• 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.

• 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.

• 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.

• Journal of Korean Medicine Rehabilitation
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• v.30 no.2
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• pp.153-164
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• 2020

Objectives This study is designed to evaluate the safety of Soshihotang soft extract in healthy male volunteers. Methods 12 healthy male volunteers were recruited and this study was carried out by a single center. Laboratory test results, vital signs of the volunteers were collected to evaluate safety. According to registration order, the 12 subjects were allocated by serial number. To evaluate safety, blood samples were taken and vital signs were checked 4 times-screening, pre administration, post administration and follow up-during the whole trial. The incidence of all adverse effects are shown in percentage. The mean and standard deviation were used to to describe and summarize continuous data. To evalate the effectiveness of the intervention, data of blood tests was analyzed by Wilcoxon signed rank test or paired T-test (p<0.05). Results In the case of red blood cell, hemoglobin, hematocrit, neutrophils, protein, albumin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, γ-glutamyl transpeptidase values, the normality test result of the variable for the difference value before and after the dosing has a significance level <0.05. But most of values did not deviate from the normal range, and the deviation from the normal range could not be regarded as the significance associated with this clinical trial. And adverse event wasn't observed associated with the clinical trial drug. Conclusions Soshihotang soft extract were considered to be safe for healthy male volunteers.

• Journal of Yeungnam Medical Science
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• v.40 no.3
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• pp.293-296
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• 2023

Oral mucosal burns can occur after contact with various chemical agents, and commonly manifest as areas of mucosal sloughing and ulceration. Policresulen (Albothyl, Celltrion Pharm Inc.) is an over-the-counter topical antiseptic that is frequently used to treat stomatitis. Policresulen solution is highly acidic, with an approximate pH of 0.6; it can thus cause mucosal injury when improperly applied in the oral cavity. Here, we present a rare case of an oral mucosal burn resulting from incorrect self-administration of policresulen and emphasize the importance of increasing understanding of this adverse drug event among consumers and health professionals.

• Tuberculosis and Respiratory Diseases
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• v.78 no.4
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• pp.321-325
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• 2015

Background: The adverse effects of the phosphodiesterase-4 inhibitor roflumilast, appear to be more frequent in clinical practice than what was observed in chronic obstructive pulmonary disease (COPD) clinical trials. Thus, we designed this study to determine whether adverse effects could be reduced by starting roflumilast at half the dose, and then increasing a few weeks later to $500{\mu}g$ daily. Methods: We retrospectively investigated 85 patients with COPD who had taken either $500{\mu}g$ roflumilast, or a starting dose of $250{\mu}g$ and then increased to $500{\mu}g$. We analyzed all adverse events and assessed differences between patients who continued taking the drug after dose escalation and those who had stopped. Results: Adverse events were reported by 22 of the 85 patients (25.9%). The most common adverse event was diarrhea (10.6%). Of the 52 patients who had increased from a starting dose of $250{\mu}g$ roflumilast to $500{\mu}g$, 43 (82.7%) successfully maintained the $500{\mu}g$ roflumilast dose. No difference in factors likely to affect the risk of adverse effects, was detected between the dose-escalated and the discontinued groups. Of the 26 patients who started with the $500{\mu}g$ roflumilast regimen, seven (26.9%) discontinued because of adverse effects. There was no statistically significant difference in discontinuation rate between the dose-escalated and the control groups (p=0.22). Conclusion: Escalating the roflumilast dose may reduce treatment-related adverse effects and improve tolerance to the full dose. This study suggests that the dose-escalated regimen reduced the rate of discontinuation. However, longer-term and larger-scale studies are needed to support the full benefit of a dose escalation strategy.

• Korean Journal of Radiology
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• v.22 no.8
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• pp.1310-1322
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• 2021

Immunotherapy is an effective treatment option for gynecological malignancies. Radiologists dealing with gynecological patients undergoing treatment with immune checkpoint inhibitors should be aware of unconventional immune-related imaging features for the evaluation of tumor response and immune-related adverse events. In this paper, immune checkpoint inhibitors used for gynecological malignancies and their mechanisms of action are briefly presented. In the second part, patterns of pseudoprogression are illustrated, and different forms of immune-related adverse events are discussed.

• Journal of Korean Medicine Rehabilitation
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• v.29 no.1
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• pp.63-73
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• 2019

Objectives The purpose of this study is to evaluate the safety of Ojeok-san extract powder and soft extract in healthy male volunteers. Methods Randomized controlled, cross over study was carried out in healthy male volunteers. Total 27 of 31 subjects meeting the inclusion criteria were enrolled and three subjects for waiting were included. To each group 12 subjects were randomly allocated by random number table. Group A took the extract powder in the first period and then took the soft extract in the second period. Group B took the medicine in the opposite order. Trial was conducted through two times of hospitalizations and all subjects had a seven-days of wash out period. Vital sign and laboratory test were checked before and after the medication. The mean difference of safety evaluation variables were analyzed by paired t-test (p<0.001) or wilcoxon signed rank test (p<0.05). The mean difference between two groups were analyzed by independent t-test (p<0.05) or Mann whitney test (p<0.05). Results As a result of all data related to vital sign and laboratory test in both group, There were no significant differences associated with the clinical trial drug between before and after the medication. And there was no adverse event associated with the clinical trial drug. Conclusions Both Ojeok-san extract powder and soft extract were found to be safe for healthy male volunteers.

• Clinical and Experimental Pediatrics
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• v.59 no.1
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• pp.35-39
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• 2016

Purpose: This study compared the efficacy and tolerability of intravenous (i.v.) phenobarbital (PHB) and i.v. levetiracetam (LEV) in children with status epilepticus (SE) or acute repetitive seizure (ARS). Methods: The medical records of children (age range, 1 month to 15 years) treated with i.v. PHB or LEV for SE or ARS at our single tertiary center were retrospectively reviewed. Seizure termination was defined as seizure cessation within 30 minutes of infusion completion and no recurrence within 24 hours. Information on the demographic variables, electroencephalography and magnetic resonance imaging findings, previous antiepileptic medications, and adverse events after drug infusion was obtained. Results: The records of 88 patients with SE or ARS (median age, 18 months; 50 treated with PHB and 38 with LEV) were reviewed. The median initial dose of i.v. PHB was 20 mg/kg (range, 10-20 mg/kg) and that of i.v. LEV was 30 mg/kg (range, 20-30 mg/kg). Seizure termination occurred in 57.9% of patients treated with i.v. LEV (22 of 38) and 74.0% treated with i.v. PHB (37 of 50) (P=0.111). The factor associated with seizure termination was the type of event (SE vs. ARS) in each group. Adverse effects were reported in 13.2% of patients treated with i.v. LEV (5 of 38; n=4, aggressive behavior and n=1, vomiting), and 28.0% of patients treated with i.v. PHB (14 of 50). Conclusion: Intravenous LEV was efficacious and safe in children with ARS or SE. Further evaluation is needed to determine the most effective and best-tolerated loading dose of i.v. LEV.

• Journal of the Institute of Electronics and Information Engineers
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• v.52 no.1
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• pp.140-147
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• 2015

In this study, medical devices safety information reporting system was designed to manage medical devices for the efficient management of in-hospital adverse events. The current management of medical device adverse event reporting regulations and the legal status of the system and procedures for identifying the system were reviewed. MSF/CD(Microsoft Solution Framework/Component Design) was applied to the system design. Through this study, we can understand medical devices management including the notice provisions of the Ministry of Food and Drug Safety for medical devices safety information reporting. We also expect this study will help to improve patient safety and the effective management of medical equipment, and contribute to activating medical devices safety information reporting.