbated by labelling being predominantly in Chinese and in some cases failing to list ingredients, which is in breach of labelling law.
"The wrongly translated names were provided to Medsafe by the practitioner whose products we took for testing. We regret the error, however, both Gan Mao Tong and Shu Xiao Shang Feng are in breach of legislation by containing pharmacy-only medicines while being marketed and sold as herbal remedies," says Dr Poutasi.
She says the practitioner who misnamed the products was selling strips of tablets/capsules without packaging, which contributed to the misnaming.
The products now being ordered for withdrawal are:
Gan Mao Tong - found to contain 21mg Diclofenac (a non steroidal anti-inflammatory) per tablet and about 1mg Chlorpheniramine (an antihistamine). These are pharmacy only medicines and apart from requiring consent from the Minister of Health before they can be sold, can only legally be sold from pharmacies.
Shu Xiao Shang Feng - which contains 3mg Chlorpheniramine, 0.056mg Diclofenac per capsule and about 450mg Paracetamol (pain reliever).
Yin Qiao Ji Du Pian - it remains withdrawn as its labelling is predominantly in Chinese, fails to list ingredients in English and makes therapeutic claims.
Dr Poutasi says the Ministry will be alerting importers and distributers of traditional Chinese medicines to cease distribution and sale of these products, and withdraw them from retail outlets they may have supplied.
Since January's notice of withdrawal, five other products which are being marketed as Chinese medicines are being tested by the Institute of Environmental Science and Research (ESR). Full results from all tests are expected in a week.
"All the products identified for withdrawal in January breach labelling legislation. Anyone who cannot read Chinese language would be purchasing these products believing them to be herbal," says Dr Poutasi.
"As mentioned last month, Medsafe advised importers and sellers of Chinese medicines to obtain assurances from manufacturers that the products they import are made to acceptable international standards and contain no scheduled medicines. We know many Chinese traditional medicine practitioners operate within the law, so it's unfortunate for that profession when a few choose to flout it.
"The risks to the unsuspecting public from purchasing and taking these products are increased when products marketed as Chinese medicines or Chinese patent medicines are labelled entirely in Chinese, exacerbating the problem of identifying ingredients. The dietary and herbal supplement industry is not well-regulated which is all the more reason why proposed legislation aims to ensure the safety and quality of these products.
"It's extremely concerning that these products entered the country and were sold to the public without any prior checks for safety and quality. The proposed new regulatory regime will have minimum requirements to ensure that such products do not get on the market without being registered and giving assurances of their safety and quality."
The other nine products which remain ordered for withdrawal are:
* Guan Xin Su He capsules; Long Dan Xie Gan Wan pills; Zhiyuan Xinqinkeli sachets - all contain aristolochic acid. Has been linked overseas to severe kidney damage and urinary tract cancer.
* Wei Ge Wang tablets - contain prescription medicine sildenafil. Viagra, is the only brand of sildenafil legally sold here. Sildenafil is known to interfere with some heart medication and could be fatal to some individuals.
* Niu Huang Jie Du Pian tablets - contain 4% arsenic.
* Xiaoke Wan pills - contain Glibenclamide (an antihyperglycaemic) 2.5mg per 10 pills.
* Shuen Feng cream - contains Ketoconazole (an antifungal ) and Clobetasol Proprionate (a cortcosteroid, which controls skin inflammation).
* Zentel Albendazole SK&F tablets - contain Albendazole 200mg per tablet.
* Dezhong Rhinitis drops - contain ephedrine hydrochloride.
Dr Poutasi says consumers can take the following steps to minimise the risks from consuming products containing prescription, pharmacy-only medicines or toxic substances: - ensure they are aware of all the ingredients of any herbal remedy they take - check with a healthcare provider or medical practitioner that the herbal remedy will not interfere with any other medication they may be taking - only buy products that have all ingredients listed on the product, in a language they are able to understand, or which has been accurately translated - seek assurance from suppliers, importers and manufacturers of the products that they are safe and do not contain aristolochia
For more information, and photographs of these products, see websites: www.moh.govt.nz/media/recall and www.medsafe.govt.nz/hot.htm
Or contact: Kim Purdy Media Advisor Government & Sector Relations\Communications Corporate & Information Directorate Ministry of Health DDI: 04 496 2483 Mobile: 025 277 5411 Fax: 04 496 2010
What are the products ordered for withdrawal? Guan Xin Su He capsules; Long Dan Xie Gan Wan pills; Zhiyuan Xinqinkeli sachets: contain aristolochic acid. Use of products containing aristolochic acid have been associated with acute renal failure and the development of urinary tract cancers. Although it is a prescription-only medicine in New Zealand it is not prescribed for any known conditions. Further information on the toxicity of aristolochia can be found on the Medsafe website: www.medsafe.govt.nz/hot.htm Wei Ge Wang tablets: contain prescription medicine Sildenafil. Viagra, is the only brand of sildenafil legally sold here and is used for managing male impotence. Sildenafil is known to interfere with some heart medication and could be fatal to some individuals. Gan Mao Tong (incorrectly named as Sang Ju Gan Mao Pian): contain approximately 1mg Chlorpheniramine (an antihistamine) and 21mg Diclofenac (a non steroidal anti-inflammatory) per tablet. This product is being sold for cold and flu symptoms. Shu Xiao Shang Feng (incorrectly named as Yen Qiao Jie Du Pian): contain about 450mg Paracetamol ( pain reliever), 3mg Chlorpheniramine ( antihistamine) and 0.056mg Diclofenac per capsule. This product is being sold for cold and flu symptoms. Niu Huang Jie Du Pian tablets: contain 4% arsenic, a prescription medicine. This is being sold for mumps, sore throat and tonsillitis. Xiaoke Wan pills: contain Glibenclamide (an antihyperglycaemic) 2.5mg per 10 pills, a prescription medicine. This is being sold for diabetes. Shuen Feng cream: Contain prescription medicines Ketoconazole (an antifungal ) and Clobetasol Proprionate (a cortcosteroid, which controls skin inflammation). This is being sold for fungal skin infections. Zentel Albendazole SK&F tablets: Contains prescription medicine Albendazole 200mg per tablet. This is being sold for worm infestations. Dezhong Rhinitis drops: Contain prescription medicine ephedrine hydrochloride. This is being sold as a nasal decongestant.
What product that was misnamed has been cleared of containing scheduled medicines? Test showed Yin Qiao Jie Du Pian is an entirely herbal product. Sang Ju Gan Mao Pian was also misnamed but no sample is available yet for testing.
Why have products containing aristolochic acid been recalled? Because of its potential danger to public health. Overseas evidence has linked aristolochia to severe kidney damage and urinary tract cancer. In Belgium, 70 people taking a herbal remedy containing aristolochia had renal failure requiring renal dialysis and, in some instances, kidney transplants. Other countries that have registered concern about aristolochic acid include Australia, Canada, Singapore, Belgium, United Kingdom and the USA.
How many people take it in NZ? There is no reliable information about how many people take these products but it is possible that some users of Chinese medicines may have taken aristolochia.
Where has aristolochia been found? The following herbs are at risk of substitution with aristolochia species, and may be described as mu tong or fang ji (a combination of herbs likely to include aristolochia). The herbs are: Akebia, asarum, bragantia, clematis, cocculus, diploclisia, menispernum, saussurea, sinomenium, stephania and vladimiria.
The following products may have mu tong or fang ji as declared ingredients and may contain aristolochia: Ba Zheng Wan, Chun Yang Zheng Ji Wan, Da Huang Qing Wei Wan, Dang Gui Si Ni Wan, Dao Chi Wan, Dieda Wan, Fu Ke Fen Quing Wan, Ji Sheng Ju He Wan, Kat Kit Wan, Quell Fire, Shi Xiang Fan Shen Wan and Xin Yi Wan.
The following products have been tested in Australia and found to contain aristolochic acids: Ba Zheng San Pills and Chuan Xiong Cha Tiao San Pills (Lanzhou Taibao Medicines Factory China, Cathay Wholesale Pty Ltd); Mu Tong Akebia 5407 & Radix Stephania tetrandra and Sun-Ten Hoelen &Schizandra Combination Granules (Sun Ten Pharmaceutical Co, Taiwan, Sun Ten Chinaherb Co P/L); Tong Ren Tang Longdan Qiegan Wan "Wetness Heat" Pill (China Beijing Tong-Ren-Tang Australian Company Pty Ltd); Xiao Feng San Pills and Xiao Qing Long Wan Pills (Lanzhou Taibao Medicines Factory China, Cathay Wholesale Pty Ltd); Xiao Qing Long Wan Pills (Shen Neng Pty Ltd); Xin Yi San Pills and Xuan Bi Tang Pills (Lanzhou Taibao Medicines Factory China, Cathay Wholesale Pty Ltd). Note: Many products may not have information in English on the packaging and the names listed above may be English translations of the Chinese labels.
What are health concerns related to sildenafil? The safety of sildenafil is uncertain in patients with: severe hepatic impairment (liver disease), bleeding disorders (eg haemophilia), active peptic ulceration (stomach ulcers), hypotension (low blood pressure), hypertension (high blood pressure), recent history of stroke or myocardial infarction (heart attack), unstable angina (heart pain), heart failure, known hereditary degenerative retinal disorders (eye disease). Sildenafil should never be used by patients on nitrate medication (used for prevention of angina) as the interaction between the two medicines can be potentially fatal.
Why was it tested and what are the ingredients? Wei Ge Wang (Jiu Bian Li - the company name on the reverse side of the tablet foil) was tested because of its similar appearance to Viagra. It is a blue-coloured diamond shape tablet in packs of four with VG inscribed on the tablet, apparently suggested for use in male impotence. Ingredients are written on the packet in the Chinese language. They include goat penis, ox penis, dog penis, deer penis, seal penis, ginseng and traditional Chinese herbal medicines. Note: sildenafil is not listed as an ingredient on the package.
Who is responsible for recalling the eleven products? Distributors and importers are required to recall the products, and have been given advice on how to manage these returns.
How do consumers know what the products contain? Most of the information printed on the packaging is in the Chinese language and not all ingredients are always listed. Usually the only way to be certain about what is present is by having the product tested. To be confident about what they are taking consumers should only buy products that have all the ingredients accurately listed on the product, in a language they are able to understand, or which has been accurately translated. Consumers should seek assurance from suppliers that the medicines they are purchasing are safe and do not contain other medicines.
If people are taking any of these products what should they do? Stop taking them immediately and seek medical advice.
Can the eleven products be sold in the interim? No. Distributors and importers are responsible for ensuring products they import or sell do not contain aristolochic acid or any other prescription medicines. Also, it is illegal to provide prescription medicines without a prescription from a registered medical practitioner. Dietary supplements and herbal remedies are not regulated, which concerns Medsafe. Under food and medicine legislation they should list all ingredients on packaging, write all information on packaging in the English language and include the percentage of active ingredients. Ensuring consumers only have access to herbal remedies and dietary supplements that are safe is a difficult task and one faced by other governments. The Ministry of Health is working with Australia on long term solutions (see below). In the interim Medsafe will be considering options for preventing products contaminated with aristolochic acid from entering New Zealand.
What can be done in the long term to reduce the risk from herbal remedies? Under proposed new legislation, a joint therapeutic products agency will improve the quality and safety of dietary supplements and herbal remedies.
Currently the safety and quality of dietary supplements and herbal remedies are not regulated. This means that the Government and consumers cannot be certain that: ? The ingredients of the dietary supplements or the products themselves are safe and effective; and ? Adequate steps have been taken to ensure product quality ? for instance, that products contain only the stated ingredients in the quantities specified on the label, and that they are free from contamination with micro-organisms, heavy metals and so on.
It is well recognised that in herbal medicine isolating and concentrating a particular constituent of a plant can produce a substance more hazardous than the herb from which it was extracted. Safety of ingredients is, therefore, an important issue for complementary healthcare products. In addition, problems can arise with these products when there are not sufficient quality checks during the manufacturing process. Regulation would ensure that manufacturers have quality systems in place in their factories. This will help reduce contamination and ensure products are effective to the end of their shelf life.
Under the proposed new legislation, all products represented to be for a therapeutic purpose would be regulated according to the risk associated with their use. The regulatory controls applied to most complementary healthcare products would be less stringent than those applied to prescription medicines, in recognition of the different levels of risk. Due to their relatively low risk, most dietary supplements in New Zealand would continue to be available from herbalists, supermarkets, health food stores and other retail outlets.