• Journal of The Korean Society of Clinical Toxicology
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• v.13 no.2
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• pp.103-110
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• 2015

Purpose: The purpose of this study is to evaluate the effectiveness and the adverse events of high dose insulin/euglycemia therapy in acute calcium channel blocker (CCB) poisoning. Methods: We developed a systematic search strategy and applied it to 4 electronic reference databases. We searched medical journals as well as the bibliographies of relevant articles. All forms of literature relevant to human use of high dose insulin for acute CCB poisoning were included. The literature search was conducted by two investigators in August, 2015 with publication language restricted to English and Korean. Case reports were divided between CCB overdose alone and multi-drug overdose including CCB. The effect and adverse event of high dose insulin and clinical outcome of each case were analyzed. Results: Among 55 searched studies, 20 studies were included. A prospective study, a retrospective study, a systematic review study, and 17 case reports were identified. Case reports consisted of 11 CCB alone and 12 multidrug overdose cases including CCB. Although most cases described significant clinical improvements, one of them showed no beneficial effect. Several adverse events including hypoglycemia and hypokalemia were reported. No significant sequalae from adverse events was reported. Conclusion: Although there were many case reports demonstrating successful use of high dose insulin for CCB poisoning, the effect cannot be estimated due to a possibility of publication bias. Therefore, high dose insulin/euglycemia therapy might be considered adjunctive therapy in cases of CCB intoxication refractory for standard therapy.

• Korean Journal of Clinical Pharmacy
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• v.25 no.3
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• pp.171-177
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• 2015

Background: Androgenetic alopecia (AGA), one of alopecias, requires continuous treatment in order to prevent or stop it, and patient's compliance is very important. Currently, only two drugs (finasteride, minoxidil) have been approved for AGA by Food and Drug Administration of United States (US FDA). However, another ${\alpha}-2$ reductase inhibitor, dutasteride, is approved by Korea Ministry of Food and Drug Safety (MFDS) through a phase III trial. For treatment, pharmacotherapy of AGA usually combines topical minoxidil 7% with one of oral <${\alpha}-2$ reductase inhibitor. Objectives: We evaluated the comparative efficacy and adverse effect between topical minoxidil 7%/finasteride 1 mg and topical minoxidil 7%/dutasteride 0.5 mg pharmacotherapy for outpatients with AGA. Also we evaluated the relationship between therapeutic effect and regular hospital visit. Method: This study was performed retrospectively based on electronic medical record (EMR) data of total 98 patients (topical minoxidil 7% with dutasteride 0.5 mg ($Avodart^{(R)}$) or finasteride 1 mg ($Alopecia^{(R)}$, $Propecia^{(R)}$) with diagnosis of AGA from department of dermatology at a secondary hospital from January $1^{st}$, to May $31^{st}$, 2014. Results: The efficacy and adverse event of topical minoxidil 7%/dutasteride 0.5 mg (DUTA group) were 100% and 45.7%, and of topical minoxidil 7%/finasteride 1 mg (FINA group) were 92.1% and 33.3%, respectively. The mean onset time of responses and adverse events in the FINA group were 3.86 months and 4.43 months. Those in the DUTA group were 3.97 months and 5.06 months. Conclusion: Both FINA and DUTA group were highly effective, but the DUTA group showed higher efficacy and adverse effects than those in the FINA group. Dutasteride may be another alternative in AGA treatment.

• Korean Journal of Clinical Pharmacy
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• v.25 no.1
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• pp.56-58
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• 2015

Summary: We report the first hepatic adverse effect of tosufloxacin tosylate in a muscle invasive bladder cancer patient with normal liver functions and with scheduling to undergo a surgical operation for a neobladder. Tosufloxacin tosylate 150 mg was administered to a 57-year-old man who maintained transurethral resection of bladder tumor (TUR-BT) postoperative multiple medications. His labs presented significant increases in alanine amino transferase (ALT) and aspartate amino transferase (AST) levels with 2-week compliance of 150 mg tablet three times a day. After discontinuing tosufloxacin tosylate, the levels slowly decreased and completely returned to normal ranges without any intervention in a few weeks. The Naranjo Causality Algorithm indicates a probable relationship between increased ALT and tosufloxacin. The patient was to have the second surgical operation as scheduled after getting normal range of ATL level. Therefore, tosufloxacin should be avoided in patients at risk for having liver dysfunctions or diseases if the patients have a schedule for any operation. Background: Tosufloxacin tosylate has been shown to have favorable benefits as an antibiotic. Tosufloxacin tosylate may be considered to have the adverse effects such as nauseas, vomiting, diarrhea, abdominal pain, stomatitis, tendonitis, tendon rupture, headache, dizziness, drowsiness, insomnia, weakness, agitation including hemolysis in the event of glucose-6-phosphate dehydrogenase deficiency as other fluoroquinolones. More severe adverse reactions of tosufloxacin tosylate over the above common adverse effects of fluoroquinolones were thrombocytopenia and nephritis. It also is not well known that tosufloxacin can cause hepatic problem. Here the study reports the first hepatic reaction from tosufloxacin and might arouse heath care providers' attention to appropriate drug choice for patients.

• The Journal of Korean Medicine
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• v.36 no.1
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• pp.45-60
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• 2015

Objectives: The purpose of this study was to understand the status of reporting and characteristics of adverse drug reactions (ADRs) induced by herbal drugs and to make a suggestion for the domestic pharmacovigilance system on herbal medicine. Methods: We carried out a hospital-based observational study at Dongguk University Ilsan Oriental Hospital from April 2012 to December 2014. We reviewed all the herbal-drug-associated ADRs reports registered to the spontaneous ADR reporting system in electronic medical records of the hospital in the period. Results: We found out 101 reports including 163 herbal-drug-associated ADRs from 97 patients. Females (69.3%) outnumbered males and the most frequent age group was the 50s (44, 27.0%). No serious adverse event was observed. The most commonly reported ADR was gastro-intestinal system disorders (68, 41.5%) followed by skin-related disorders (42, 25.8%). Diarrhea (29, 17.8%) was the most frequently referred clinical manifestation. Most ADRs were induced by internal medicines (160, 98.2%) including manufactured (36, 22.1%) and self-prepared decoction (160, 76.1%). The pairs of Igi-hwan-diarrhea, gamiboa-tang-vomiting, and Magnoliae Flos-gastro-intestinal-system-related ADRs were observed twice each and the others appeared only once. Conclusions: We propose Korean government to take an initiative in national pharmacovigilance system for herbal medicine. To perform the surveillance on herbal drugs, the Association of Korean Medicine (AKOM) should set up a nationwide network by designating centers connecting the Korean medical hospitals, local Korean medicine clinics, and the public health centers. The government and AKOM should also educate and encourage them to understand the pharmacovigilance system and report the ADRs actively.

• Korean Journal of Acupuncture
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• v.29 no.1
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• pp.1-15
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• 2012

Objectives : This research was projected to verify the validities of needling or moxibustion- acupoints in Illustrated Manual for the Practice of Acupuncture and Moxibustion with the Help of a Bronze Figure bearing Acupuncture Points (IMPAM) and The Classic of Supplementing Life with Acupuncture and moxibustion(CSLAM) Methods; We investigated acupoints which have prohibitions, notices or adverse events when performing needling or moxibustion in IMPAM and CSLAM, then verified it in various literatures and today's medical knowledge. Results; In IMPAM, 2 acupoints were prohibited both needling and moxibustion, 22 acupoints were prohibited from needling and 29 were prohibited from moxibustion. In CSLAM, 3 acupoints were prohibited from both needling and moxibustion, 24 acupoints were prohibited from needling and 31 were prohibited from moxibustion. Most of the prohibition, the notices and adverse events of the acupoints written in IMPAM and CSLAM had medical or philological bases, and the number of them increased compared to that in A-B Classic of Acupunture and Moxibustion(ABCAM). Conslusion : The prohibotions, the notices and the adverse events when performing acupunture or moxibustion in IMPAM and CSLAM reflected the medical experience and knowledge of the time. And the knowledge was increased compared to that in ABCAM.

• Korean Journal of Acupuncture
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• v.36 no.3
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• pp.150-161
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• 2019

Objectives : The authors aimed at contributing to the safety of acupuncture in the clinic by analyzing the information of contraindicated acupoints described in Uihakipmun. Methods : We investigated the contents related acupuncture contraindications in Uihakipmun, categorized the contraindicated acupoints by site and identified whether they can cause adverse events from the anatomical point of view. Results : In Uihakipmun, 49 acupoints - BL6, BL8, BL9, ST1, SI18, BL1, BL2, TE18, TE19, TE20, GB1, GB3, GV22, GV24, ST12, ST9, TE16, GV6, BL15, BL30, CV17, LU2, GB22, SP16, CV8, CV9, CV15, KI11, ST30, SP11, BL56, GB32, GB33, GB42, LI13, HT2, TE8, GV17, GB18, EX-HN11, GB21, GV11, GV10, ST17, CV5, CV1, ST42, SP6, LI4 - were described as contraindicated acupoints. Among them, the contraindications induced by acupuncture treatment were described for just 5 acupoints. Anatomically, acupuncture stimulation at the contraindicated acupoints can cause organ, nerve or vessel damage near the acupoints. And the number of contraindicated acupoints in Uihakipmun was increased compared to those in Hwangjenaegyeong, Chimgugabeulgyeong, Bigeupcheongeumyobang, Donginsuhyeolchimgudogyeong and Chimgujasaenggyeong. Conclusions : In Ming dynasty, the knowledge associated with adverse events on acupuncture was increased by the accumulation of medical knowledge. Acupuncture stimulation at the contraindicated acupoints described in Uihakipmun can cause tissue damage, therefore we should perform acupuncture procedure carefully to avoid adverse events when stimulating the contraindicated acupoints.

• Korean Journal of Clinical Pharmacy
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• v.28 no.4
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• pp.293-299
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• 2018

Background: 3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) effectively reduce serum levels of low-density lipoprotein (LDL) and total cholesterol. High-intensity statins are recommended for all patients aged ${\leq}75$ with clinical atherosclerotic cardiovascular disease (ASCVD), diabetes mellitus aged 40-75 with ${\geq}7.5%$ estimated 10-year ASCVD risk and LDL-C ${\geq}190mg/dL$. High-intensity statins associated with more frequent adverse events (AEs) compared to moderate- to low-intensity statins. The aim of this study was to compare AEs between high-intensity and moderate- to low-intensity statin group using the Korea Adverse Event Reporting System (KAERS) database. Methods: Adults (${\geq}18years$) with statin-associated AEs from July 2009-June 2014 were included. Only AEs classified as "certain", "probable" and "possible" based on the WHO-Uppsala Monitoring Center criteria were analyzed. Results: In total, 247 AEs from 196 patients [high-intensity statin group (HG), n = 25 (13%); moderate- to low-intensity statin group (MLG), n = 171 (87%)] were included. Mean age was higher in HG compared with MLG ($67{\pm}14$ vs $62{\pm}12$). The HG showed a significant higher frequency of liver/biliary system disorders (37% vs 14%, p = 0.001). Hepatic function abnormal was reported more frequently in HG compared to MLG (26% vs 9%, p = 0.006). Conclusion: According to KAERS data, liver/biliary system disorders were more frequently reported in HG compared to MLG.

• 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.

• Childhood Kidney Diseases
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• v.27 no.1
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• pp.34-39
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• 2023

Purpose: This article was to collect data on the safety of coronavirus disease 2019 (COVID-19) vaccines in children with underlying medical conditions. Methods: We constructed a prospective cohort of children and adolescents aged 5 to 19 years who had received at least one dose of COVID-19 vaccine. Patients diagnosed with and treated for chronic kidney disease, autoimmune disease, or other chronic conditions at the Seoul National University Children's Hospital were recruited from June to December 2022. A mobile survey questionnaire was sent to their guardians. The presence of adverse events on the day (day 0), 3 weeks (day 21), and 6 months (day 180) after the 1st dose of COVID-19 vaccine was recorded by the guardians. Results: A total of 73 children participated. The median age was 14 years, and 64.4% of the patients were male. On the day of immunization, 65.8% of the patients reported at least one adverse event. Pain at the injection site, fatigue, headache, arthralgia, and myalgia were the most common symptoms. The prevalence of adverse events decreased over time (65.8% on day 0, 27.4% between days 0 and 21, and 24.6% between days 21 and 180). Severe acute respiratory syndrome coronavirus 2 infection after the 1st dose occurred in 17 patients (23.3%) and one of the patients (5.88%) was hospitalized due to infection. Conclusions: Adverse events after COVID-19 vaccination were generally mild in children and adolescents with underlying medical conditions. Our findings provide evidence for the safety of COVID-19 vaccination in the vulnerable pediatric population.

• Journal of the Institute of Electronics Engineers of Korea SC
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• v.48 no.5
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• pp.74-80
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• 2011

Medical implant devices are one of the targets of the US's Food & Drug Administration (FDA) for tracking in case of a serious adverse event since they are directly connected to the lives of patients. The US law stipulates that the public health agency shall order implantable device makers to track their product down to the patient level if a serious adverse event has occurred or defects have been discovered; in reality, however, the agency can pass on the responsibility for tracking or recalling faulty devices to the manufacturers or use mass media. This article proposes an efficient tracking and recall management system and examines four main virtual scenarios based on such. This research seeks to suggest a system that enables FDA to perform accurate and prompt tracking and recall management for patients' enhanced safety.