Revised: 14 May 2013
Publications
Media Releases for 2003
10 December 2003
Australia and New Zealand sign treaty to regulate medicines and therapeutic products
17 November 2003
Ministry of Health Strengthens Warnings over use of HRT
The Ministry of Health has strengthened its caution to health professionals and women about the use of hormone replacement therapy. This follows a review of recent studies clarifying the risks associated with use of these medicines.
The new advice leads on from earlier statements made by the Medicines Adverse Reactions Committee, MARC, which is an independent expert advisory committee on medicines safety. The advice is:
- Women should be advised of the risks associated with use of hormone replacement therapy (HRT) before treatment begins. Including information that use of HRT is associated with increased risk of developing blood clots in the veins of the legs and in the lungs (pulmonary embolism), stroke (bleeding or blood clot in the brain) and breast cancer. These risks exist for all forms of HRT and increase with duration of use. While the increased risk of developing a blood clot appears within a few weeks of starting treatment, other risks only become evident after longer use, with the increased risk of developing breast cancer appearing after 1-2 years use of HRT. Many of the risks associated with use of HRT also increase with age and for women aged 65 or older HRT use is associated with an increased risk of dementia.
- Due to the publication of the Million Woman study which showed that the increased risk of breast cancer appears within 1-2 years, the MARC now recommend that where HRT is prescribed, it should be taken at the lowest dose for the shortest period of time. The need for continuing treatment should be reviewed six-monthly.
- HRT should no longer be used for the primary or secondary prevention of cardiovascular disease (heart attack or stroke). It remains an appropriate treatment only for women with moderate to severe menopausal symptoms such as hot flushes and sweats.
"Two new studies examining the safety of HRT have provided important new information about the safety of both combined HRT and oestrogen-only HRT since the Medicines Adverse Reactions Committee issued advice in September 2002," said Medsafe's Principal Advisor, Dr Stewart Jessamine.
A large scale US based study of 16,000 women, The Women's Health Initiative Memory Study (WHIMS), further discredited use of HRT in older women when it found combined HRT doubled the risk of developing dementia. The study estimated that use of combined HRT in women aged 65 years and over would produce an extra 23 cases of dementia per 10,000 women per year, with the increased risk becoming noticeable after one year of combined HRT treatment.
An extremely large study in the United Kingdom, The Million Women Study,
presented significant new information including:
- the risk of breast cancer is seen within one to two years of commencing
HRT and increases with duration of use,
- all forms of HRT are associated with an increased risk of developing breast
cancer,
- the risk of breast cancer decreases after stopping HRT, and within five
years the residual risk is not significantly different from that observed
for women who have never used HRT.
Dr Jessamine said "The risk of developing breast cancer associated with HRT use is relatively small, causing an additional 6 breast cancers per 1000 women after 5 years use of HRT. However, in the opinion of the MARC, the studies all demonstrate that the risks of HRT treatment outweigh the benefits for everything other than for short-term use to relieve moderate to severe symptoms caused by the menopause. The new evidence supports the conclusion that if HRT is required, it should be used for the shortest period of time possible. Prescribers should be actively monitoring patients on HRT a minimum of every six months to make sure ongoing treatment is really necessary."
For more information contact:
Antony Byers
Media advisor
Ministry of Health
DDI: 496 2115
Mobile: 027-434-6878
https://www.health.govt.nz/news-media
mailto: antony_byers@health.govt.nz
QUESTIONS AND ANSWERS
What risks did the studies show?
Table 1. Number of additional breast cancers from HRT use (compared to no HRT use) per 1000 women by age 65 from The Million Women Study.
| Type of HRT | Duration of HRT use (from age 50) | |
|---|---|---|
| 5 years | 10 years | |
| Oestrogen-only | 1.5 | 5 |
| Combined oestrogen-progestogen | 6 | 19 |
Table 2. Summary of incidence of adverse events based on results from the WHI study. Data derived from women aged 50 to 79 years, after an average follow-up of 5.2 years.
| Adverse Event | Change in number of adverse events per 10,000 women in one year |
|---|---|
| Breast cancer | 8 extra |
| Heart disease | 7 extra |
| Stroke | 8 extra |
| Pulmonary embolism | 8 extra |
| Colorectal cancer | 6 fewer |
| Hip fracture | 5 fewer |
How is this advice different from the previous advice?
The new advice says the need for continuing treatment should be reviewed six-monthly, and HRT should be taken at the lowest dose for the shortest period of time. The September 2002 advice said HRT should be reviewed at the time of the next prescription.
How significant are the risks?
The absolute risk of developing breast cancer, heart disease, stroke and pulmonary embolism associated with HRT use is small (31 extra cases per year in 10,000 women over 50 years of age using HRT long term). Note these are cases, not deaths.
What are the increased risks of dementia?
Combined HRT doubled the risk of developing dementia, which would result in an extra 23 cases of dementia per 10,000 women per year.
What are the benefits of HRT?
The therapy can alleviate symptoms of menopause including hot flushes, and sweats. The studies showed that HRT was protective for colorectal cancer and hip fracture (11 fewer cases per year per 10,000 women over 50 years of age using HRT long term).
How does it work?
The body's production of two hormones decreases when a woman reaches menopause. Those hormones are oestrogen and progestogen and the replacement therapy aims to replace one or both of those hormones.
How is it administered?
In New Zealand, most women take HRT in tablet form. A very few use patches.
If I'm concerned, what should I do?
Talk with your doctor about whether you should continue with HRT. If a decision is made to stop HRT it should be withdrawn gradually. Information on how to reduce HRT can be found in the 2002 HRT Guideline Updateon the New Zealand Guidelines Group website: www.nzgg.org.nz
Where can I find information about this advice and the studies it refers to?
www.medsafe.govt.nz/profs/PUArticles/HRT2003.htm
3 October 2003
Medsafe Removes Restrictions on Felo ER 5 and 10mg
On 5 November 2002, Medsafe asked Pacific Pharmaceuticals to withdraw Felo ER from the NZ market after concerns about the quality of the data supporting the original approval of the Felo range of products emerged in Europe.
At Medsafe's request, Pacific Pharmaceuticals supplied Medsafe with a new information pack supporting the safety and efficacy of the range of Felo products. Medsafe has assessed these data and is now satisfied that Felo ER 5mg and Felo ER 10mg meet the safety, quality and efficacy standards required for marketing generic medicines in New Zealand. The prohibition on the distribution of Felo ER 2.5mg tablets however, will remain in place until additional safety and efficacy data for this product are supplied.
Medsafe have informed Pacific Pharmaceuticals that it can once again distribute Felo ER 5 and 10mg tablets; and these two products will be added to the Interchangeable Multisource Medicines List (IMM).
27 May 2003
Women's Health initiative Memory Study
The Ministry of Health said today that results from the Women’s Health Initiative Memory Study (WHIMS) further supports the hormone replacement therapy (HRT) advice issued to New Zealanders last year.
The study, released today, indicates an increase in the risk of probable dementia associated with use of HRT in women aged 65 years and over.
Ministry spokesman Dr Stewart Jessamine said the Medicines Adverse Reactions Committee (MARC) and New Zealand Guidelines Group put out advice in September 2002 which clearly stated to practitioners that use of oestrogen and progestogen as hormone therapy should be limited to the early menopause for a limited time, and only where symptoms are disruptive to the woman's quality of life.
The Ministry recommended in September last year that all women on HRT should be reviewed at the time of their next prescription to determine why they are using HRT and be advised of the risks and benefits of continued therapy so they could make an informed choice.
In view of the WHIMS study results and another recent WHI ancillary study which failed to demonstrate any evidence of improved quality of life in women taking combined hormone therapy, Dr Jessamine said the Ministry of Health wished to reiterate the MARC advice.
"The WHIMS and WHI Quality of Life studies provide further evidence that in most circumstances the risks of long-term treatment with oestrogen and progestogen outweigh the benefits. Women on combined hormone therapy should be reviewed at yearly intervals to determine if treatment is still required and in most circumstances combined hormone therapy should not be used for longer than three to four years."
The Medicines Adverse Reactions Committee will review the most recent publications of results from the WHI and WHIM studies at its June meeting and determine if any further action limiting use of hormone therapy is required.
"In the interim, the WHIMS report provides practitioners with a further reason to review women on oestrogen and progestogen hormone therapy and discuss whether continuing treatment is appropriate," Dr Jessamine said.
"It is interesting to note figures from Pharmac show that since the middle of last year, the number of women on HRT has dropped by 36 percent. This shows that health practitioners and women are reviewing their options, as suggested in the advice released by the Ministry, the MARC and the Guidelines Group.
"However, there could still be women in New Zealand aged 65 years or older who may still be on combined hormone therapy. In light of these results they should visit their GP to talk through this new evidence and determine whether it is appropriate to continue hormone therapy."
Dr Jessamine said: "The WHIMS only examined the effects of combined hormone treatment on memory loss in women older than 65 years, and the results cannot be assumed to apply to younger women taking combined hormone therapy.
"The Ministry will be discussing the WHI ancillary studies, and other published research, with the MARC, to determine if there is sufficient evidence available to draw any conclusions on whether combined hormone treatment poses any risks of memory loss or dementia in younger women."
Note: The MARC and Guidelines Group advice was distributed by Medsafe to every doctor and pharmacy in the country. (Copies of both documents are available on the Medsafe website at www.medsafe.govt.nz/hot/contraceptives.asp). In addition, Prescriber Update - a Medsafe publication written for doctors, pharmacists and other health professionals - carried articles and advice on HRT in its November 2002 edition.
Background
The Women's Health Initiative (WHI) study, stopped in June last year due to evidence of increased risk of cardiovascular disease and breast cancer in women using combined oestrogen and progestogen hormone therapy, also contained several ancillary studies. This Women’s Health Initiative Memory Study (WHIMS) is one of these ancillary studies. The WHIMS was designed to determine if use of hormone therapy reduced the risk of a woman developing dementia or mild cognitive impairment.
WHIMS recruited 4894 women aged 65 years or older who were already participating in the WHI study. Following recruitment into the WHI and WHIMS studies the women were randomised to either active medication (ie containing oestrogen and progestogen or oestrogen on its own), or placebo treatment.
The women were then followed annually for the next four to five years and administered a series of tests of mental function to determine if any signs or symptoms of cognitive impairment, (memory problems) or dementia occurred.
To minimise the risk of introducing bias, the technicians and clinicians assessing the participants for signs of memory impairment or dementia followed strict protocols for assessing the patients and were blinded to the study medication being taken by the patient.
The results of the WHIMS released today indicate that women aged 65 or over who take oestrogen and progestogen were approximately twice as likely to be diagnosed as having probable dementia than women taking placebo.
While the risk was doubled, the actual increase in frequency of diagnosis of dementia associated with use of oestrogen and progestogen is relatively small.
About 10 percent of women aged older than 65 years are diagnosed as having Alzheimer’s disease. The WHIM data indicates use of combined hormone therapy in women aged 65 years and above without pre-existing dementia increases the risk of the diagnosis of dementia being made from 22 per 10,000 women years to 45 per 10,000 women years. The increased risk of dementia remained after the data was re-examined and recalculated, taking into account other factors that may predispose the women in the study to dementia, such as smoking history, or history of vascular disease.
The WHIMS data shows no difference in the frequency of mild memory loss between the groups of women taking active treatment with combined hormone therapy and those taking placebo. The underlying mechanism for oestrogen and progestogen increasing the risk of being diagnosed with probable dementia is not known.
The WHIM study did not examine the effects of hormone treatment on memory, or risk of dementia in women younger than 65 years.
ENDS
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 is 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
ENDS
For more information, and photographs of these products, see websites: www.health.govt.nz/news-media/media-releases and Photos of Traditional Chiense Medicines
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
www.health.govt.nz
mailto:kim_purdy@health.govt.nz
Background
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.
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.
ENDS
21 January 2003
Director-General's Privileged Statement Under Section 98 of The Medicines Act 1981
Director-General of Health Dr Karen Poutasi is today warning people to stop taking eleven traditional Chinese medicines sold as herbal remedies after investigation and testing revealed they contain prescription medicines and toxic substances.
The Ministry of Health's medicines safety authority (Medsafe) is ordering the withdrawal of three traditional Chinese medicines containing the herb aristolochia, which can cause kidney damage and urinary tract cancer.
A number of other traditional Chinese medicine products containing prescription medicines including sildenafil, ephedrine and arsenic, are being withdrawn.
Products to be withdrawn 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.
- Gan Mao Tong Sang Ju Gan Mao Pian tablets - contain 21mg Diclofenac (a non steroidal anti-inflammatory) per tablet and about 1mg Chlorpheniramine (an antihistamine). These are pharmacy-only medicines and are illegal to be sold at outlets other than pharmacies.
- Shu Xiao Shang Feng Yen Qiao Jie Du Pian capsules - contain 3mg Chlorpheniramine, 0.056mg Diclofenac per capsule and about 450mg Paracetamol (pain reliever). The following five products contain prescription medicines:
- 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 people using any of the 11 products should immediately stop taking them and seek medical advice from their GP.
The products were discovered following an investigation into a complaint to Medsafe about a Chinese herbal medicine. Testing was carried out by either the Therapeutic Goods Administration in Australia (TGA) or the Institute of Environmental Science and Research (ESR) in New Zealand.
Medsafe has written to the importers and distributors of traditional Chinese medicines requesting they cease all distribution and sale of these products, and withdraw them from retail outlets they may have supplied. They have also been asked to ensure other products they sell do not contain any scheduled medicines.
Medsafe has also written to all general medical practitioners alerting them to these products, outlining risks associated with their use and providing advice on appropriate management of people who have taken them.
Dr Poutasi says there have been no reported cases of kidney damage or urinary tract cancers associated with aristolochia reported in New Zealand. However, she says in some cases individuals who have taken aristolochia may show no symptoms and should check with their GP to be sure.
"People taking these products should exercise caution and if they have any health concerns, they should contact their GP."
It is impossible to be certain herbal remedies do not contain prescription medicines without testing. Dr Poutasi says it's important consumers are cautious as there may be more Chinese herbal products at risk of containing prescription medicines or toxic substances.
However, the following steps may help minimise the risks from consuming products containing aristolochia, sildenafil or any other prescription medicines.
Consumers should:
- ensure they are aware of all the ingredients of any herbal remedy they take
- check with a 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
Dr Karen Poutasi
Director-General
NOTE: photographs of these products and copies of Medsafe's letter to registered GPs, are available on www.health.govt.nz/news-media/media-releases and www.medsafe.govt.nz/hot/alerts/HerbalChineseMed/DocLtr.htm
For further information 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
www.health.govt.nz/news-media
www.medsafe.govt.nz/safety/AlertsArchive.asp
mailto: kim_purdy@health.govt.nz
Questions and Answers
What are the products being withdrawn?
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 Sang Ju Gan Mao
Pian tablets: 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 Yen Qiao
Jie Du Pian capsules: 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.
Photographs of the withdrawn
products
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 traditional 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.
