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Collected Abstracts: Patent Medicines

But PP. Herbal poisoning caused by adulterants or erroneous substitutes. J Trop Med Hyg 1994 Dec;97(6):371-374
Abtract:  Six cases of herbal poisoning involving six patients in Hong Kong, Taipei and Kuala Lumpur are reported. The sources of poisoning were identified as adulterants (Podophyllum emodi) or erroneous substitutes (Datura metel). In cases of suspected herbal poisoning, it is recommended that the prescriptions, herbal residues and herb samples should be collected for pharmacognostical and chemical analysis to substantiate the cause of poisoning. Insofar as it is possible, an estimate of the amount of herbs consumed should also be obtained, to establish whether the amount of toxin present is sufficient to account for the symptoms.

Chan TY, Critchley JA.  Usage and adverse effects of Chinese herbal medicines. Hum Exp Toxicol 1996 Jan;15(1):5-12
Abstract:  The great majority of Chinese herbal preparations are safe, and in the past, some useful Western drugs have been derived from these herbs. Nearly all serious poisonings are due to the few preparations containing aconitine, podophyllin or anticholinergics or else proprietary preparations containing dangerous Western drugs or heavy metals. Both medical professionals and the general public should be alerted to the potential toxicity of herbal remedies. There should be frequent monitoring of Chinese herbal medicines or their derivatives, such as some Chinese proprietary medicines, for undeclared Western drugs and heavy metals. Mothers should be discouraged from treating their children with herbal or proprietary medicines. There should be continuing efforts to collect safety information on these widely used products.

Publication Types:

  • Review
  • Review, tutorial

Chan TY, Lee KK, Chan AY, Critchley JA. Poisoning due to Chinese proprietary medicines. Hum Exp Toxicol 1995 May;14(5):434-436
Abstract:  1. To determine the toxic potentials of those Chinese proprietary medicines (CPM) which are commonly used for self-poisoning by adults in Hong Kong, all patients admitted to four of the eight general medical wards at the Prince of Wales Hospital between January 1988 and December 1993 were retrospectively studied. 2. There were 54 women and 17 men with their age ranging from 15 to 86 years. Twenty-three subjects (32%) also took alcohol, chemicals or drugs. Of the 51 subjects (72%) who had taken topical medicaments, 22 had no symptoms while 28 had minor features of gastrointestinal irritation (n = 26), mild (n = 2) or severe (n = 1) salicylate poisoning. Of the 17 subjects (24%) who had taken CPM tablets/capsules, nine had mild symptoms including nausea/vomiting and drowsiness. The three remaining patients (4%) who had ingested liquid CPM preparations were asymptomatic. Elevated plasma salicylate or paracetamol concentrations (> 0.1 mmol l-1) were found in some patients who had taken topical medicaments and CPM tablets/capsules, respectively. All the 71 patients completely recovered. 3. Most of the CPM used for self-poisoning in Hong Kong were of low to moderate toxicity except for those containing wintergreen oil (methyl salicylate).

Chan TY, Tomlinson B, Tse LK, Chan JC, Chan WW, Critchley JA.  Aconitine poisoning due to Chinese herbal medicines: a review. Vet Hum Toxicol 1994 Oct;36(5):452-455
Abstract:  Both "chuanwu", the main root of Aconitum carmichaeli, and "caowu", the root of A kusnezoffii, are believed to possess anti-inflammatory, analgesic and cardiotonic effects and have been used in Chinese materia medica mainly for the treatment of musculoskeletal disorders. They contain the highly toxic C19 diterpenoid alkaloids of aconitine, mesaconitine and hypaconitine. After ingestion, patients may present with signs and symptoms that are typical of aconitine poisoning. Death may occur from ventricular arrhythmias, which are most likely to occur within the first 24 h. Management of aconitine poisoning is essentially supportive. There are no adequate studies in humans to indicate the most effective treatment of the ventricular arrhythmias. All clinicians should be alerted to the potential toxicity of "chuanwu" and "caowu".

Publication Types:

  • Review
  • Review, tutorial

Chan TY.  The prevalence use and harmful potential of some Chinese herbal medicines in babies and children. Vet Hum Toxicol 1994 Jun;36(3):238-240
Abstract:  This article reviews the prevalence use of Chinese herbal medicines (CHM) in Chinese pregnant women, babies and children living in Hong Kong and the harmful potential of some CHM and Chinese proprietary medicines (CPM) in babies and children. The use of CHM appears to be common amongst Chinese pregnant women. The possible effects of these herbs on the fetus and baby and their overall safety are not known. This practice should be discouraged since there is suggestion that maternal consumption of CHM might increase the risk of neonatal jaundice. Both "chuen-lin" and "yin-chen" can displace bilirubin from their serum protein binding and increase the risk of hyperbilirubinaemia. These herbs should not be given to the neonates. The use of CPM-containing undeclared drugs of high toxicity or lead, arsenic and mercurial compounds should be banned. The medical profession and the general public should be alerted to the harmful potential of some of the CHM and CPM. There should be continuing efforts to collect information on the safety of these compounds.

Publication Types:

  • Review
  • Review, multicase

Chan TY, Tomlinson B, Critchley JA.  Aconitine poisoning following the ingestion of Chinese herbal medicines: a report of eight cases. Aust N Z J Med 1993 Jun;23(3):268-271
Abstract:  BACKGROUND: Traditional Chinese medicines often contain 'chuanwu' and 'caowu', the roots of certain Aconitum species which are thought to have an anti-inflammatory effect in many conditions. Excessive amounts of these materials, which contain diterpene alkaloids particularly aconitine, can produce toxic effects and occasional fatalities. AIMS: This study was conducted to document the adverse effects related to these herbal medicines which resulted in hospital admission and to determine the outcome in these patients. METHODS: A retrospective survey was conducted of patients admitted to the Prince of Wales Hospital, Hong Kong with suspected adverse effects from Chinese herbal medicines containing chuanwu or caowu over a two year period from 1989 to 1991. RESULTS: Eight patients were identified with features of mild to moderate intoxication including nausea and vomiting, paraesthesiae or numbness in the mouth and extremities, hypotension and ventricular extrasystoles. The management of aconitine poisoning is essentially supportive and in-hospital observation with ECG monitoring should be continued for at least 24 hours because of the risk of cardiovascular collapse and ventricular arrhythmias. The medical profession and general public should be alerted to the potential toxicity of these herbs and their usage should be controlled by legislation in Hong Kong as it is in some other countries.


Chan TY, Chan JC, Tomlinson B, Critchley JA.  Chinese herbal medicines revisited: a Hong Kong perspective Lancet 1993 Dec 18-25;342(8886-8887):1532-1534
Abstract:  Chinese herbal medicines (CHM) and Chinese proprietary medicines (CPM) are widely used by people of Chinese origin throughout the world. Although the use of these medicinal materials rarely causes significant toxic effects, cases of severe and even fatal poisoning have occurred after medication with herbs containing aconitine, podophyllin, and anticholinergic substances. Furthermore, CHM and CPM are often adulterated with substituted herbs, heavy metals, and western medicines; such contamination can have important clinical consequences. In Hong Kong, surveillance and legislation are required to control the use of some of these herbal preparations. In other countries, medical practitioners should also be aware of the possibility that these herbal-medicine-related remedies may cause significant clinical problems in their Chinese patients.

Dharmananda, S. ITM START 1993 Nov, The Story of Jin Bu Huan; Institute for Traditional Medicine, Portland, OR

Dharmananda, S. ITM START 1996Nov ,Drugs in Imported Chinese Herb Products; Institute for Traditional Medicine, Portland, OR

Ferguson JE, Chalmers RJ, Rowlands DJ.  Reversible dilated cardiomyopathy following treatment of atopic eczema with Chinese herbal medicine.
Br J Dermatol 1997 Apr;136(4):592-593
Abstract:  Chinese herbal medicines are increasingly being used as an alternative treatment for chronic skin disease. Most patients and many doctors remain insufficiently aware of their potential toxicity. We report a patient with eczema who developed a severe cardiomyopathy following a 2-week course of Chinese herbal medicine. The connection between the two conditions was not made until 2 weeks after presentation when the patient was specifically asked if she had ingested any unusual substances. The belief that herbs, as natural products available without prescription, are harmless, is commonplace and patients may not consider them worthy of mention during a standard medical history.

Fratkin, Jake Paul, OMD. Oriental Medicine Journal. Vol. 6, No. 3-4, Fall/Winter 1997
Horowitz RS, Feldhaus K, Dart RC, Stermitz FR, Beck JJ.  The clinical spectrum of Jin Bu Huan toxicity. Arch Intern Med 1996 Apr 22;156(8):899-903
Abstract:  Herbal medications and other nontraditional medical therapies are becoming increasingly popular in the United States. We describe three children and three adults in whom severe toxic effects developed after ingestion of a Chinese herbal medication, jin bu huan, which is sold as Jin Bu Huan Anodyne Tablets. Jin bu huan produced distinct clinical syndromes after acute ingestion in children and long-term use in adults. A single, acute ingestion in children rapidly produced life-threatening neurologic and cardiovascular manifestations, while long-term jin bu huan use in adults was associated with hepatitis. Jin bu huan contains levo-tetrahydropalmatine, a potent neuroactive substance. The constituents of jin bu huan are misidentified on the package, resulting in significant delay in identifying the plant alkaloid responsible for its toxicity. Although perceived as innocuous, jin bu huan may produce major health effects. The highly concentrated formulation, the lack of childproof packaging, and the product insert listing indications for the treatment of serious medical conditions may all contribute to the development of toxic reactions.


Huang WF, Wen KC, Hsiao ML.
Adulteration by synthetic therapeutic substances of traditional Chinese medicines in Taiwan.
J Clin Pharmacol 1997 Apr;37(4):344-350
 Abstract: The adulteration by synthetic therapeutic substances of traditional Chinese medicines has been reported on various occasions and has been a public health concern in Taiwan over the past several years. A large-scale effort was initiated in 1992 to screen traditional Chinese medicines that were suspected of adulteration with synthetic therapeutic substances. The term "adulteration" refers to traditional Chinese medicines that are tested and found to contain chemical substances not prescribed or labeled as part of the intended use. A total of 2,609 samples were collected by eight major general hospitals in Taiwan. Samples were collected through physicians' referrals during patients visits. The samples were analyzed by hospital pharmacists following the established standard procedures in comparison to references by thin-layer chromatography. An average of 23.7% (n = 618) of the samples collected from the eight hospitals were adulterated. Four samples with either a rheumatoid or an antiinflammatory indication contained six different kinds of adulterants. More than half (52.8%) of the adulterated traditional Chinese medicines contained two or more adulterants. The sources of adulterated samples and their claimed indications, as well as the most frequently detected synthetic therapeutic substances, are presented in this report. The controversies regarding the combination of synthetic therapeutic substances and traditional Chinese medicines without adequate labeling should be resolved through regulatory actions for better safety of drug use.

Kang-Yum E, Oransky SH.  Chinese patent medicine as a potential source of mercury poisoning. Vet Hum Toxicol 1992 Jun;34(3):235-238
Abstract:  This research is an effort to create an awareness. of the potential hazards of some Chinese patent medicines which contain mercurial ingredients. This should be of consideration when screening symptomatic patients who are of Asian ethnic background or other users of these medicines. This research discusses reported cases of mercury poisoning related to the use of Chinese patent medicines and the potential toxicity of cinnabar (red mercuric sulfide) and calomel (mercurous chloride), 2 mercurials commonly used in these medicines. A list of mercurial-containing Chinese patent medicines available on the open market in North America has been compiled, together with their traditional uses and mercurial contents and is presented as a quick reference for Specialists in Poison Information. This class of medicine may not pose a problem when used appropriately; however, its misuse, abuse, overdosage and improper storage can lead to serious mercury poisoning.

Jin bu huan toxicity in adults--Los Angeles, 1993.MMWR Morb Mortal Wkly Rep 1993 Dec 3;42(47):920-922
Abstract:  Jin Bu Huan (JBH) is a traditional Chinese herbal product used as a sedative and analgesic. During 1993, public health and health-care providers in Colorado reported three children with unintentional overdoses of JBH that caused central nervous system and respiratory depression with rapid onset of life-threatening bradycardia. Subsequently, the first cases of acute hepatitis attributed to use of JBH were diagnosed in three women in Los Angeles during July and August 1993. Patients 1 and 2 were referred to a Los Angeles hepatology clinic by their physicians; patient 3 was identified by patient 2. All three patients had purchased JBH at the same health-food store. This report summarizes the investigation of these cases.

Jin bu huan toxicity in children--Colorado, 1993.MMWR Morb Mortal Wkly Rep 1993 Aug 27;42(33):633-636
Abstract:  The consumption of traditional ethnic remedies can have adverse health effects, especially among children. Life-threatening bradycardia with rapid onset and central nervous system (CNS) and respiratory depression developed in three unrelated children in Colorado during 1993 following ingestion of Jin Bu Huan tablets, a Chinese herbal medicine used for relieving pain. This report summarizes the investigations of these cases.

Picciotto A, Campo N, Brizzolara R, Giusto R, Guido G, Sinelli N, Lapertosa G, Celle G.
Chronic hepatitis induced by Jin Bu Huan. J Hepatol 1998 Jan;28(1):165-167
Abstract:  BACKGROUND/AIMS: Jin Bu Huan and other Chinese herbal products are widely taken remedies. They have been developed as a natural alternative to traditional drugs in the treatment of various ailments. Their ability to induce several side effects such as acute hepatitis has already been described. We report a case of chronic hepatic damage following administration of Jin Bu Huan Anodyne tablets. METHODS: The patient, a 49-year-old man, developed biochemical signs of liver damage 2 months after beginning Jin Bu Huan intake (3 tablets/daily) including biopsy-proven chronic hepatitis with moderate fibrosis. Virological, autoimmune, metabolic or other hepatotoxic causes were excluded. Liver function impairment was resolved by discontinuing Jin Bu Huan intake. CONCLUSIONS: This case reinforces the already known hepatotoxicity of this product and should make us think more about the uncontrolled use of alternative products.

Ries CA, Sahud MA.
Agranulocytosis caused by Chinese herbal medicines. Dangers of medications containing aminopyrine and phenylbutazone. JAMA 1975 Jan 27;231(4):352-355
Abstract:  Four non-Chinese patients, middle-aged or older, developed agranuloctyosis while taking Chinese herbal medicines for relief of arthritis and back pain. All four developed life-threatening infections with bacterial sepsis; one died. The herbal medicines were shown to contain substantial amounts of undeclared aminopyrine and phenylbutazone, drugs that are well-known causes of agranulocytosis. These Chinese herbal medicines are widely available over the counter throughout the United States.

Tie B, Qi W, Chen G.  Determination of soluble mercury contents in Chinese traditional patent medicines for children. Chung Kuo Chung Yao Tsa Chih 1990 Oct;15(10):602-604, 639
Abstract:  Soluble mercury contents in Baochi San, Xiaoer Zhibon Ding and Xiaoer Baishou Dan have been determined using dithizone method. This method has the advantages of short digestion time, clear digestion end point, simple operation and reproducible results. The recovery rate ranges from 98.4 to 103%. The data obtained can be used as a reference for controlling soluble mercury contents in Chinese traditional patent medicines containing cinnabar.
Woolf GM, Petrovic LM, Rojter SE, Wainwright S, Villamil FG, Katkov WN, Michieletti P, Wanless IR, Stermitz FR, Beck JJ, et al.  Acute hepatitis associated with the Chinese herbal product jin bu huan. Ann Intern Med 1994 Nov 15;121(10):729-735
Abstract:  OBJECTIVE: To describe the hepatotoxicity associated with ingestion of the Chinese herbal product Jin Bu Huan Anodyne Tablets (Lycopodium, serratum) and to propose possible mechanisms of injury. DESIGN: Retrospective analysis. SETTING: Academic hepatology units and private practice facilities. PATIENTS: Seven previously healthy patients. MEASUREMENTS: Clinical, laboratory, radiologic, and histologic studies. RESULTS: Acute hepatitis occurred after a mean of 20 weeks (range, 7 to 52 weeks) of Jin Bu Huan ingestion and resolved in six patients within a mean of 8 weeks (range, 2 to 30 weeks); another patient is currently improving. Hepatitis was associated with symptoms of fever, fatigue, nausea, pruritus, and abdominal pain and with signs of jaundice and hepatomegaly. Biopsy specimens showed that one patient had hepatitis with eosinophils (consistent with a drug reaction) and the other had mild hepatitis, moderate fibrosis, and microvesicular steatosis. Decreasing the Jin Bu Huan dose in one patient improved liver test results. Reusing Jin Bu Huan in two other patients caused abrupt recrudescence of hepatitis. CONCLUSION: Jin Bu Huan can cause liver injury. Although the hepatotoxic mechanisms are not defined, they may include hypersensitive or idiosyncratic reactions or direct toxicity to active metabolites. Hepatotoxicity caused by herbal products underscores the toxicity caused by herbal products underscores the importance of national surveillance programs and quality control of the manufacture of these products.


  • Comment in: Ann Intern Med 1994 Nov 15;121(10):803-804
  • Comment in: Ann Intern Med 1995 Apr 15;122(8):636

Zhang ZW, Watanabe T, Shimbo S, Higashikawa K, Ikeda M.  Lead and cadmium contents in cereals and pulses in north-eastern China Sci Total Environ 1998 Sep 18;220(2-3):137-145
Abstract:  It is known that, unlike Japanese, Koreans or southern Chinese who depend on rice as a major source of energy for daily life, people in north-eastern China rely not only on rice, but on wheat and other cereals and to a lesser extent also on pulses. Cereal and pulse samples were collected from open markets in north-eastern China, and analyzed by inductively-coupled plasma spectrometry (ICP-MS) for two potentially hazardous heavy metals--lead (Pb) and cadmium (Cd). The average Pb level in cereals (31.3 ng Pb/g as a geometric mean) and that of pulses (25.7 ng Pb/g) were similar to each other with no significant difference. Among the cereals, Pb contents were higher in foxtail millet (54.3 ng/g) and lower in maize (35.4 ng Pb/g; grain and flour in combination), wheat flour (28.8 ng Pb/g) and rice flour (22.7 ng Pb/g). Lead levels in two important types of pulses, kidney bean and soybean (24.6 and 30.8 ng Pb/g, respectively), were comparable to the levels in rice and wheat. In contrast, Cd levels were substantially higher in pulses (55.7 ng Cd/g) than in cereals (9.2 ng Cd/g), and among the pulses, Cd in soybean (55.7 ng Cd/g) was significantly higher than that in kidney bean (23.8 ng Cd/g). The possible public health implication of the Pb and Cd levels, especially the high Pb level in foxtail millet (54.3 ng Pb/g) and the high Cd level in soybean (73.5 ng Cd/g), is discussed.


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