• The Journal of Internal Korean Medicine
• /
• v.30 no.1
• /
• pp.181-190
• /
• 2009

It is important to establish the safety of herbal medicine because of its frequent and widespread use in Korea. Several studies on the safety of herbal medicine have been performed and there have been rare serious adverse drug reactions from those reports in Korea. However, the results are not strongly supported because of not adopting appropriate enough research methodology as to make the safety issue clear. For improving the quality of the safety research on herbal medicine. including investigations of drug induced liver injury (DILl). the aim of this study was to suggest herbal medicine-induced liver injury investigation forms for performing reasonable safety research. After a systematic review of the preceding studies regarding herbal safety in Korea was performed in 2008, we assessed the quality and the limitations of the primary studies. Two investigation forms for herbal safety research were made as a following step. one a basic investigation form for herbal safety research and the other an advanced investigation form for suspected DILl cases, Those forms include the essential informations and data needed to make an appropriate assessment of whether DILl occurred during or after the use of herbal medicine. Guidelines for using those forms and other recommendations were also suggested. More rigorous studies are required for answering the safety issue of herbal medicine as well as the efficacy issue. We hope for wide use and improvement of those investigation forms in the study of herbal safety by many researchers for establishing better evidences in Korea.

• Journal of the Korea Society of Computer and Information
• /
• v.26 no.11
• /
• pp.217-225
• /
• 2021

In this paper, we designed and implemented the integrated system to prevent adverse drug reactions of polypharmacy components in medicine by supporting component-component information and disease-component information, through data queuing algorithm and vast amounts of pharmaceutical big data. In addition, by providing information for drugs, drug components, prohibited drugs, as well as suppliers and distributors, it could help ease anxiety about taking drugs not only for health-care professionals but also for general users. The representative information provided were side effects between two drugs, main components and effectiveness of particular drugs, drugs manufactured by the same pharmaceutical company, and drug component information for patients with chronic diseases. The future work is to update the database by collecting information on rare & new diseases and new drugs.

• Korean Journal of Clinical Pharmacy
• /
• v.22 no.4
• /
• pp.340-346
• /
• 2012

Background: Amphotericin B is a mainstay in the treatment of many systemic fungal infections due to its wide antifungal spectrum and low incidence of resistance. However, the use of amphotericin B is limited by its nephrotoxicity. Objectives: The objective of this study was to evaluate the incidence and risk factors of renal adverse drug reactions (ADRs) of conventional amphotericin B (Fungizone$^{(R)}$). In addition, we compared the changes of serum creatinine (SCr) between patients who remained conventional amphotericin B and patients who were switched to liposomal amphotericin B after occurrence of renal adverse reactions. Methods: Adult hospitalized patients who reported renal adverse reactions caused by conventional amphotericin B from January 2011 to July 2012 at pharmacovigilance center in Yonsei University Healthcare System included in this study. ADRs scored as 'doubtful' in Naranjo probability ADR scale were excluded. We retrospectively analyzed patients' basic clinical characteristics, concurrent diseases or nephrotoxic drugs in order to find variables that can correlate with occurrence of renal ADRs. Changes in SCr were compared between conventional amphotericin B group and liposomal amphotericin B group. Results: A total of 231 ADRs after administration of conventional amphotericin B in 75 patients were reported to pharmacovigilance center and assessed their severities as 'possible', 'probable', or 'definite'. Renal adverse reaction was the most common ADR with incidence rate of 42% (96 of 231 ADRs). Mean change in SCr from baseline was 0.26 mg/dL (change % 37.8) and statistically significant (p=0.000). Simple correlations analysis revealed that the number of concurrent diseases and number of nephrotoxic drugs were positively correlated with changes in SCr, but these results were not statistically significant. Among 43 patients who remained amphotericin B after occurrence of renal ADRs, 27 patients was administered conventional amphotericin B and 16 patients changed to liposomal amphotericin B. Mean change in SCr in amphotericin B group was 0.23 mg/dL (32.75%), whereas mean change in SCr in liposomal amphotericin B group were -0.28 mg/dL (19.38%) and difference between two groups was statistically significant (p=0.003). The numbers of patient with SCr elevation more than 30% were 9 (33.3%) in amphotericin B group and 2 (12.5%) in liposomal amphotericin B group (Odd Ratio=3.50, 95% Confidence Interval 0.65-18.85; p=0.130). Conclusion: An analysis of ADRs due to amphotericin B administration revealed significant mean changes in SCr from baseline. Switching to liposomal amphotericin B showed significant decrease in SCr compared with conventional amphotericin B.

• Korean Journal of Clinical Pharmacy
• /
• v.30 no.3
• /
• pp.143-148
• /
• 2020

Objective: This study aimed to investigate pharmaceutical care for critically ill neonates and suggest targeted strategies compatible with the Korean health-system pharmacy. Methods: Articles that reported pharmacy practices for critically ill neonates were reviewed. Pharmaceutical care practices and roles of neonatal pharmacists were identified, and criteria were developed for neonates in need of specialized care by clinical pharmacists. Results: Neonatal pharmacists play many roles in the overall medication management pathway. For clinical decision support, multidisciplinary ward rounds, clinical pharmacokinetic services, and consultation for pharmacotherapy and nutrition support were conducted. Prevention and resolution of drug-related problems through review of medication charts contributed to medication safety. Pharmaceutical optimization of intravenous medication played an important role in safe and effective therapy. Information on the use of off-label medicine, recommended dosage and dosing schedules, and stability of intravenous medicine was provided to other health professionals. Most clinical practices for neonates in Korea included therapeutic drug monitoring and nutrition support services. Reduction in medication errors and adverse drug reactions, shortening the duration of weaning medicines, decreasing the use and cost of antimicrobials, and improvement in nutrition status were reported as the outcomes of pharmacist-led interventions. The essential criteria of pharmaceutical care, including for patients with potential high-risk factors for drug-related problems, was developed. Conclusion: Pharmaceutical care for critically ill neonates varies widely. Development and provision of standardized pharmaceutical care for Korean neonates and a stepwise strategy for the expansion of clinical pharmacy services are required.

• Journal of Sasang Constitutional Medicine
• /
• v.26 no.2
• /
• pp.205-212
• /
• 2014

Objectives Adverse reactions can becaused by contrast media used in computed tomography. The aim of this study was to report the improvement of allergic response caused by contrast media after treatment with Modified Hyeongbangpaedok-san, histamine antagonists and steroids. Methods We retrospectively reviewed the medical records. The patient's subjective symptoms such as rash and pruritus were evaluated by the range of rash and numeric rating scale(NPS). Results All symptoms showed nearly complete remission with continued Korean traditional medical treatment. Conclusions A female patient had been injected with contrast media for Computed tomography(CT) evaluation of lung cancer. Rash and pruritus appeared 1 day after injection. We prescribed Modified Hyeongbangpaedok-san. Patients were treated with both Korean medicine and Western medicine. Consequently, the symtoms were improved significantly after combination treatment of Korean medicine and Western medicine.

• Journal of Korean Neurosurgical Society
• /
• v.56 no.5
• /
• pp.448-450
• /
• 2014

Nefopam, a centrally acting analgesic, has been used to control postoperative pain. Reported adverse effects are anticholinergic, cardiovascular or neuropsychiatric. Neurologic adverse reactions to nefopam are confusion, hallucinations, delirium and convulsions. There are several reports about fatal convulsive seizures, presumably related to nefopam. A 71-year-old man was admitted for surgery for a lumbar spinal stenosis. He was administered intravenous analgesics : ketorolac, tramadol, orphenadrine citrate and nefopam HCl. His back pain was so severe that he hardly slept for several days; he even needed morphine and pethidine. At 4 days of administration of intravenous analgesics, the patient suddenly started generalized tonic-clonic seizures for 15 seconds, and subsequently, status epilepticus; these were not responsive to phenytoin and midazolam. After 3 days of barbiturate coma therapy the seizures were controlled. Convulsive seizures related to nefopam appear as focal, generalized, myoclonic types, or status epilepticus, and are not dose-related manifestations. In our case, the possibility of convulsions caused by other drugs or the misuse of drugs was considered. However, we first identified the introduced drugs and excluded the possibility of an accidental misuse of other drugs. Physicians should be aware of the possible occurrence of unpredictable and serious convulsions when using nefopam.

• Genomics & Informatics
• /
• v.16 no.3
• /
• pp.52-58
• /
• 2018

In this report, we present a case study of how pharmacogenomics and pharmacometabolomics can be useful to characterize safety and pharmacokinetic profiles in early phase new drug development clinical trials. During conducting a first-in-human trial for a new molecular entity, we were able to determine the mechanism of dichotomized variability in plasma drug concentrations, which appeared closely related to adverse drug reactions (ADRs) through integrated omics analysis. The pharmacogenomics screening was performed from whole blood samples using the Affymetrix DMET (Drug-Metabolizing Enzymes and Transporters) Plus microarray, and confirmation of genetic variants was performed using real-time polymerase chain reaction. Metabolomics profiling was performed from plasma samples using liquid chromatography coupled with quadrupole time-of-flight mass spectrometry. A GSTM1 null polymorphism was identified in pharmacogenomics test and the drug concentrations was higher in GSTM1 null subjects than GSTM1 functional subjects. The apparent drug clearance was 13-fold lower in GSTM1 null subjects than GSTM1 functional subjects (p < 0.001). By metabolomics analysis, we identified that the study drug was metabolized by cysteinylglycine conjugation in GSTM functional subjects but those not in GSTM1 null subjects. The incidence rate and the severity of ADRs were higher in the GSTM1 null subjects than the GSTM1 functional subjects. Through the integrated omics analysis, we could understand the mechanism of inter-individual variability in drug exposure and in adverse response. In conclusion, integrated multi-omics analysis can be useful for elucidating the various characteristics of new drug candidates in early phase clinical trials.

• Asian Pacific Journal of Cancer Prevention
• /
• v.13 no.4
• /
• pp.1209-1215
• /
• 2012

Background and Aim: Oxaliplatin hypersensitivity is a well-known adverse reaction but the prevalence varies and data for frequency and clinical features have not been reported for Korea. Here we evaluates the prevalence and risk factors for hypersensitivity reactions to oxaliplatin after chemotherapy. Methods: Clinical information on all patients treated with oxaliplatin was retrospectively reviewed in electronic medical records between August 2009 and July 2010 in Seoul National University Bundang Hospital. Patients who experienced hypersensitivity reactions to oxaliplatin were compared with those who did not. Results: A total of 393 patients received oxaliplatin, with 42 (10.7%) experiencing hypersensitivity reactions including three cases of anaphylaxis. Median cycle of the first hypersensitivity reaction was 8. Reactions correlated with lower dexamethasone doses. Other variables were not significant. Conclusions: The prevalence of hypersensitivity reactions was 10.7%, symptoms being mostly mild and cutaneous. Lower dexamethasone doses could be a predictor for hypersensitivity reactions to oxaliplatin.

• Journal of Ginseng Research
• /
• v.42 no.4
• /
• pp.571-576
• /
• 2018

Background: Korean Red Ginseng (KRG) has been used in Asia for its various biological effects, but no studies have investigated the safety of its long-term intake. Therefore, the present study evaluated the safety of KRG intake for 24 weeks. Methods: We randomized 1,000 participants in a 1:1 ratio into two groups, which were treated daily with 2 g of KRG or a placebo for 24 weeks. The primary endpoint was all adverse events and adverse drug reactions (ADRs) that occurred after KRG or placebo administration, which were reported at week 4, 12, and 24 after the baseline visit. Results: In total, 192 and 211 participants experienced adverse events in the KRG and placebo groups (39.2% and 42.0%, respectively; p = 0.361), and 59 and 57 KRG- and placebo-treated individuals reported ADRs (12.0% and 11.4%, respectively; p = 0.737). The frequently occurring ADRs were pruritus (2.0%), headache (1.6%), diarrhea (1.4%), and dizziness (1.2%) in the KRG group and pruritus (2.0%), headache (1.8%), dizziness (1.6%), rash (1.4%), and diarrhea (1.2%) in the placebo group. Discontinuation of drug administration due to ADRs was reported in 13 participants, six (1.2%) and seven (1.4%) in the KRG and placebo groups, respectively (p = 0.814). No significant abnormal changes were revealed by anthropometric, laboratory, and vital sign measurements in the KRG group compared with those in the placebo group. Conclusion: The present study confirms the safety and tolerability of daily intake of 2 g of KRG for 24 weeks by healthy adults.

• Korean Journal of Clinical Pharmacy
• /
• v.34 no.2
• /
• pp.100-107
• /
• 2024

Background: The purpose of this study was to detect signals of adverse events (AEs) of DPP-IV inhibitors using the KIDs-Korea Adverse Event Reporting System (KAERS) database. Methods: This study was conducted using AEs reported from January 2009 to December 2018 in the KIDs-KAERS database. For signal detection, disproportionality analysis was performed. Signals of DPP-IV inhibitor that satisfied the data-mining indices of reporting odds ratio (ROR) were detected. Results: Among the total number of 10,364 AEs to all oral hypoglycemic agents, the number of reported AEs related to DPP-IV inhibitors was 1,674. Analysis of reported AEs of DPP-IV inhibitors at the SOC levels showed that Respiratory system disorders were the highest at 4.31 (95% CI 3.01-6.17), followed by Skin and appendages disorders at 2.04 (95% CI 1.74-2.38). When analyzing AEs reported at the PT level, pharyngitis was the highest at 73.90 (95% CI 17.59-310.49), followed by arthralgia at 6.08 (95% CI 2.04-18.11), and coughing at 5.21 (95% CI 2.07-13.15). Conclusions: Based on the result of the study, deeper consideration is required according to the characteristics of the patients in prescribing DPP-IV inhibitors among oral hypoglycemic agents, and continuous monitoring of the occurrence of related Adverse Drug Reactions during administration is also required.