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JKM > Volume 36(1); 2015 > Article
Kim and Han: Herbal-drug-associated Adverse Events Reported in the Internet Newspaper Articles

Abstract

Objectives:

The aim of this study was to understand the characteristics of herbal-drug-associated adverse events (AEs) reported in the internet newspaper articles and to take a countermeasure against the safety issue of herbal drugs.

Methods:

We searched the internet newspaper articles published from 2010 to 2014 in the 3 major portal sites in Korea, NAVER, DAUM, and GOOGLE. Search terms were the Korean words equivalent of ‘herbal drug’ and ‘side effects’. Informations on the type and characteristics of suspected herbal drugs, AEs, and the patient records were extracted from the articles reporting the herbal-drug-associated AE occurred in Korea.

Results:

From 8,806 articles, a total of 36 AEs were found. The most frequently reported age group was 20s, and women outnumbered men. Obesity was the most common cause of administration. Doctors of Korean medicine clinic were the most commonly referred prescribers and purchasing route (11 cases). The most frequently mentioned medicinal herb was Ephedra sinica (7 cases) and the most commonly reported AEs were abdominal pain (8 cases), dizziness (6 cases), diarrhea (5 cases), and vomiting (5 cases) were followed in order. Ten cases were judged as serious AEs, and the others were not.

Conclusions:

Current customers demand health care providers to offer them sufficient information on the safety of herbal drugs. To satisfy their requirements, physicians of Korean medicine should be able to explain, predict, prepare, recognize, and deal with the herbal-drug-associated AEs. We propose an establishment of pharmacovigilance system for herbal medicine, in which doctors of Korean medicine are participated as important personnel, to collect and analyze the related AEs and offer credible information on the safety of herbal drug.

Table 1.
Number of the Searched Internet Newspaper Articles and Herbal-drug-associated Adverse Events.
Year NAVER DAUM GOOGLE TOTAL Adverse Events
2010 645 436 75 1156 10
2011 832 871 103 1806 7
2012 644 869 106 1619 5
2013 733 646 212 1591 9
2014 1276 910 448 2634 5
2010–2014 4130 3732 944 8806 36
Table 2.
Characteristics of the Patients Experienced Adverse Events and the Kinds of Acquiring Herbal Drug.
Case No. Year Age group Gender No. of Pt. Indication Purchasing route Prescriber
1* 2010 20+ F 1 Obesity KMC KMD
2 2010 NR F 1 Obesity TEL NR
3 2010 60+ F 1 Obesity INT NR
4 2010 30+ M 1 NR KMC KMD
5 2010 NR NR NR Obesity INT Etc.
6 2010 NR NR 1 Arthritis Market Etc.
7* 2010 20+ F 1 Obesity NR NR
8 2010 40+ M 1 Dizziness KMC KMD
9 2010 10+ F 1 Anxiety NR NR
10 2010 NR NR 2 Inflammation, Pain, Atopic dermatitis TEL, DTD Etc.
11 2011 NR NR 1 Obesity TEL Etc.
12* 2011 NR NR 1 Obesity TEL Etc.
13 2011 NR M NR Impotence market Etc.
14* 2011 40+ M 1 Hypertension, Diabetes mellitus KMC KMD
15* 2011 NR NR NR Obesity TEL Etc.
16 2011 NR NR 1 Obesity TEL Etc.
17 2011 NR NR 1 NR KMC KMD
18 2012 10+ M 1 Failure to thrive KMC KMD
19 2012 NR NR NR Anxiety Pharmacy Pharm
20* 2012 10+ F 1 Contact dermatitis, Rheumatic arthritis KMC KMD
21 2012 30+ F 1 Obesity NR NR
22* 2012 20+ F 1 Obesity KMC KMD
23 2013 NR NR NR NR Market Etc.
24 2013 60+ NR 1 Headache, Apathy Market Etc.
25* 2013 70+ NR 1 Neuralgia Market Etc.
26 2013 NR NR NR NR Market Etc.
27 2013 40+ NR NR Prevention for cancer and Hyperlipidemia Multilevel Etc.
28 2013 50+ F 1 Hypertension, Climacterium Market Etc.
29 2013 NR NR NR Obesity TEL Etc.
30 2013 50+ M 1 Hemorrhoids Pharmacy Pharm
31* 2013 NR M NR Impotence INT Etc.
32 2014 20+ NR 1 Atopic dermatitis KMC KMD
33 2014 NR NR 1 Atopic dermatitis KMC KMD
34 2014 20+ F 1 Obesity INT NR
35 2014 20+ NR 1 Obesity INT Etc.
36* 2014 NR NR 7 Pain KMC KMD

*, serious adverse event. Abbreviations. No, number; Pt., patients; F, female; KMC, Korean medicine clinic; KMD, Doctor of Korean medicine; NR, not reported; TEL, telemarketing; INT, internet; M, male; DTD, door-to-door selling; Pharm, pharmacist; Multilevel, multilevel marketing.

Table 3.
Details on Herbal Drug Administration and Characteristics of Adverse Events.
Case No. Year Name of Drug Drug Type Herbs in Drug Duration (days) Type of AEs Result of AEs (days) Stop Reaction
1* 2010 NR HD NR 30 Vomiting, Dyspepsia Adm (7) NR
2 2010 HDP NR NR 4 Abdominal pain, Fever, Hepatic enzymes increased NR NR
3 2010 HDP NR NR NR Abdominal pain NR NR
4 2010 NR HD Deer antlers NR Rash NR NR
5 2010 My wellbeing jikimi NR Ephedra sinica, Akebia Caulis NR Tremor, Palpitation, Apathy, Dizziness, Thirsty NR NR
6 2010 natural tea NR Psoraleae Semen NR Arthralgia Medical Tx NR
7* 2010 NR HD NR NR Hepatitis Adm NR
8 2010 NR HD NR NR Dizziness Medical Tx NR
9 2010 UC HD Comp of UC NR Concentration impaired NR NR
10 2010 Cheonbi Drug+ NR NR Insomnia NR NR
11 2011 NR Herb Ephedra sinica NR Dizziness, Nausea NR NR
12* 2011 NR Herb Ephedra sinica NR Vomiting, Dyspepsia, Nausea Adm NR
13 2011 Jeongryeok-huan Drug+ Schisandra Fructus, Lycii Fructus NR Abdominal pain, Diarrhea NR NR
14* 2011 modified YD, SSE HD Comp of YD & SSE 75 Hepatic failure Hepatic TP NR
15* 2011 NR HD Ephedra sinica NR Hepatitis Adm (40) NR
16 2011 NR HD Ephedra sinica 1 Dizziness, Nausea NR Imp (after 10days)
17 2011 NR HD NR NR Abdominal pain NR NR
18 2012 NR HD NR NR Vomiting NR NR
19 2012 Sangmyeong-tang Drug+ Comp of PYS & HHT NR Paralysis, Somnolence NR NR
20* 2012 NR HD NR 60 Hepatitis Death NR
21 2012 NR NR NR NR Paraesthesia, Insomnia NR NR
22* 2012 NR HD NR 60 Hepatitis Adm (14) NR
23 2013 NR HD NR NR Rash NR NR
24 2013 NR HD Deer antlers, Kalopanacis Cortex NR Diarrhea, Abdominal pain NR NR
25* 2013 Aconiti Ciliare Tuber Herb Aconiti Ciliare Tuber NR Abdominal pain Death NA
26 2013 NR NR Deer antlers NR Abdominal pain NR NR
27 2013 Saengsik-huan Food+ NR NR Abdominal pain, Diarrhea NR NR
28 2013 NR Food+ NR NR Vomiting, Diarrhea NR NR
29 2013 NR HD Ephedra sinica,Paeoniae Radix, Zingiberis Rhizoma Crudus NR Tremor, Insomnia, Palpitation NR NR
30 2013 NR Drug+ NR NR Diarrhea Injury (3) NR
31* 2013 NR Drug+ Deer antlers, Lycii Fructus, Cordyceps NR Headache, Fever, Chest pain, Priapism Adm NR
32 2014 PGT HD Comp of PGT 240 Dermatitis, Apathy NR NR
33 2014 PGT HD Comp of PGT 130 Dermatitis Medical Tx Imp (after 30 days)
34 2014 NR NR NR 7 Vomiting, Dizziness, Palpitation NR NR
35 2014 NR HD Ephedra sinica 45 Dizziness, Dyspepsia NR NR
36* 2014 Geotong-huan HD Aconiti Tuber, Aconiti Ciliare Tuber NR NR 1 Death, 6 Injury NR

*, serious adverse event. Abbreviations. AEs, adverse events; NR, not reported; HD, herbal drug; Adm, admission; HDP, herbal diet product; Tx, treatment; UC, Uhuangcheongsim-huan; Comp, composition; YD, modified Yeoldahanso-tang; SSE, Samso-eum; TP, transplantation; PYS, Pyeongwi-san; HHT, Huangryeonhaedok-tang; NA, not applicable; PGT, Pyeongang-tang; Imp, improved.

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