• Korean Journal of Clinical Pharmacy
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• v.20 no.2
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• pp.151-158
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• 2010

Therapeutic drug monitoring of Mycophenolate mofetil(MMF) has been suggested in some clinical trials, but has not been widely adopted in Korea. The purpose of this study was to analyze the withdrawal rates of MMF and determine the characteristics of the patients who experienced adverse reactions with MMF therapy and to suggest the criteria for selecting patients who need monitoring of MMF levels. We retrospectively collected data of patients who started MMF between July 2007 and June 2008. A total of 154 adult patients were included in our study. Among them, ninety seven patients discontinued MMF with 59 cases being due to adverse drug reactions. Thirty one patients required dosage reduction of MMF with twenty three cases being due to adverse reactions. Twenty six patients continued the MMF without or with mild adverse reactions. Of the 82 adverse reaction cases, hematologic adverse reactions accounted for 38 cases (46%) and gastrointestinal (GI) adverse reactions accounted for 28 cases (34%). Older age and lower serum albumin levels were significantly different characteristics between the patients who withdraw MMF due to hematological adverse reactions and those who were able to continue therapy. The group who experienced GI adverse reactions had higher MMF dosages based on body weight and lower serum albumin levels. In conclusion, the factors affecting the adverse reactions of MMF were age, serum albumin level and higher dosage, therefore therapeutic drug monitoring of MMF should be considered in these patients.

• Proceedings of the PSK Conference
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• 2002.10a
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• pp.432-432
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• 2002

Drug used in hospital is allowed marketing through after pharmacological and toxicological tests using various animals and clinical test of human in developing state. But as pre-marketing clinical study take short period with relatively a few of patients and strict selection criteria of people, pediatric, geriatric. pregnancy, liver and kidney patients may be excluded. As the safety of drug isn't completely evaluated before launching. it is important to collect and evaluate drug adverse reaction newly reported by medical practitioners and pharmacists. (omitted)

• Journal of Korean Academy of Nursing Administration
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• v.22 no.1
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• pp.91-98
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• 2016

Purpose: The aim of this study was to identify the relationship between nurses' knowledge of adverse drug reactions (ADR), attitudes, and monitoring practices and to establish an effective ADR reporting system and provide baseline data for its activation. Methods: The participants in this study were chosen by convenience sampling and included 182 nurses working at major general hospitals that operate a Regional Drug Safety Center. Data were collected from June 1 to 12, 2015 and analyzed using Cronbach's ${\alpha}$, descriptive statistics, independent t-test, one way ANOVA, Pearson correlation coefficient and stepwise regression with the SPSS program. Results: The nurses' average score for knowledge was 7.62 points, for attitude, 41.04 points and for monitoring practices, 34.22 points. ADR monitoring practices positively correlated with knowledge (r=.19, p=.011), attitude (r=.41, p<.001), drug performance competency (r=.54, p<.001), and drug education satisfaction (r=.54, p<.001). Drug performance competency, drug education satisfaction, and attitudes explained 42.0% of the ADR monitoring practices (Adj $R^2=.42$, F=43.95, p<.001). Conclusion: In order to facilitate and encourage nurses' voluntary monitoring practice of ADR, efforts must be made to create positive attitudes toward ADR, and to increase drug performance competency and drug education satisfaction.

• The Journal of Internal Korean Medicine
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• v.35 no.2
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• pp.111-118
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• 2014

Drugs may cause adverse effects, and spontaneous adverse drug reaction (ADR) reports have been used as the main method of drug safety evaluation after drugs have been released. The World Health Organization (WHO) collects ADR data reported from pharmacovigilance organizations in each nations. In China, pharmacovigilance centers operate with hierarchical structure at local, provincial and national levels. Also, Japan and Korea each operate their own respective independent pharmacovigilance organizations. WHO is collecting ADR reports for herbal medicine and 15~20% of all ADRs was related to herbal medicine in China. There are status reports of ADRs for herbal medicine in Japan as well. However, in Korea, there is no ADR reporting system regarding herbal medicine. In light of these overseas cases, a spontaneous ADR reporting system for herbal medicine in Korea should be necessary as well.

• Korean Journal of Clinical Pharmacy
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• v.27 no.3
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• pp.143-149
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• 2017

Background: L-asparaginase (L-ASP) is a critical agent for the treatment of acute lymphoblastic leukemia and lymphoma, which is associated with serious toxicities including hypersensitivity, pancreatitis and thrombosis. Methods: To evaluate the toxicity of L-ASP in real clinical settings, we included the patients with L-ASP adverse drug reactions (ADRs) reported in a regional pharmacovigilance center of Seoul St. Mary's hospital from January 2014 to December 2015. Results: A total of 83 cases of L-ASP related ADRs were reported in 54 patients. Of these 83 cases, 65 cases (78.3%, 65/83) were spontaneously reported and 18 cases (21.7%, 18/83) were detected by further medical records review. Of the patients with ADRs, pediatric patients accounted for 83.3% of the cases (45/54) and median age was 9 years. The most common clinical manifestations of ADRs were hematology manifestations (31.3%, 26/83), followed by hepatobiliary manifestations (18.1%, 15/83). Thirty-four serious ADRs were reported in 19 patients. The sserious ADR group showed significantly longer hospitalization and higher rate of discontinuation of L-ASP than the non-serious ADR group (p = 0.005, 0.03). The most common clinical manifestations of serious ADRs were hepatobiliary manifestations (41.2%, 14/34). In total, 8 cases (9.6%, 8/83) of unlabeled ADRs were identified. They were serious ADRs. Conclusion: We identified unlabeled serious ADRs of L-ASP. Also, correlations were observed between serious ADRs and length of hospitalization, discontinuation rate respectively. Further investigations and developed spontaneous ADR reporting systems are needed to evaluate these correlations.

• The Journal of Internal Korean Medicine
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• v.33 no.4
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• pp.485-497
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• 2012

Objectives : The aim of this study was to systematically investigate herbal-drug-associated adverse drug reactions (herbal ADRs) reports submitted by a single oriental hospital and to analyze the general characteristics, causative agents, clinical manifestations, severity and types of herbal medicines which caused herbal ADRs. Methods : This study proceeded with IRB approval. The data on herbal ADR were collected prospectively from January 2008 to February 2012 by EMR of Dongguk University Ilsan Oriental Hospital. The World Health Organization (WHO)-Uppsala Monitoring Center (UMC) criteria was used to determinate causality for each herbal ADR. WHO-Adverse Reaction Terminology (WHO-ART) System Organ Class (SOC) code and WHO severity category were also used in this study. Results : A total of twenty eight cases were reported. Twenty two cases were assessed to have over possible relations with herbal medication. The gender ratio of these cases were 64.6 percent female and 36.4 percent male, demonstrating no statistical significance. Patients aged over 60 were 59.1%. Gastro-intestinal system was reported to be the most frequently affected organ (38.8%), and followed by psychiatric system (22.4%), and integumentary system (22.4%). The most common clinical symptom was headache (12.2%), followed by diarrhea (10.2%), and pruritus (10.2%). The severity of most cases was assessed to be mild (89.8%). The percentage of moderate ones was 10.2%, and there were no severe cases. Conclusions : Progressive study and further analysis on herbal ADRs are warranted for safety in the clinical use of herbal medicines.

• Clinical and Experimental Pediatrics
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• v.57 no.3
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• pp.153-156
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• 2014

Toxic epidermal necrolysis is an unpredictable and severe adverse drug reaction. In toxic epidermal necrolysis, epidermal damage appears to result from keratinocyte apoptosis. This condition is triggered by many factors, principally drugs such as antiepileptic medications, antibiotics (particularly sulfonamide), nonsteroidal anti-inflammatory drugs, allopurinol, and nevirapine. Lamotrigine has been reported potentially cause serious cutaneous reactions, and concomitant use of valproic acid with lamotrigine significantly increases this risk. We describe a case of an 11-year-old girl with tic and major depressive disorders who developed toxic epidermal necrolysis after treatment with lamotrigine, and who was diagnosed both clinically and pathologically. Children are more susceptible to lamotrigine-induced rash than adults, and risk of serious rash can be lessened by strict adherence to dosing guidelines. Unfortunately, in our case, the patient was administered a higher dose than the required regimen. Therefore, clinicians should strictly adhere to the dose regimen when using lamotrigine, especially in children.

• Journal of Veterinary Science
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• v.24 no.6
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• pp.77.1-77.7
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• 2023

Antibiotics are known to be able to cause hypersensitivity reactions through various mechanisms. We present a case of drug-induced immune thrombocytopenia (DITP) and anaphylactic shock occurring simultaneously in a dog after the administration of two classes of antibiotics, namely trimethoprim-sulfamethoxazole (TMP-SMX) and amoxicillin-clavulanate (AMC). The patient recovered completely from DITP on discontinuation of TMP-SMX and the anaphylactic shock caused by AMC was treated with intensive care. DITP is a rare adverse drug reaction (ADR), and anaphylactic shock is a life-threatening ADR. This is the first case report of a dog manifesting two types of hypersensitivity reactions caused by two antibiotics.

• The Korean Journal of Pain
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• v.24 no.4
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• pp.221-225
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• 2011

Hyaluronidase is an enzyme that has temporary and reversible enzymatic effects on the matrix of connective tissue. When added to local anesthetics in pain treatments, it enhances their infiltration and dispersal into tissues. It is widely used in anesthesia for ocular, dental, and plastic surgery. Reports of drug hypersensitivity to hyaluronidase are rare and are usually confined to peribulbar or retrobulbar anesthesia during ophthalmic surgery. However, few reports exist on adverse drug reaction after epidural injection. We have observed two patients experiencing anaphylactic shock caused by hyaluronidase following epidural injection. Most of the patients with a hypersensitivity to hyaluronidase had one previous uneventful injection containing hyaluronidase, implying that sensitization had taken place. However, hypersensitivity occurring at the first administration is possible. A positive skin test can help establish the diagnosis. Although rare, the possibility of an allergic reaction to hyaluronidase should be considered even in patients with no known previous exposure.

• The Journal of the Korea Contents Association
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• v.16 no.9
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• pp.473-481
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• 2016

Adverse drug reactions(ADRs) were caused by dexran 40 in patient with ischemic stroke and related 22 patients reported to formal ADRs at Jesus Hospital in Jeonju. This study was aimed to search ADRs related factors, type and the degree associated with dextran 40. Adverse Effects of Dextran 40 is including marked hypotension, nausea, dyspnea, generalized urticaria, fever and pulmonary edema. The average hospitalization period was 20 days and it was extended 26.8%. ADRs of Dextran 40 to incidence is 12.4%, and 9 persons(28.1%), itching, rash was 7 people (21.9%). Dextran induced ADRs reaction may be reported on early injection period and first time shot, but adverse drug reactions occurred after 4 days in 4 patients(18.2%). US FDA has recommanded that Dextran 1 significantly reduces the incidence of severe ADRs in USA. Because low molecular weighted dextran 1 prevented dextran molecules from combined Ig G completely. In Korea. Generally not yet introduced dextran 1, active use dextran 1 is able to be a good way in order to reduce ADRs of dextran 40.