• 한국임상약학회지
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• 제33권2호
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• pp.86-96
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• 2023

Background: Using KIDS-KAERS database (KIDS-KD) from 2016 to 2020, the aim is to investigate signals of adverse events of alpha-adrenoceptor antagonists and to present adverse events that are not included in the precautions for use when marketing approval. Methods: This study was conducted by disproportionality analysis. Data mining analysis was performed to detect signals of alpha-adrenoceptor antagonists, such as terazosin, doxazosin, alfuzosin, silodosin, and tamsulosin. The signal was defined by three criteria as proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). Detected signals were compared with product labeling and the European Medicines Agency-Important Medical Events list. Results: Out of the total number of 408,077 reports for adverse events, 6,750 cases were reported as adverse events of alpha-adrenoceptor antagonists. Dizziness, mouth dryness, hypotension postural, and oedema peripheral are identified as common adverse events of five alpha-adrenoceptor antagonists and are typically listed on drug labels. However, new signals were detected for pneumonia, chronic obstructive airway disease, eye diseases such as glaucoma and cataracts, fracture, and ileus of tamsulosin that were not previously listed on the drug labels in Korea. Conclusions: This study identified signals related to adverse drug reactions of alpha-adrenoceptor antagonists and presented serious adverse events, suggesting new adverse reactions to be aware of when using alpha-adrenoceptor antagonists.

• 한국임상약학회지
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• 제32권4호
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• pp.352-361
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• 2022

Objective: This study aimed to analyze the important medical adverse events (IMEs) of cyclosporine and tacrolimus using the reports in US FDA adverse event reporting system (FAERS) and to detect related signals. Methods: The FAERS database was used to analyze the IMEs reported for cyclosporine or tacrolimus during 2017-2021. Reporting odds ratio (ROR) and information component were used to analyze signals for adverse events of both drugs. It was investigated whether the detected signals were present on drug labels in Korea and the United States. Results: Among the total 24,688 reports, the reports on tacrolimus accounted 75.8%. Mean age of the patients was 47.9 years old and median number of adverse events was 2.0 per report. The number of patients hospitalized for adverse events was 7,979 (25.3%). Among the adverse reactions reported on the cyclosporine and tacrolimus, 576 and 1,363 events were detected as signals for cyclosporine and tacrolimus, respectively, and of these, IMEs accounted for 44.8 and 59.2%, respectively. The IMEs related with infections/infestations, renal/urinary disorders, and blood and lymphatic system disorders were reported frequently for both drugs. The most frequently detected IMEs were renal impairment for cyclosporine and acute kidney injury for tacrolimus. Among the top 3 IMEs for each reported SOC for cyclosporine and tacrolimus, 9 and 2 unexpected adverse events were identified, respectively. Conclusion: This study identified the IMEs and signals of cyclosporine and tacrolimus, and detected unidentified adverse events in a drug information database.

• 한국임상약학회지
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• 제32권3호
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• pp.226-237
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• 2022

Background: Monoclonal antibodies for the treatment of patients with different types of cancer, such as cetuximab, have been widely used for the past 10 years in oncology. Although drug information package insert contains some representative adverse events which were observed in the clinical trials for drug approval, the overall adverse event patterns on the real-world cetuximab use were less investigated. Also, there have been no published papers that deal with the full spectrums of adverse drug events of cetuximab using national-wide drug safety surveillance systems. Methods: In this study, we detected new adverse event signals of cetuximab in the Korea Adverse Event Reporting System (KAERS) by utilizing proportional reporting ratios, reporting odds ratios, and information components indices. Results: The KAERS database included 869,819 spontaneous adverse event reports, among which 2,116 reports contained cetuximab. We compared the labels of cetuximab among the United States, European Union, Australia, Japan, and Korea to compare the current labeling information and newly detected signals of our study. Some of the signals including hyperkeratosis, tenesmus, folliculitis, esophagitis, neuralgia, disseminated intravascular coagulopathy, and skin/throat tightness were not labeled in the five countries. Conclusion: We identified new signals that were not known at the time of market approval.

• Journal of Dental Anesthesia and Pain Medicine
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• 제20권3호
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• pp.107-118
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• 2020

Chloral hydrate is the oldest and most common sedative drug used in moderate sedation for pediatric dental patients. Hence, the purpose of this article is to review the safety and possible adverse events of this drug when used for pediatric dental treatment. A bibliographic search in PubMed, MEDLINE, Cochrane Library and KMbase, KISS, DBpia, KoreaMed, and RISS databases was performed. Using the keywords "dental sedation," "chloral hydrate," and "children or adolescent," 512 scientific articles were found. Subsequently, 183 studies were individually assessed for their suitability for inclusion in this literature review. Altogether, 24 studies were selected. They included 12 cases of death before, during, or after chloral hydrate sedation for dental treatment, majorly due to dosing error and use of multiple sedatives. Additionally, intraoperative adverse events were mostly respiratory problems such as hypoxia and apnea, but most events were temporary. After treatment, prolonged sedation, including excessive sleep and less activity were the most common postoperative adverse events, and even death cases were reported. Despite the wide acceptance of chloral hydrate as a sedative-hypnotic agent, the risk of adverse events and adequate dose should be of great concern when using it for pediatric dental sedation.

• 한국임상약학회지
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• 제31권4호
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• pp.324-331
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• 2021

To investigate signals of adverse drug reactions of finasteride by using the Korea Adverse Events Reporting System (KAERS) database. This pharmacovigilance was based on the database of the drug-related adverse reactions reported spontaneously to the KAERS from 2013 to 2017. This study was conducted by disproportionality analysis. Data mining analysis was performed to detect signals of finasteride. The signal was defined by three criteria as proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). The signals of finasteride were compared with those of the other drugs; dutasteride (similar mechanism of action), minoxidil (different mechanism but similar indications for alopecia), silodosin (different mechanism but similar indications for BPH). It was examined whether the detected signals exist in drug labels in Korea. The total number of adverse event-drug pairs was reported 2,665,429 from 2013 to 2017, of which 1,426 were associated with finasteride. The number of investigated signals of finasteride was 42. The signals that did not include in the drug label were 29 signals, including mouth dry, hypotension, dysuria etc. The signal of finasteride was similar to that of dutasteride and silodosin but was different to that of minoxidil. Early detection of signals through pharmacovigilance is important to patient safety. We investigated 29 signals of finasteride that do not exist in drug labels in Korea. Further pharmacoepidemiological studies should be needed to evaluate the signal causality with finasteride.

• International Journal of Heart Failure
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• 제6권2호
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• pp.76-81
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• 2024

Background and Objectives: Real-world clinical data, outside of clinical trials and expert centers, on adverse events related to the use of SyncCardia total artificial heart (TAH) remain limited. We aim to analyze adverse events related to the use of SynCardia TAH reported to the Food and Drug Administration (FDA)'s Manufacturers and User Defined Experience (MAUDE) database. Methods: We reviewed the FDA's MAUDE database for any adverse events involving the use of SynCardia TAH from 1/01/2012 to 9/30/2020. All the events were independently reviewed by three physicians. Results: A total of 1,512 adverse events were identified in 453 "injury and death" reports in the MAUDE database. The most common adverse events reported were infection (20.2%) and device malfunction (20.1%). These were followed by bleeding events (16.5%), respiratory failure (10.1%), cerebrovascular accident (CVA)/other neurological dysfunction (8.7%), renal dysfunction (7.5%), hepatic dysfunction (2.2%), thromboembolic events (1.8%), pericardial effusion (1.8%), and hemolysis (1%). Death was reported in 49.4% of all the reported cases (n=224/453). The most common cause of death was multiorgan failure (n=73, 32.6%), followed by CVA/other non-specific neurological dysfunction (n=44, 19.7%), sepsis (n=24, 10.7%), withdrawal of support (n=20, 8.9%), device malfunction (n=11, 4.9%), bleeding (n=7, 3.1%), respiratory failure (n=7, 3.1%), gastrointestinal disorder (n=6, 2.7%), and cardiomyopathy (n=3, 1.3%). Conclusions: Infection was the most common adverse event following the implantation of TAH. Most of the deaths reported were due to multiorgan failure. Early recognition and management of any possible adverse events after the TAH implantation are essential to improve the procedural outcome and patient survival.

• 대한한방소아과학회지
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• 제28권3호
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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.

• International journal of thyroidology
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• 제11권2호
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• pp.75-77
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• 2018

Tyrosine kinase inhibitor is known to prolong progression free survival in radioiodine refractory thyroid cancer patients. Fatigue/asthenia/malaise is one of most common adverse events by the tyrosine kinase inhibitor treatment, and management of the adverse event is important to keep the drug medication longer which is essential for the survival benefit. In the case report, a radioiodine refractory thyroid cancer patient receiving tyrosine kinase inhibitor experienced severe fatigue, and a pathologic fracture of right humerus occurred by slipping down which was tightly linked with the adverse event of the drug. The pathologic fracture was surgically well managed and the adverse event was well controlled by supportive managements combined with dose reduction of the tyrosine kinase inhibitor. The drug administration to the patient was kept more than 1 year without progression of the disease.

• 한국콘텐츠학회논문지
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• 제9권2호
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• pp.106-114
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• 2009

본 연구에서는 국내 약물부작용감시시스템 연구의 활성화 및 상용화를 목표로 약물부작용 시스템 사례를 분석하고 비즈니스인텔리전스(BI) 기술을 적용하여 약물부작용감시시스템의 기술구조를 제시한다. 최근에는 전자적과정(electronic review)과 수동적 리뷰과정(manual review process)을 병행하는 방법으로 약물부작용을 탐지하는 추세이며, 본 연구에서는 BI 기술중 ETL(Extract, Transform, Loading)을 적용하여 CDW(Clinical DataWarehouse)구축하였다. 부작용 판별 결과 처방의사 701명, 대상 환자는 남자 1,528명, 여자 1,531명으로 기간 내 환자는 총 3059명 이었으며 이중에서 약물부작용으로 의심되는 사례는 전체 318,222건 중에서 약 0.6%에 해당하는 2,085건으로 확인되었다. 이를 신호별로 분류하면 단순유형의 T.Bilirubin> 3mg/dL(부작용 유형-LabR0005)가 전체 2085건에서 548건으로 가장 높았다.

• 한국컴퓨터정보학회논문지
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• 제14권3호
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• pp.183-192
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• 2009

약물부작용감시시스템 (Adverse drug event surveillance system)은 약물부작용신호를 이용하여 약물의 부작용 여부를 식별하는 시스템이다. 기존의 자발적 보고나 차트리뷰 보다 효율성이 뛰어난 시스템으로 분류할 수 있다. 본 논문에서는 약물부작용감시시스템을 구현하기 위하여 임상데이터마트(GDM)를 구축하였다. 특히, 데이터 품질관리 기법을 적용하여 구축된 CDM에 지식 탐사 기법 중 비교사학습 기법으로 적용하여 모델의 재현성을 평가하여 최적의 약물부작용 군집화 개수(n=4)를 도출하였다. 군집화 개수(n=4)를 이용하여 약물부작용 판별을 위한 K-means, Kohonen, two-step clustering model 알고리즘에 적용하여 분석함으로써 K-means 알고리즘이 가장 우수한 군집 효과를 나타냄을 확인하였다.