an overview of adverse drug reaction monitoring in china

An Overview of Adverse Drug ReactionMonitoring in ChinaYibing Zhou,1 Victor Miller,2 Matthew Hogan2 and Larry Callahan2

1 Center for Research Information (China), Guangzhou, Peoples Republic of China2 Center for Research Information, Inc., Silver Spring, Maryland, USA

Abstract China’s National Center for Adverse Drug Reaction (ADR) Monitoring was established in 1989. In 1998,nearly a decade later, China joined the World Health Organization’s (WHO) Programme for International DrugMonitoring. During March 2004, China formally promulgated the final version of the Regulations on AdverseDrug Reaction Reporting and Monitoring. This modern system supplements an informal reporting system inscholarly publications that dates back to ancient times.

Procedurally, the formal Chinese monitoring system requires pharmaceutical industry and healthcare pro-fessionals to report most ADR events quarterly. However, new, uncommon, serious or ‘group’ ADRs arerequired to be reported within a shorter time period. Reports will be made to local centres, which then analyseand transmit them to a national ADR centre operated by China’s State Food and Drug Administration (SFDA).The national authority is then empowered to authorise further studies, publish formal warning announcementsor prohibit use of a product.

Traditional Chinese medicine (TCM) products are also regulated as drugs in China. Because TCM productuse is greatly increasing worldwide, Chinese ADR monitoring is particularly, if not uniquely, useful in itsreporting of TCM-related ADRs. A survey of Chinese ADR alerts and findings regarding TCMs and othersubstances is included, providing an overview of the breadth and timeliness of the information available fromChina’s increasing pharmacovigilance. Overall, the system shows considerable progress and promise, especiallyif ADR reporting procedure awareness continues to grow among China’s healthcare professionals and public.

CURRENT OPINION Int J Pharm Med 2006; 20 (2): 79-851364-9027/06/0002-0079/$39.95/0

© 2006 Adis Data Information BV. All rights reserved.

Drug safety has long been a global concern, and postmarketadverse drug reaction (ADR) monitoring has become a critical issuethroughout the world. In 1968 the World Health Organization (WHO)launched the WHO Programme for International Drug Monitor-ing – a worldwide collaborative ADR monitoring project. Thatproject resulted in the creation of Vigibase, a database maintainedby the WHO Uppsala Monitoring Centre containing over 3 mil-lion ADR reports from 75 countries.[1] Although ADR monitoringprogrammes have been making steady progress, there is consen-sus that these programmes are suboptimal in both the developed anddeveloping world.[2] China (technically a developing country butone with a recorded civilisation exceeding 5000 years) has beenmaking sustained efforts to enhance ADR monitoring. With theworld’s largest population (1.3 billion) and a history of extensivestudy and use of traditional Chinese medicines (TCMs), Chinarepresents a uniquely important source of ADR information.

China’s pharmaceutical industry has maintained steadygrowth in recent years. In 2004, the total annual drug sales income(both TCMs and Western medicines) in China reached 347.61billion yuan [RMB] ($US43 billion) – a 17.4% increase over 2003.[3]

The overall increase in drug usage inevitably results in moreADR events. ADR incidence rates in hospitalised patients inChina have ranged from 10% to 30% during the period in whichADR records have been kept.[4] Consequently, greater attentionis being paid to ADR issues, not only by the Chinese governmentbut also by healthcare professionals and consumers.

This article presents a comprehensive overview of currentand historical ADR monitoring and pharmacovigilance practicesin China. Special emphasis is placed on ADRs from TCM in lightof the unique and historical association of the use of these productsthroughout China and in Chinese populations throughout theworld.

1. History and Statistics

ADRs have been recorded and studied in China for over 2000years. In Shen Nong Ben Cao Jing, one of the oldest knownChinese medical manuscripts (published in the Dong Han Dynastybetween 25 AD and 220 AD), TCM herbs were classified byefficacy and toxicity with various categories applied, such as“superior, medium or inferior” and “highly-toxic, toxic, low-toxicityor non-toxic”. In the Chinese materia medica, herbs are now clas-sified primarily according to their safety or potential toxicity.[5]

Herbs that are classified as ‘upper class’ (superior) are nontoxic,and used as tonic remedies. ‘Middle class’ (ministerial) herbsmay exhibit a mild degree of toxicity, supporting the superiormedicines. Finally, the ‘lower class’ (inferior) remedies are toxic,and to be used only for specific problems for limited periods oftime.[6]

Since ancient times, Chinese doctors have systematicallymonitored TCMs and their ADRs in order to improve the thera-peutic benefits and reduce or eliminate the toxic effects of TCMs.The earliest Chinese medical (TCM) journal, Wu Yi Hui Jiang,was published in 1792,[7] and medical journals specifically devotedto the adverse effects of TCMs date back to 1915.[8] These journalscan serve as primary sources of information about TCM ADRevents.

Formal, official ADR monitoring programmes started rela-tively late in China, compared with most Western countries.China’s first pilot ADR monitoring projects began in 1988 andinvolved 10 regional medical organisations within severalcities and provinces, including Beijing, Shanghai, Hubei,Heilongjiang, along with several other provinces. In November1989, the National Center for ADR Monitoring was establishedand 85 hospitals became responsible for monitoring ADR events.China then joined the WHO Programme for International DrugMonitoring in 1998, contributing thousands of reports on bothTCMs and conventional medications. The next year, the ChineseState Food and Drug Administration (SFDA) and the Ministry ofHealth issued draft regulations governing ADR monitoring. Thedraft regulations were officially finalised and promulgated inMarch 2004 as the Regulations on Adverse Drug Reaction Re-

porting and Monitoring.[9] The regulations contain 6 chapters and33 line-items, comprising the administrative responsibilities,reporting procedures and measures for evaluation and control.They also list the penalties for contravening any of these regula-tions. The issuance of regulations signalled a new era of ADRmonitoring in China and led to the establishment of provincialmonitoring centres for systematic ADR reporting.

The new regulations and the establishment of monitoringcentres have resulted in a dramatic increase in the number ofADRs reported during the last several years (see figure 1). TheSFDA reported that it received a total of 4027 ADR reports between1989 and 1999. After 1999, the year of the draft regulations, ADRreporting soared. A total of 4708 reports were submitted in 2000,increasing to 36 852 in 2003,[10] and 70 050 in 2004.[11] ADRreports reached a new high in 2005, with a total of 173 000 re-ceived by the National ADR Monitoring Center that year.[11]

ADR reports for each of these years embraced both allopathic(Western) drugs and TCMs.

Despite the dramatic increases in China’s ADR reportingover the past few years, both the source and the number of ADRreports remain limited. Hospital healthcare professionals remainresponsible for approximately 99% of all ADR reports. Pharmaceu-tical manufacturers and consumers generate an extremely smallnumber of reports. The total number of reports is also low comparedwith those of developed countries. For example, with a popula-tion only one-fifth that of China, the US generated over 300 000ADR reports in 2003. Preliminary figures issued by the US Foodand Drug Administration (FDA) indicate that more than 420 000ADR reports were received in 2004 (data for 2005 are not yetavailable). The majority of US ADR reports come from pharma-ceutical manufacturers, as they are required to submit these to theFDA.[12] In China, studies have shown that awareness of theproper procedures for ADR reporting still eludes most healthcareprofessionals and under-reporting remains a challenge.[13]

2. Regulatory Structure

In China, the SFDA is the nationwide authority for the super-vision of both food and drug safety. The SFDA body that specif-ically oversees and manages ADR reporting and monitoring ona day-to-day basis is the Center for Drug Reevaluation (the insti-tute is more commonly known as the National Center for ADRMonitoring or, more simply, the National Monitoring Center).

36 852

0

50 000

100 000

150 000

200 000

4027

1989–1999

4708

2000

7718

2001

17 000

2002 2003

70 050

2004

173 000

2005

Year

Num

ber

of r

epor

ts

Fig. 1. Total number (for both Western and traditional Chinese medicines)of adverse drug reactions reported between 1989 and 2005.

80 Zhou et al.

© 2006 Adis Data Information BV. All rights reserved. Int J Pharm Med 2006; 20 (2)

Under the National Monitoring Center’s supervision, 32 provincial,autonomous regional and municipal ADR monitoring centreshave been established.[14]

The finalised Regulations on Adverse Drug Reaction Report-ing and Monitoring, issued in 2004 by the Ministry of Health andSFDA, require all ADRs to be monitored and reported by drugmanufacturers, distributors and medical organisations. These en-tities are directed to designate full- or part-time staff membersdirectly responsible for ADR reporting and monitoring. The as-signed staff must record, investigate, analyse and transmit anypossible ADR to the appropriate monitoring centre on an ADREvent Reporting Form. The timeframe in which the Event ReportingForm should be submitted to a provincial ADR monitoring centrevaries according to the nature of the ADR.

The system also allows for individuals to make ADR reports.New or serious ADRs discovered by individuals may be reportedto the provincial ADR monitoring centres. They may also bereported directly to the SFDA.

Generally, entities subject to the ADR regulations are requiredto report all ADRs quarterly. However, if an ADR is new orserious the reporting period reduces to 15 days. ADRs involvingdrugs that cause fatalities, that are used to prevent or treat epidemicsor are used in mass screening and treatment programmes, as well

as any ADR involving a biological preparation, must be reportedimmediately. The provincial ADR monitoring centres then reportall nonserious and previously known ADRs to the National Mon-itoring Center quarterly. For new or serious ADRs, the provincialmonitoring centre must affirmatively investigate and verify theevent, as well as report it to the National Monitoring Center within3 days. Those reports should be accompanied by suggestions forfollow-up action.

The National Monitoring Center compiles statistical data onall ADR events and reports them to the SFDA and the Ministryof Health every 6 months. When new, uncommon or serious ADRreports are received, or if group ADRs are received, these mustbe investigated, analysed, and evaluated and reported as quicklyas possible to the SFDA and Ministry of Health. The NationalADR Experts Advisory Committee, organised by the NationalCenter for ADR Monitoring, performs an analysis and evaluationon the new, uncommon, or serious ADR reports. These ADRexperts are usually selected from the provincial ADR ExpertsAdvisory Committees across the country. The National ADRExperts Advisory Committee also makes decisions on which newdrugs need intensive monitoring.

Figure 2 is a detailed ADR reporting flowchart approved bythe SFDA’s Center for Drug Reevaluation, which describes how

ADRdatabase

Drug manufacturing or distributing enterprisesMedical and healthcare organisationsIndividuals

Serious, uncommon or new ADR cases must bereported within 15 working days. ADR cases

involving epidemic prevention drugs, mass screeningand mass treatment drugs, or biological preparationsfor disease prevention must be reported immediately.

Other cases must be reported quarterly

Serious, uncommon or new ADRs occurring inprovinces without provincial ADR centres must be

reported within 15 working days. ADR cases involvingepidemic prevention drugs, mass screening and

treatment drugs or biological preparations fordisease prevention must be reported immediately.

Other cases must be reported quarterlySerious, uncommon or new ADR cases must be

investigated and reported within 72 hours,accompanied by suggestions for follow-up action.

Other cases must be reported quarterly

All ADR cases are analysed and organisedSerious, uncommon or new ADR cases areinvestigated, verified and reported after analysis

and evaluation by the National ADR Experts AdvisoryCommittee. Other cases must be reported quarterly

for statistical purposes

Provincial CenterFor ADR Monitoring

National CenterFor ADR Monitoring

SFDAMinistry of Health

Fig. 2. This flowchart outlines the adverse drug reaction (ADR) monitoring and reporting system as approved by the Center for Drug Reevaluation of theChinese State Food and Drug Administration (SFDA).

An Overview of Adverse Drug Reaction Monitoring in China 81


the official ADR monitoring and reporting system now operatesin China.

2.1 Adverse Drug Reaction (ADR) Information Bulletin

The SFDA publishes intermittent ADR warnings in its ChineseAdverse Drug Reaction Information Bulletin.[15] These warningsare designed to alert drug manufacturers, distributors and medicalorganisations to safety issues related to specific drugs. Their dataare derived from reports in the nationwide ADR reporting system.From November 2001 to April 2005, the SFDA published eightissues of the series, covering over 30 substances including TCMs.The contents are summarised and detailed in table I, and give anidea of the extent and nature of the work of the ADR monitor-ing system.

3. ADRs Pertaining to Traditional Chinese Medicines

TCM is one area where China can make a unique contribu-tion to pharmacovigilance worldwide. TCMs are highly valuedamong the Chinese and their use is growing throughout the restof the world as well. In China, TCMs are regulated in the sameway as drugs, so the monitoring of TCM-related ADRs has de-veloped simultaneously with the more general national concernsover pharmacovigilance. China’s widespread use of TCMs suggeststhe nation’s ADR monitoring and reporting systems, both formaland informal, constitute a unique and expanding resource forTCM information.

As shown in table I, China’s ADR monitoring system hasprovided detailed information and warnings on TCM products.Noticeably, however, it is TCMs administered parenterally whichpredominate in those ADR reports, while TCMs as a whole actu-ally produce only a small portion of the set of national ADRsreported. A 2003 address by an expert from the Center for DrugReevaluation stated that over the previous 10 years TCM-relatedADR reports accounted for only 5% of all ADR reports receivedby the National ADR Monitoring Center.[16] Data in the nationalADR database further reveals, nevertheless, that 77.5% of ADRsassociated with TCMs are specifically from TCM injections(TCMI).[17] A report by Liu in 2004 indicated that, over the period1989–1999, nearly half (46.5%) of all TCM-related ADRs wereTCMIs. That same period included reports of 131 cases of ana-phylactic shock due to TCMIs.[18]

In addition to the formal ADR monitoring system, publishedChinese medical literature has also tracked the risks associatedwith TCMIs. Over the past few decades, medical literature reportsof allergic reactions induced by TCMIs have been increasing.

Between 1975 and 2001, 2600 cases of ADRs associated with 51different TCMI agents were documented in the literature inChina. The majority (69.9%) of these adverse reactions were ef-fects generally associated with allergic responses. These includedanaphylactic shock (10.2%), rashes (25.3%) and a variety of otherlife-threatening physiological responses (34.3%). Other ADRsincluded liver injuries (0.7%), dysfunctions of the digestive tract(9.2%), nervous system (5.6%), haematopoietic system (4.4%),cardiovascular organs (4.1%), urinary system (2.6%) and respi-ratory system (0.3%). Twenty-five cases of death attributable toTCMI-induced anaphylactic shock were described in Chinese-language medical literature to 2003.[19]

In May 2005, Lian-bi-Zhi injections (andorgrapholide withsodium hydrogen sulphite) were stopped and partially withdrawnfrom the market voluntarily by their manufacturers, shortly afterthe SFDA issued a warning on an associated renal ADR.[17] Thatwas the first time in China’s history that a TCMI was withdrawnfrom the market after official action.

Beyond the specific reactions associated with injections,TCM-related ADRs are, in general, also monitored and studied.Between 1915 and 1994, 6061 ADR cases associated with TCMswere reported in Chinese medical journals. The usefulness ofthese Chinese language reports may be indicated by the growinglevel of TCM usage and ADRs worldwide. According to theWHO Collaborating Centre for International Drug Monitoring(also known as the Uppsala Monitoring Centre), 4960 TCM-related ADR cases were reported worldwide in 1994, increasingto 8986 in 1999.[8]

It has, nonetheless, been noted that adverse effects fromTCMs are relatively rare in comparison to conventional pharma-ceuticals. In a study conducted in the early 1990s, researchersnoted that only 0.2% of the general medical admissions to thePrince of Wales Hospital in Hong Kong were due to ADRs toTCMs. This compared quite favourably to the 4.4% of admissionscaused by allopathic pharmaceuticals;[20] still, clearly, TCMs arenot without risks. A variety of clinical studies provides evidencethat nonparentally administered Chinese herbal preparations canexhibit a wide range of toxic properties.

Examples of TCMs reported to contain compounds whichhave elicited ADRs include the following:• Aconites (Radix Aconiti, Radix Aconiti Lateralis Preparata,

Radix Aconiti Kusnezoffii, etc.) and toad venom (Venenum

Bufonis) are substances that adversely affect the cardiovas-cular system, potentially causing arrhythmia and strokes.

• Air potato yam rhizome (Rhizoma Dioscoreae Bulbiferae),Siberian cocklebur fruit (Fructus Xanthii) and chinaberry

82 Zhou et al.


Table I. Chinese adverse drug reaction (ADR) information bulletins issued by China’s State Food and Drug Administration (SFDA)[15]

Issue no.

Date ofpublication

Drug name Adverse reactions

8 04/2005 Lian-bi-Zhi injectiona (andorgrapholide with sodiumhydrogen sulphite)

Acute renal function impairment

Hydroxythyl starch 20,40 sodium chloride injections Renal function impairment

Ke Ying Yuana (Rhizoma Smilacis Glabrae + CortexDictamni + Rhizoma Menispermi, etc.)

Liver lesion, exfoliative dermatitis

7 11/2004 Turmeric oil injectiona Allergic reactions, skin rash, dyspnoea

Trasylol injection Allergic reactions

6 04/2004 Traditional Chinese medicines containing aristolochic acida Renal toxicity

L-imidazole, mebendazole and albendazole Encephalitis syndromes

Fenfluramine hydrochloride Serious cardiotoxic effects

5 12/2003 Amikacin injection Ototoxicity, renal toxicity

Lincomycin injection Ototoxicity, neuromuscular block reaction

Ciprofloxacin injection Skin lesion, phlebitis, digestive system symptoms, neurologicalabnormalities

Clindamycin injection Skin lesion, digestive system symptoms, allergic shock

4 08/2003 Metoclopramide tablet, injection Extrapyramidal system reactions

Yu-xing-cao (heartleaf houttuyinia herb) injectiona Allergic and transfusion reactions

Iodinated oil gel Headache, dizziness, nausea, vomiting, tremor, etc.

Carbamazepine tablets Serious skin lesion, haematological events

Antondine injections Skin lesion, haematological events, urinary toxicity, anaphylacticshock

3 12/2002 Dextran 40 Anaphylactic shock

Mannatide injection Itching, rash, chest distress, difficult breathing

Puerarin injection Rash, general allergic reaction (including anaphylactic shock),haemolytic anaemia

Chuan-hu-ning (potassium dehydroandrograpolidesuccinate) injections

Rash, dyspnoea, fever, anaphylactic shock, blood plateletreduction, etc.

Shen-mai injectiona (Ginseng and dwarf lilyturf root) Allergic and transfusion-associated reaction

2 07/2002 Gan-mao-tong tablets (diclofenac + artificial calculus bovis+ chlorphenamine)

Upper digestive tract bleeding, haematuria, allergic reactions

Long-dan Xie-gan Wana (containing aristolochic acid) Renal toxicity

Astemizole tablets Allergic reactions, cardiovascular events

Ketoconazole tablets Liver toxicity

Metamizole sodium tablets and injections Anaphylactic shock, haematological events, skin and affiliatedorgan reactions, urinary system reactions, digestive systemreactions

Methylrosaniline chloride solution Dermatitis

Cerebroprotein hydrolysate injection Chill, fever, rash, anaphylactic shock

Ticlopidine tablets Aplastic anaemia

Clozapine tablets Granulocytopenia

1 11/2001 Bimolane tablets, capsules Leukaemia

Zhang Gu Guan Jie Wana (Rhizoma Cibotii, Koreanepimedium herb, Radix Angelicae Pubescentis, etc.)

Liver lesion, hypertension, allergic reactions

Qing-kai-ling injectionsa Allergic reactions

Shuang-huang-lian injectionsa (Honeysuckle flower, baikalskullcap root, weeping forsythia)

Allergic and transfusion-associated reactions

Benzyl alcohol as injection menstruum Atrophy of gluteal muscle

a Traditional Chinese medicines.



bark (Cortex Meliae) can cause liver toxicity, manifesting ashepatitis.

• The Manchurian dutchmans pipe stem (Caulis AristolochiaeManchuriensis), also known as Manchurian birthwort, isknown to contain aristolochic acid, which adversely affectsrenal function and has been banned by the SFDA.

• Medicinal herbs such as Manchurian wild ginger herb(Herba Asari) and Siberian cocklebur fruit (Fructus Xanthii)can cause kidney toxicity.

• Toxic responses of the respiratory system have been inducedby overdoses of any one of the following TCMs: sessilestemona root (Radix Stemonae), motherwort herb (HerbaLeonuri), almonds (Semen Armeniacae Amarum) and peachseeds (Semen Persicae).

• Chronic exposure to Realgar (an arsenic-containing substance)and Black Tin Pill can exert a direct toxic effect on the cir-culatory system, the blood vessels and other large organs.Haematopoiesis may be impaired and bleeding may occur.

• Overdoses of Nux Vomica (Semen Strychni) and HinduDatura seed (Semen Daturae) can adversely affect the cen-tral nervous system causing tremors and convulsions.[21]

The issue of aristolochic acid toxicity illustrates the useful-ness of ADR findings in China. In 1993, a well known aristolo-chic acid incident occurred, arousing worldwide concerns aboutTCM-related ADRs. Belgian scientists reported nine cases ofrenal failure resulting from diet pills containing aristolochicacid.[22] However, because of the language barrier, very few peo-ple in the West knew that some of the earliest cases reported ofrenal failure attributable to aristolochic acid-containing herbswere published in Chinese medical journal articles in 1964 and1965.[23,24] These reported three cases of renal failures (includingtwo fatal cases) induced by Guan Mutong (Caulis AristolochiaeManshuriensis), a herb containing aristolochic acid.[23,24]

More recent studies in Taiwan have indicated that there is astrong relationship between progressive interstitial renal fibrosisand the consumption of Chinese herbs. These studies indicatethat, in addition to aristolochic acid, other unidentified phytotox-ins play a role in inducing nephrotoxicity.[25]

4. Conclusion

Within the last 2 decades China officially put in place a sys-tematic ADR monitoring and reporting system encompassingWestern medicine pharmaceuticals and TCMs. This system hasgreatly increased the number and systematisation of ADR reports.However, there remains much to be done to perfect the reportingsystem. It is important that the pharmaceutical industry contrib-

utes more significantly to ADR reporting, and that more incen-tives are provided for professionals and individuals to increasethe quality and quantity of their reports.

China might also develop its international activities in thisarea, benefiting from enhanced collaboration with the WHO, aswell as undertaking bilateral efforts with other countries. Maintain-ing the flow and exchange of ADR information internationally,and across linguistic barriers, with careful note taken of both theformal reporting system and the body of reports in Chinese sci-ence literature (and special advantage being taken of ADR infor-mation in China associated with TCMs) should enhance China’ssystem while enriching pharmacovigilance worldwide. Chinashould also develop internally and benefit substantially as greaterawareness of ADR reporting procedures is promoted among itsindustry and healthcare professionals.

Acknowledgements

No sources of funding were used to assist in the preparation of thisreview. The authors have no conflicts of interest that are directly relevant tothe content of this review.

References1. Uppsala Monitoring Centre. Vigibase − the database story: 3 million ADR reports.

Uppsala Reports; 2004 January [online]. Available from URL: http://www.umc-products.com/graphics/2030.pdf [Accessed 2006 Jan 24]

2. Centers for Education and Research on Therapeutics Risk Assessment Workshop.Risk assessment of drugs, biologics and therapeutic devices: present and futureissues. Pharmacoepidemiol Drug Saf 2003; 12 (8): 653-62

3. Report on the biotechnology and new pharmaceutical industry in Beijing [in Chi-nese]. Beijing: Beijing Pharma and Biotech Center, 2005

4. Sun DR, Qi P, Jian YH. Adverse drug reactions [in Chinese]. Beijing: People’sMedical Publishing House, 2003

5. Xu L, Wang W. Chinese materia medica: combinations and applications. St Al-bans: Donica Publishing, 2002

6. Kuhn MA, Winston D, Der Marderosian AH. Herbal therapy and supplements: ascientific and traditional approach. Philadelphia (PA): Lippincott, 2000

7. Yang J. The earliest medical journal in China [in Chinese]. Da Zong Jian Kang2004; 4: 42

8. Feng KY. A review of adverse reactions caused by traditional Chinese medicines[in Chinese]. Chinese J Ind Med 2003; 16 (5): 315-9

9. Regulations on adverse drug reaction reporting and monitoring [in Chinese].China Ministry of Health & State Food and Drug Administration [online].Available from URL: http://www.cdr.gov.cn/doc/content.jsp?id=10301&channel%=% D5%FE%B2%DF%B7%A8%B9%E6 [Accessed 2006 Apr 19]

10. Document compilation for the 2nd National ADR Monitoring Meeting [in Chinese].Department of Drug Safety & Inspection, SFDA. Apr 2004 [online]. Availablefrom URL: http://www.cdr.gov.cn/docbase/infodata/2005-05-24/11090/ns45ny8OuaOoMywp.doc [Accessed 2006 Apr 19]

11. Hou YL. ADR reports in China reached a new peak in 2005 [in Chinese]. ChinaPharm News 2006 Jan 5: section A1

12. US Food and Drug Administration, Rockville (MD). Data on file13. Li Q, Zhang SM, Chen HT, et al. Awareness and attitudes of healthcare profes-

sionals in Wuhan, China to the reporting of adverse drug reactions. Chin MedJ (Engl) 2004 Jun; 117 (6): 856-61

14. Zhou XQ, Zhou J. Achievements, misunderstandings and problems in ADR mon-itoring in China [in Chinese]. China Pharmacy 2004; 15 (3): 134-5

84 Zhou et al.


15. Chinese adverse drug reaction information bulletin [in Chinese]. National Centerfor Drug Reevaluation, State Food and Drug Administration [online]. Availablefrom URL: http://www.cdr.gov.cn [Accessed 2006 Apr 5]

16. Zhu Q. TCM safety issue emerged onto the surface [in Chinese]. China PharmNews 2003 Apr 1; (47): 3

17. Zhang DF. Be cautious with traditional Chinese medicine injections [in Chinese].China Trad Chin Med News 2005 Nov 9: 4

18. Liu E. Research progresses and countermeasures on adverse reactions of TCM.Chin New Med J 2004; 1 (1): 46-9

19. Liang JQ, Zou YP, Deng XC. Literature investigation and analysis of ADRs oftraditional chinese medicine injections [in Chinese]. Chin Hosp Pharm J 2003;23 (8): 486-8

20. Chan TYK, Chan AYW, Critchley JAJH. Hospital admissions due to adversereactions to Chinese herbal medicines. J Trop Med Hyg 1992; 95: 296-8

21. Zhong DJ. Study and prevention of adverse reactions of traditional Chinese medicine[in Chinese]. Zhejiang J Trad Chin Med 2003; 13 (12): 727-9

22. Vanherweghem JL, DePierreux M, Tielemans C, et al. Rapidly progressive inter-stitial renal fibrosis in young women: association with slimming regimen in-cluding Chinese herbs. Lancet 1993; 341 (8842): 387-91

23. Wu SH. Report of two cases of acute renal failure induced by Mutong [in Chinese].Jiangsu J Trad Chin Med 1964; 10: 12-3

24. Hong YS, Huang YL, Wang YJ. One fatal renal failure case caused by high doseof Mutong [in Chinese]. Zhejiang J Trad Chin Med 1965; 8 (12): 32

25. Chang CH, Wang YM, Yang AH, et al. Rapidly progressive interstitial renal fibro-sis associated with Chinese herbal medications. Am J Nephrol 2001; 21 (6):441-8

Correspondence and offprints: Mr Victor Miller, Center for Research Infor-mation, Inc., Silver Spring, MD 20910, USA.E-mail: [email protected]



an overview of adverse drug reaction monitoring in china

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