• Title/Summary/Keyword: adverse drug reactions

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Pharmacogenomics in Drug Discovery and Development

  • Ahn, Chul
    • Genomics & Informatics
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    • v.5 no.2
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    • pp.41-45
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    • 2007
  • Pharmacogenomics is the study that examines how genetic variations affect the ways in which people respond to drugs. The ways people respond to drugs are complex traits that are influenced by many different genes. Pharmacogenomics intends to develop rational means of optimizing drug therapy, with respect to the patients' genotype, to maximize efficacy with minimal adverse drug reactions. Pharmacogenomics has the potential to revolutionize the practice of medicine, and promises to usher in an area of personalized medicine, in which drugs and drug combinations are optimized for each individual's unique genetic makeup. Indeed, pharmacogenomics is exploited as an essential step for target discovery and drug development in the pharmaceutical industry. The goal of the personalized medicine is to get the right dose of the right drug to the right patient at the right time. In this article, we will review the use of pharmacogenomics in drug discovery and development.

Therapeutic Drug Monitoring (TDM) of Psychotropic Drugs (향정신성약물의 치료적 약물농도 검사)

  • Yang, Byung-Hwan
    • Korean Journal of Biological Psychiatry
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    • v.5 no.1
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    • pp.56-65
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    • 1998
  • Clinicians can use therapeutic drug monitoring(TDM) to optimise dosage decisions with psychotropic drugs, in order to maximize efficacy and prevent toxicity, especially when individuals are nonresponsive to treatment or vulnerable to adverse reactions with standard doses because age, disease states or drug interactions. Currently, therapeutic drug concentrations have been established for the TCA and lithium. There is also evidence for the usefulness of TDM with carbamazepine, valproic acid and some antipsychotic drugs. However for most psychotropic drugs this approach remains experimental. TDM-assisted psychiatric treatment is potentially useful and cost effective, particularly when applied by psychiatrists who are knowledgeable of pharmacokinetics and pharmacodynamics.

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Three Adverse Events Reports of Simple Exanthematous Eruption after Sumsu (Bufonis Venenum) Pharmacopuncture Topical Treatment (섬수약침 국소시술 이후 발생한 단순 피부 발진: 3 이상사례 보고)

  • Yoon, Sang-Hoon;Jo, Hee-Geun;Song, Min-Yeong;Seo, Hyung-Sik
    • Journal of Korean Medicine Rehabilitation
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    • v.28 no.3
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    • pp.119-124
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    • 2018
  • Three cases of simple exanthematous eruption were suspected during Sumsu (Bufonis Venenum) pharmacopuncture (SP) topical anesthesia for acupotomy. Patients had skin rash with pruritus on both ankle, posterior neck, and left shoulder after 11, 12, and 7 times of SP treatment, respectively. There were no cases of systemic manifestations or changes in vital signs. As a result of using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) causality assessment, all the cases were evaluated as 'unlikely'. However, the results of using the Korean algorithm for assessing the causality of drug adverse reactions version 2.0 were evaluated as 'possible'. This report is the first case report on adverse events suspected of occurring after SP treatment. Although the causal relationship between suspected intervention and the adverse event is not clear, there was a difficulty in completely excluding the possibility. Additional safety studies will be required to make SP more widely available.

A Study of Adverse Events that Occurred after Taking Herbal Medicine - Focused on Children and Adolescents (한약 복용 후 발생한 유해사례에 대한 연구 - 소아·청소년을 중심으로)

  • Lee, Ji Hong;Yu, Sun Ae;Lee, Seung Yeon
    • The Journal of Pediatrics of Korean Medicine
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    • v.28 no.3
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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.

Drug Augmentation Strategies in the Treatment of Mood Disdorder (기분장애의 치료에 있어서 약물의 Augmentation Strategies)

  • Chung, Young In
    • Korean Journal of Biological Psychiatry
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    • v.5 no.2
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    • pp.155-161
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    • 1998
  • Mood disorder is a medical illness resulting from the disorder of CNS neurotransmission and its principal therapeutic tool is pharmacotherapy. Psychotherapeutic drugs for mood disorder have some clinical limitations which are due to no or partial response, decreased compliance for drug by the side effects, and delayed therapeutic effects. So, general hope of all clinicians that mood diorder will respond to a single psychotherapeutic agent may be the exception rather than the rule. Recently, combined drug treatments have become increasingly popular to overcome the clinical limitations of individual agent in mood disorder. Combined treatments are usually used for augmenting or initiating rapidly the effect of drug, and for treating different target symptoms or drug side effects. When combined treatments being tried, knowledge of the action mechanism, pharmacokinetics, and pharmacodynamics is crucial to cope with the possible adverse reactions of drugs.

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Consideration of adverse effects of herbal drug: focussing on hepatic damage (한약물의 유해반응에 대한 고찰: 간손상을 중심으로)

  • Jung, Jong-Mi;Son, Chang-Gue
    • Journal of Haehwa Medicine
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    • v.17 no.1
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    • pp.53-57
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    • 2008
  • These day, herbal drugs have been widely used in all over the world, as primary therapeutics or supplements for treating various diseases. Herbal drugs are generally regarded as non-toxic due to their natural origin and long history traditionally used without serious adverse reactions. However, plenty warnings have been reported, particularly about the potential hepatotoxicity of herbal products. This report would be helpful for understanding theory of toxicology and prevent from herbal drug-derived hepatotoxicity in Oriental medicinal field.

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Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Associated with Acetaminophen Use during Viral Infections

  • Ga-Young Ban;Seun-Joo Ahn;Hye-Soo Yoo;Hae-Sim Park;Young-Min Ye
    • IMMUNE NETWORK
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    • v.16 no.4
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    • pp.256-260
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    • 2016
  • An association between drug treatment for viral infections and severe cutaneous adverse reactions has been noted. We investigated six patients diagnosed with Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) after being prescribed acetaminophen for suspected viral illnesses. Multiplex analysis was performed to measure cytokine levels in sera before and after treatment. IL-2Ra levels significantly decreased during the convalescence phase. Although acetaminophen is relatively safe, the drug can trigger SJS/TEN in patients with suspected viral infections. T-cells and monocytes may be key components of the link between viral infection and acetaminophen-induced SJS/TEN.

Study for Association between Adverse Drug Reactions and Causative Drugs in the Elderly Using Data-mining Analysis (데이터마이닝 분석을 이용한 노인약물유해반응과 원인약물의 연관성연구)

  • Lee, Mee Woo;Lee, Jeong Seon;Han, Ok Yeon;Choi, In Young;Jeong, Seung Hee;Yim, Hyeon Woo;Lee, Dong Gun;La, Hyen O;Park, Young Min
    • Korean Journal of Clinical Pharmacy
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    • v.24 no.1
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    • pp.39-44
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    • 2014
  • Purpose: To investigate adverse drug reactions (ADR) and causative drugs in the elderly 65 years of age or older, using Korean spontaneous reporting adverse events reporting database from June 2009 to December 2010. Methods: We estimated the association between ADRs and implicated medications by calculating a proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). We reexamined the most frequently implicated medications and ADRs, and the seriousness of ADRs. Then, we assessed reports and concordant rate of ADRs due to medications designated as "high-risk" in elderly by 2012 healthcare effectiveness data and information set (HEDIS) or "potentially inappropriate" by 2012 American Geriatrics Society updated Beers criteria for potentially inappropriate medications (PIMs). Results: Among 15,484 elderly reports, data-mining analysis by PRR, ROR and IC showed that 421 drug-ADR pairs were detected as signals (3,189). The most frequently reported ADR and causative drug were urticaria (470) and contrast media agents (647), respectively. One hundred eighty nine ADR cases were graded as serious. Twenty-two kinds of high-risk medications were shown to be implicated in only 0.9% of ADRs. Only thirty-nine cases were consistent with 2012 Beers criteria or HEDIS. Conclusion: These results suggest that management of the other medications including contrast media agents as well as close monitoring of PIMs are necessary for reducing ADRs in the elderly.

Analysis of L-asparaginase Related Adverse Reaction (L-asparaginase 약물 유해 반응 보고 분석)

  • Ko, Kyung Mi;La, Hyen O
    • 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.

A Review on the Cause of Fever During Clozapine Treatment (클로자핀 투약시 나타나는 발열의 원인)

  • Jihye, Song;Sungsuk, Je;Jaejong, Lee;Seungyun, Lee;Seung-Hoon, Lee;Eunyoung, Lee;Hyungseok, So;Hayun, Choi;Jinhee, Choi
    • Korean Journal of Psychosomatic Medicine
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    • v.30 no.2
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    • pp.66-72
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    • 2022
  • Clozapine is accepted as the "gold standard" antipsychotics for treatment-resistant schizophrenia. Clozapine rarely causes extrapyramidal syndrome and tardive dyskinesia, which are common with other antipsychotics, and only a transient elevation of hyperprolactinemia has been reported. Despite such clinical usefulness, there are limitations to the use of clozapine due to adverse drug reactions (ADR). Fever is a common in adverse drug reactions associated with clozapine. At initiation of clozapine most fatal ADR such as agranulocytosis and neuroleptic malignant syndrome associated with fever, in which case clozapine should be discontinued immediately. However, as benign causes of fever are much more frequent than life-threatening ADR, clozapine should not be discontinued unconditionally in the event of fever during clozapine initiation. In addition, fever may occur at any time during the maintenance of clozapine treatment. In particular, since the risk of pneumonia does not decrease over time, and clozapine has a higher risk of pneumonia than other antipsychotic drugs, it is recommended to adjust clozapine dosage through therapeutic drug monitoring.