• Korean Journal of Oriental Medicine
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• v.13 no.3
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• pp.79-85
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• 2007

Objective : To investigate documented surveys about adverse events of acupuncture therapy. Methods: We searched Medline with the terms of 'acupuncture/adverse event(s)', 'acupuncture/side effect(s)' and 'CAM/adverse event(s)' using Pubmed and set the limits to human study. Results: There were 5 prospective studies, 3 reviews and 3 surveys in our searching. There were 3 reports about acupuncture related adverse events in UK ranging from 10.7% to 15% of which the rate of significant events were from 0.13% to 0.14%. In Germany, there were 11% of acupuncture related adverse events in one report and 7.5%(significant events were 45 in 190,924 patients) in another report. In Australia, one study reported that every adverse event associated with acupuncture occurred in 8-9 month per one practitioner. In Japan, 0.14% of acupuncture related adverse events in 48 practitioners were reported in one systemic review. A cumulative review about significant adverse events associated with acupuncture reported 715 adverse events of which most frequent accidents were pneumothorax and central nervous system injury. Conclusion : The risk of adverse event associated with acupuncture is far lower than that associated with other general medical interventions. However, some safety guidelines about the acupuncture performance are needed.

• Korean Journal of Acupuncture
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• v.29 no.3
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• pp.421-430
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• 2012

Objectives : We investigated the incidence rate and type of adverse events associated with RCTs(Randomized Controlled Trials) of acupuncture and moxibustion. Methods : This study included 949 patients who received acupuncture or moxibustion or usual care from 8 RCTs. We collected data including gender and age of patients, intervention, treatment frequency and type of adverse events in clinical trials from their case report forms. Results : Among the 949 patients, 83 patients(8.7%) suffered at least one adverse event throughout the clinical trials. Types of adverse event in acupuncture & moxibustion clinical trials are common cold, skin changes, pain, dizziness, bruise, gastrointestinal diseases, changes of blood chemistry, burn. Adverse events were significantly correlated to patients' age, intervention, body mass index and treatment group. Conclusions : A Guide-line for collecting and managing adverse events of acupuncture & moxibustion clinical trials are needed.

• The Journal of Pediatrics of Korean Medicine
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• v.28 no.3
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• pp.1-16
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• 2014

Objectives The purpose of this study is to investigate the incidence and clinical features of adverse events associated with herbal medicine, and to analyze their causality and severity. Methods This study was carried out from 159 children and adolescents who took herbal medicine in the Department of Pediatrics, ${\bigcirc}{\bigcirc}$ Korean Medical Hospital from december, 2013 to april, 2014. The data was collected by survey in person or telephone. The World Health Organization (WHO)-Uppsala Monitoring Center (UMC) criteria was used to analyze causality for each adverse events. Results 1. 207 cases were surveyed from 159 children and adolescents who took one or more kinds of herbal medicine. 2. A total of 12 general adverse events (5.8%) were reported from the study. Among these adverse events, 8 cases (3.9%) were associated with herbal medicine. 3. Gastro-intestinal system disorders were most frequently reported (70%) as adverse events, which is followed by psychiatric disorders (15%), skin and appendages disorders (10%), urinary system disorders (5%). 4. The most common clinical symptom was abdominal pain (20%), followed by diarrhea (15%), loose stools (10%), vomiting (10%) and borborygmus (10%). 5. The severity of adverse drug reactions was mostly mild (87.5%), and moderate (12.5%). There was no severe case. Conclusions The adverse events from herbal medicine on children and adolescents were mostly minor, most of them could continue herbal medicines.

• Korean Journal of Clinical Pharmacy
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• v.34 no.1
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• pp.71-78
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• 2024

Background: Oral cancer drugs, particularly tyrosine kinase inhibitors (TKIs), are increasingly popular due to their convenience. However, they pose challenges like drug interactions, especially with medications like azole antifungals. While the FDA provides some guidance, more detailed information is needed to manage these interactions effectively. A meta-analysis was conducted to understand the impact of interactions between TKIs and azole antifungals on adverse events during clinical studies. Methods: A meta-analysis followed PRISMA guidelines. Data from PubMed, EMBASE, and references were searched until November 30, 2021. Inclusion criteria encompassed studies on TKI-antifungal interactions in English. Study selection and quality assessment were conducted by two independent investigators. Results: Out of 158 articles, 11 were selected for analysis. Combination therapy showed a slight increase in adverse events but was not statistically significant (OR 1.02, 95% CI 0.49-2.13, p=0.95). AUC and Cmax fold changes did not significantly impact adverse event development. Both itraconazole and ketoconazole showed no significant difference in adverse event development compared to TKI alone. Conclusions: Study finds TKI-DDI not significantly linked to AE increase; azole antifungal types not related to AE. Future DDI research crucial for drug development.

• Korean Journal of Clinical Pharmacy
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• v.32 no.3
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• pp.204-214
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• 2022

Objective: This study aimed to investigate the occurrence and types of the adverse events (AEs) associated with oral fluconazole and itraconazole and factors associated with specific types of AEs. Methods: We analyzed AEs reported by community pharmacies nationwide over 10 years using the Korea Adverse Event Reporting System database. Various AE terms were categorized into 18 types, and concomitant medications were classified by drug-drug interaction (DDI) severity. The relationship between the specific type of AE and age, sex, and number of concomitant medications was investigated using multiple logistic regression analysis. Results: A total of 879 AE reports of fluconazole and 401 reports of itraconazole were analyzed; of these reports, 321 and 83 reports of fluconazole and itraconazole, respectively, described concomitant drug administration categorized as DDI severity of contraindicated or major. Women had a higher risk of psychiatric AEs associated with fluconazole use (OR, 1.587; p=0.042). Polypharmacy increased the risk for psychiatric AEs (OR, 3.598; p<0.001 for fluconazole and OR, 2.308; p=0.046 for itraconazole). In dermatologic AEs, the mean age of patients who received itraconazole was lower than that of patients who received fluconazole (46.3±16.8 vs. 54.9±15.4; p<0.001). Co-administration of fluconazole with 1-3 drugs increased the risk of neurological AEs (OR, 1.764; p=0.028). Conclusion: When using fluconazole and itraconazole, psychiatric AEs should be noted, particularly in women and in case of polypharmacy; moreover, when fluconazole is co-administered with other drugs, attention should be paid to the occurrence of neurological AEs.

• Korean Journal of Acupuncture
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• v.32 no.4
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• pp.177-189
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• 2015

Objectives : To develop and validate a survey form for adverse events(AEs) associated with acupuncture and moxibustion treatment. Methods : The 1st version of a survey form consisting of 9 categories was developed and modified based on the analysis of questionnaires from previous studies on AEs. To evaluate content validity of the 1st version, a Delphi survey where experts in acupuncture and moxibustion, and research methodology were invited, was conducted alongside a separate content validity questionnaire. The content validity indices for each item and total scale were calculated as the proportion of the number of experts judging each item or scale valid to the number of total experts. Results : After the Delphi round 1, the content validity of 2 items and total scale was rated as inadequate. The 1st version was modified accordingly, and the 2nd version of the survey form was developed. The content validity of the 2nd version was assessed in the Delphi round 2 and the final version was completed after incorporating the expert comments. The final version consists of 13 questions regarding practitioner/patient information, condition/disease, intervention, treated body parts, safety issue and AE occurrence related with practitioner's behavior or instruments, AEs associated with treatment and emergency actions taken if necessary, time to AE occurrence, outcomes, serious AEs or death, and time to AE disappearance. Conclusions : This newly developed and validated survey form will serve to collect AEs associated with acupuncture and moxibustion treatments in Korea and contribute to establishing the evidence on safety of Korean acupuncture treatment.

• The Journal of Korean Medicine
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• v.45 no.1
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• pp.165-181
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• 2024

Objectives: This study was aimed to review the global status of adverse event (AE) reports and the characteristics of the reported AEs of plants managed as herbal medicines (HMs) with toxic precautions in Korea. Methods: This is a cross-sectional quantitative study that analyzed information available through VigiAccess, a website that provides summarized statistical information from the WHO's global AE database to the public. VigiAccess was searched in 8 Jan, 2024. Information on the total number of reports, number of reports by year and continent, and the age and gender of patients were obtained, and the types of frequently reported AEs were also reviewed. Results: Data on the status of report submissions were obtained for a total of 9 HMs including Aconitum ciliare, Aconitum carmichaeli, Arisaema japonicum, Pinellia ternata, Euphorbiae Lathyridis, Croton tiglium, Strychni Ignatii, Strychnons nux-vomica, and Linum usitatissimum. The number of reports per HM was from 1 to 137. The most commonly reported type of AEs were gastrointestinal disorders in most of the HMs, followed by neurological disorders. Serious adverse events were reported only in Strychni Ignatii, Strychnons nux-vomica, and Linum usitatissimum, including one case of death. Conclusions: This study shows the status of reported AEs of botanicals considered as HMs with toxic precautions in Korea based on real world data. However, when interpreting the findings of this study, readers should consider the significant limitations of this study mainly because of the characteristics of the data source.

• Korean Journal of Acupuncture
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• v.25 no.2
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• pp.95-105
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• 2008

Objectives : This study is to establish the appropriate assessment of causalities from adverse events (AEs) which are related to acupuncture treatment. Methods : We assessed thirty AEs which were caused in the early phase trial on concomitant use of acupuncture and herbal medicines. We scored each AE on the questionnaire in Naranjo and SNU algorithm scale which are for drug causality assessment in pharmacoepidemiology. Results : In Naranjo scale, there were consistencies among the evaluators qualitatively with "Probable", "Possible" degree. In reliability test, parameters, such as, gamma and kendall's tau-b revealed the degrees of 73%, and 32%, respectively. There were disaccordant tendency in SNU algorithm scale. Conclusion : A new algorithm which reflects acupuncture properties should be developed and elucidated.

• Pediatric Infection and Vaccine
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• v.7 no.2
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• pp.183-192
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• 2000

Purpose : Adverse events(AE) associated with vaccination have not been systematically monitored in Korea. But since 1994, several deaths after inactivated mouse brain derived Japanese encephalitis vaccine injection arouse the safety problem of immunization in the public, and a evaluation of vaccination program including the effectiveness and safety problem had been started. We have been using MMR vaccine containing Japanese mumps vaccine strains, which are known to be associated with the high rate of adverse events including aseptic meningitis, for the last decade. Methods : We conducted a prospective study of vaccine adverse events associated with MMR vaccine through a tracking system using telephone calls. We followed up 7,594 cases of MMR vaccinees. Results : Reported adverse events included fever, couvulsion, parotitis, and aseptic meningitis. Nine cases of parotitis and seven cases of aseptic meningitis were recognized during follow up period. The incidence of both parotitis and aeptic meningitis was $85.1/10^5$, for Urabe mumps strain. For Hoshino strain, the incidence of parotitis and aseptic meningitis was $158.0/10^5$ and $94.8/10^5$, respectively. Conclusions : The incidence of adverse events was to be a higher than that of natural infection in Korea and was comparable to the results of studies done in other countries.

• Korean Journal of Clinical Pharmacy
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• v.32 no.1
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• pp.1-7
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• 2022

Objective: The purpose of this study was to detect signals of Adverse Events (AEs) after varenicline treatment using spontaneous AEs reporting system in Korea. Methods: This study was conducted by Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD) reported from January 2013 to December 2017 through Korea Adverse Event Reporting System. Signals of varenicline that satisfied the data-mining indices, proportional reporting ratio, reporting odds ratio and information component were defined. The detected signals were checked whether they included in drug labels in South Korea and United States of America (USA). Results: A total number of drug AE reports associated with all drugs in the KIDS-KD reported between January 2013 and December 2017 was 2,665,429. Among them, the number of AE reports associated with varenicline was 1,398. Eighteen meaningful signals of varenicline were detected that satisfied with the criteria of data-mining indices. Finally, two signals such as hypotonia, incorrected dose administered were not included in the drug labels. Conclusion: New AE signals of varenicline that were not listed on the drug labels in South Korea and USA were detected. However, further pharmacoepidemiological studies such as randomized controlled trial are needed to evaluate the causality of the signals of varenicline.