Database : MEDLINE
Search on : Agranulocytosis [Words]
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[PMID]: 29522579
[Au] Autor:Mercurio E; Rodante D
[Ad] Address:Capítulo de Discapacidad Intelectual y del Desarrollo de APSA. ezequielmercurio@gmail.com.
[Ti] Title:Propuesta de consentimiento informado por representación para el tratamiento con clozapina. [Proposal of informed consent by representation for treatment with clozapine].
[So] Source:Vertex;XXVIII(135):330-337, 2017 Sep.
[Is] ISSN:0327-6139
[Cp] Country of publication:Argentina
[La] Language:spa
[Ab] Abstract:Clozapine-induced agranulocytosis, a potentially serious adverse effect, is a limiting factor for its therapeutic use, leading to the suspension of the drug. Its annual incidence in Argentina is 0.05%. In 2000, under provision number 935, the ANMAT approved the Monitoring Program for Ambulatory and Inpatient Patients Treated with Clozapine. In this provision arises the obligation to sign the informed consent where the patient is informed of the risks and benefts of the treatment. In psychiatric care practice patients may not possess, because of their altered psychic state, the level of competence necessary to sign informed consent for their treatment with clozapine. The objective of the present work is to analyze the doctrine of Informed Consent by Representation for the users of clozapine, as well as to propose a decision algorithm for its application in clinical practice.
[Pt] Publication type:ENGLISH ABSTRACT; JOURNAL ARTICLE
[Em] Entry month:1803
[Cu] Class update date: 180309
[Lr] Last revision date:180309
[St] Status:In-Data-Review

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[PMID]: 29519170
[Au] Autor:Behera SK; Das S; Xavier AS; Selvarajan S
[Ad] Address:a Department of Clinical Pharmacology , Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) , Puducherry , India.
[Ti] Title:DRESS syndrome: a detailed insight.
[So] Source:Hosp Pract (1995);, 2018 Mar 08.
[Is] ISSN:2154-8331
[Cp] Country of publication:England
[La] Language:eng
[Ab] Abstract:Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome is a serious and potentially fatal adverse effect to therapeutic medications. The incidence of this condition varies among different ethnicities because of the difference in the genetic makeup. Though fever, rash and eosinophilia are essential features for the diagnosis of this syndrome, these vary from patient to patient along with the involvement of various organs such as liver, kidney, lungs, pancreas, etc. Some of the atypical features are dysphagia, agranulocytosis, and chylous ascites. Phenytoin, phenobarbitone, carbamazepine, and allopurinol are the most common drugs responsible for developing this syndrome, although the list is fairly long. Among the criteria used for the diagnosis of DRESS syndrome, European Registry of Severe Cutaneous Adverse Reactions to Drugs and Collection of Biological Samples (RegiSCAR) criteria is the most commonly used one. The management of this syndrome involves early removal of the causative agent and treatment with anti-histamines and emollients in the mild form, corticosteroids in the moderate form and plasmapheresis in the severe form along with other alternatives drugs. Healthcare professionals should be more vigilant about the early manifestations of this syndrome, as early diagnosis and treatment improve outcomes considerably.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1803
[Cu] Class update date: 180309
[Lr] Last revision date:180309
[St] Status:Publisher
[do] DOI:10.1080/21548331.2018.1451205

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[PMID]: 29517519
[Au] Autor:Li KJ; Greenstein AP; Delisi LE
[Ad] Address:VA Boston Healthcare System.
[Ti] Title:Sudden death in schizophrenia.
[So] Source:Curr Opin Psychiatry;, 2018 Mar 06.
[Is] ISSN:1473-6578
[Cp] Country of publication:United States
[La] Language:eng
[Ab] Abstract:PURPOSE OF REVIEW: To examine the recent literature regarding sudden death in patients with schizophrenia and synthesize salient conclusions based on this evidence. RECENT FINDINGS: Sudden cardiac death (SCD) is the largest subset of sudden unexpected death (SUD), with up to 40% of SUD from cardiovascular causes. SCD has been associated with exposure to both first and second-generation antipsychotics. Clozapine [odds ratio (OR) 3.67, 95% confidence interval (CI) 1.94-6.94] confers the highest risk of SCD followed by risperidone (OR 3.04, 95% CI 2.39-3.86) then olanzapine (OR 2.04, 95% CI 1.52-2.74). SCD not associated with antipsychotic use has been correlated to several modifiable and nonmodifiable risk factors - obesity, smoking, dyslipidemia, diabetes, hypertension, age, sex, and history of cardiovascular disease. Other subsets of SUD include hematological and pulmonary causes, including agranulocytosis leading to sepsis, deep vein thrombosis leading to pulmonary embolisms, and aspiration pneumonia leading to sepsis. SUMMARY: There is a huge paucity in genetic and pharmacogenetic data focused on SUD in schizophrenia. Future studies should emphasize the genetic aspects as well as clarify the underlying molecular mechanisms of these pathways. Additionally, early detection of those patients at high risk for SUD and discovery of preventive measures should also be emphasized.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1803
[Cu] Class update date: 180308
[Lr] Last revision date:180308
[St] Status:Publisher
[do] DOI:10.1097/YCO.0000000000000403

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[PMID]: 28742291
[Au] Autor:Sultan RS; Olfson M; Correll CU; Duncan EJ
[Ad] Address:New York State Psychiatric Institute/Department of Psychiatry, College of Physicians and Surgeons of Columbia University, 1051 Riverside Dr, New York, NY 10032. rs3511@cumc.columbia.edu.
[Ti] Title:Evaluating the Effect of the Changes in FDA Guidelines for Clozapine Monitoring.
[So] Source:J Clin Psychiatry;78(8):e933-e939, 2017 Sep/Oct.
[Is] ISSN:1555-2101
[Cp] Country of publication:United States
[La] Language:eng
[Ab] Abstract:BACKGROUND: Concerns exist that clozapine is underutilized in the management of treatment-resistant schizophrenia. Although a 2015 change in the US Food and Drug Administration (FDA) monitoring recommendations lowered the threshold of the absolute neutrophil count for treatment interruption from 1,500/µL to 1,000/µL and removed white blood cell count thresholds from the monitoring algorithm, the implications of this policy change on clozapine interruptions remain unknown. METHODS: We analyzed outpatient prescribing records for antipsychotic medications in the Veterans Integrated Service Network 7 (VISN 7) database between 1999 and 2012 to assess the potential impact of the recent changes in FDA neutropenia monitoring recommendations on clozapine treatment discontinuation. We evaluated results of complete blood count monitoring to compare percentages of patients who developed or would have developed ≥ 1 hematologic event under the previous and current FDA guidelines in the first year following initiation of clozapine. RESULTS: From a cohort of 14,620 patients with schizophrenia (ICD-9-295.x), 246 patients received clozapine treatment (1.7%). No agranulocytosis was observed during the study period. Under the former recommendations, 5 patients in the clozapine initiation cohort (n = 160, 3.1%; 95% CI, 0.43-5.83) qualified for treatment interruption during the first year of clozapine treatment, while only 1 patient (0.6%) qualified under the current recommendations. Under the former recommendations, hematologic events occurred at a similar rate for individuals taking and not taking clozapine. CONCLUSIONS: While clozapine remains an underused medication, the new FDA monitoring guidelines are likely to substantially reduce the percentage of patients who meet criteria for clozapine-associated hematologic events requiring treatment interruption. This decrease may reduce the clinical burden of managing patients on clozapine and therefore increase the number of individuals treated with this uniquely effective medication. However, prospective studies of individuals treated under the new guidelines are needed to fully assess safety of the FDA's change.
[Mh] MeSH terms primary: Clozapine
Drug Monitoring
Neutropenia
Schizophrenia/drug therapy
[Mh] MeSH terms secundary: Adult
Adverse Drug Reaction Reporting Systems/statistics & numerical data
Antipsychotic Agents/administration & dosage
Antipsychotic Agents/adverse effects
Clozapine/administration & dosage
Clozapine/adverse effects
Drug Monitoring/methods
Drug Monitoring/statistics & numerical data
Drug Prescriptions/statistics & numerical data
Female
Humans
Leukocyte Count
Male
Medication Therapy Management/organization & administration
Medication Therapy Management/standards
Middle Aged
Neutropenia/chemically induced
Neutropenia/diagnosis
Neutropenia/epidemiology
Neutropenia/prevention & control
Pharmacovigilance
Practice Guidelines as Topic
Psychiatric Status Rating Scales
Quality Improvement
Schizophrenia/diagnosis
Schizophrenia/epidemiology
United States/epidemiology
United States Food and Drug Administration
[Pt] Publication type:JOURNAL ARTICLE
[Nm] Name of substance:0 (Antipsychotic Agents); J60AR2IKIC (Clozapine)
[Em] Entry month:1711
[Cu] Class update date: 180308
[Lr] Last revision date:180308
[Js] Journal subset:IM
[Da] Date of entry for processing:170726
[St] Status:MEDLINE

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[PMID]: 29505490
[Au] Autor:Manu P; Lapitskaya Y; Shaikh A; Nielsen J
[Ad] Address:Hofstra Northwell School of Medicine, Hempstead, NY.
[Ti] Title:Clozapine Rechallenge After Major Adverse Effects: Clinical Guidelines Based on 259 Cases.
[So] Source:Am J Ther;25(2):e218-e223, 2018 Mar/Apr.
[Is] ISSN:1536-3686
[Cp] Country of publication:United States
[La] Language:eng
[Ab] Abstract:BACKGROUND: Clozapine is widely prescribed for treatment-refractory schizophrenia, but its use is limited by many potentially life-threatening adverse effects. The risk of rechallenge after these complications has never been comprehensively assessed in controlled studies. Thus, clinical guidelines must rely on the published case reports. The number of such reports is likely to increase over time, and updated analyses of larger samples are needed, as they may lead to changes in clinical guidelines. STUDY QUESTIONS: How safe is the clozapine rechallenge after life-threatening adverse effects? STUDY DESIGN: The published case reports of clozapine rechallenge were identified in a MEDLINE search. We added 121 cases reported from 2012 through 2017 to the 138 cases reported from 1972 through 2011 analyzed by us in a previous publication. The 95% confidence intervals (CIs) of the successful rechallenge rate were calculated for each adverse effect with at least 5 published case reports. The rechallenge was considered a valid clinical option when the lower end of the CI range was at least 50%. RESULTS: A successful outcome was documented in 128/203 patients rechallenged after neutropenia (63.0%, CI, 56.0%-69.6%), 3/17 after agranulocytosis (17.7%, CI, 4.7%-44.2%), 11/17 after myocarditis (64.7%, CI, 38.6%-84.7%), and 7/7 after neuroleptic malignant syndrome (100%, CI, 56.1%-100%). Among the 15 patients with other clozapine-induced adverse effects, the rechallenge was successful in those with eosinophilia, cardiac complications other than myocarditis (QTc prolongation, pericarditis, cardiomyopathy, and atrial flutter), and gastrointestinal hypomotility. The rechallenge failed in patients who had developed pancreatitis or renal insufficiency. CONCLUSION: Clozapine rechallenge is a reasonable clinical option after return to baseline for patients who had developed neutropenia and neuroleptic malignant syndrome, but not after agranulocytosis or myocarditis. Data are insufficient to formulate rechallenge guidelines for any other clozapine-related adverse effects.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1803
[Cu] Class update date: 180305
[Lr] Last revision date:180305
[St] Status:In-Process
[do] DOI:10.1097/MJT.0000000000000715

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[PMID]: 29503232
[Au] Autor:Li KJ; Gurrera RJ; Delisi LE
[Ad] Address:VA Boston Healthcare System, 940 Belmont St., Bld 2, Brockton, MA 02301, USA; Harvard South Shore Psychiatry Residency Training Program, 940 Belmont St., Bld 5 116-A7, Brockton, MA, 02301, USA; Harvard Medical School, 25 Shattuck St., Boston, MA 02115, USA. Electronic address: kevin.li2@va.gov.
[Ti] Title:Potentially fatal outcomes associated with clozapine.
[So] Source:Schizophr Res;, 2018 Mar 01.
[Is] ISSN:1573-2509
[Cp] Country of publication:Netherlands
[La] Language:eng
[Ab] Abstract:Clozapine has been shown to be the most efficacious therapy for treatment resistant schizophrenia, estimated at one third of all schizophrenia cases. There is significant morbidity and mortality associated with clozapine including risk of agranulocytosis, aspiration pneumonia, bowel ischemia, myocarditis, seizures, and weight gain. Here we present a case of a 62-year-old man with chronic paranoid schizophrenia refractory to numerous antipsychotics who was started on clozapine therapy during an acute inpatient psychiatric admission. Within three weeks of starting clozapine, the patient developed flu-like symptoms, pleuritic chest pain, and was sent to a medical hospital for evaluation. After transfer, the patient had a rapidly deteriorating course with newly developed congestive heart failure, acute respiratory failure requiring intubation, and cardiovascular collapse requiring vasopressors. The patient expired within two days of transfer and four days after initial symptoms developed. The underlying etiology in this case is likely clozapine induced myocarditis leading to rapid cardiovascular collapse and death. Mortality with clozapine induced myocarditis has been estimated up to 24%. Given that 90% of clozapine cardiotoxic sequelae are seen in the first month post-initiation, more rigorous post-initiation surveillance is recommended for the first four weeks of clozapine with weekly cardiac enzymes (troponins, creatinine kinase-MB), EKG, and acute inflammatory markers (C-reactive protein, and erythrocyte sedimentation rate).
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1803
[Cu] Class update date: 180305
[Lr] Last revision date:180305
[St] Status:Publisher

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[PMID]: 29270983
[Au] Autor:Hoenig M; Pannicke U; Gaspar HB; Schwarz K
[Ad] Address:Department of Paediatrics, University Medical Centre Ulm, Ulm, Germany.
[Ti] Title:Recent advances in understanding the pathogenesis and management of reticular dysgenesis.
[So] Source:Br J Haematol;180(5):644-653, 2018 Mar.
[Is] ISSN:1365-2141
[Cp] Country of publication:England
[La] Language:eng
[Ab] Abstract:Reticular Dysgenesis is a rare immunodeficiency which is clinically characterized by the combination of Severe Combined Immunodeficiency (SCID) with agranulocytosis and sensorineural deafness. Mutations in the gene encoding adenylate kinase 2 (AK2) were identified to cause this phenotype. In this review, we will demonstrate important clinical differences between reticular dysgenesis and other SCID entities and summarize recent concepts in the understanding of the pathophysiology of the disease and the management strategies for this difficult condition.
[Pt] Publication type:JOURNAL ARTICLE; REVIEW
[Em] Entry month:1712
[Cu] Class update date: 180221
[Lr] Last revision date:180221
[St] Status:In-Data-Review
[do] DOI:10.1111/bjh.15045

  8 / 7596 MEDLINE  
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[PMID]: 29281794
[Au] Autor:den Braver-Sewradj SP; den Braver MW; Toorneman RM; van Leeuwen S; Zhang Y; Dekker SJ; Vermeulen NPE; Commandeur JNM; Vos JC
[Ad] Address:AIMMS-Division of Molecular Toxicology, Department of Chemistry and Pharmaceutical Sciences, Vrije Universiteit , De Boelelaan 1108, 1081 HZ Amsterdam, The Netherlands.
[Ti] Title:Reduction and Scavenging of Chemically Reactive Drug Metabolites by NAD(P)H:Quinone Oxidoreductase 1 and NRH:Quinone Oxidoreductase 2 and Variability in Hepatic Concentrations.
[So] Source:Chem Res Toxicol;31(2):116-126, 2018 Feb 19.
[Is] ISSN:1520-5010
[Cp] Country of publication:United States
[La] Language:eng
[Ab] Abstract:Detoxicating enzymes NAD(P)H:quinone oxidoreductase 1 (NQO1) and NRH:quinone oxidoreductase 2 (NQO2) catalyze the two-electron reduction of quinone-like compounds. The protective role of the polymorphic NQO1 and NQO2 enzymes is especially of interest in the liver as the major site of drug bioactivation to chemically reactive drug metabolites. In the current study, we quantified the concentrations of NQO1 and NQO2 in 20 human liver donors and NQO1 and NQO2 activities with quinone-like drug metabolites. Hepatic NQO1 concentrations ranged from 8 to 213 nM. Using recombinant NQO1, we showed that low nM concentrations of NQO1 are sufficient to reduce synthetic amodiaquine and carbamazepine quinone-like metabolites in vitro. Hepatic NQO2 concentrations ranged from 2 to 31 µM. NQO2 catalyzed the reduction of quinone-like metabolites derived from acetaminophen, clozapine, 4'-hydroxydiclofenac, mefenamic acid, amodiaquine, and carbamazepine. The reduction of the clozapine nitrenium ion supports association studies showing that NQO2 is a genetic risk factor for clozapine-induced agranulocytosis. The 5-hydroxydiclofenac quinone imine, which was previously shown to be reduced by NQO1, was not reduced by NQO2. Tacrine was identified as a potent NQO2 inhibitor and was applied to further confirm the catalytic activity of NQO2 in these assays. While the in vivo relevance of NQO2-catalyzed reduction of quinone-like metabolites remains to be established by identification of the physiologically relevant co-substrates, our results suggest an additional protective role of the NQO2 protein by non-enzymatic scavenging of quinone-like metabolites. Hepatic NQO1 activity in detoxication of quinone-like metabolites becomes especially important when other detoxication pathways are exhausted and NQO1 levels are induced.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1712
[Cu] Class update date: 180219
[Lr] Last revision date:180219
[St] Status:In-Data-Review
[do] DOI:10.1021/acs.chemrestox.7b00289

  9 / 7596 MEDLINE  
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[PMID]: 29432206
[Au] Autor:de Souza EC; Matos DM; Viana MR; Alvim MCO; Bonfante HL; Pinto AF; Nascimento JWL
[Ad] Address:University of Iowa College of Pharmacy, Division of Medicinal and Natural Products Chemistry, Iowa City, IA, USA.
[Ti] Title:Evaluation of hematological alterations after therapeutic use of dipyrone in healthy adults: a prospective study.
[So] Source:J Basic Clin Physiol Pharmacol;, 2018 Feb 13.
[Is] ISSN:2191-0286
[Cp] Country of publication:Germany
[La] Language:eng
[Ab] Abstract:BACKGROUND: Dipyrone is a non-narcotic analgesic/antipyretic widely used in some countries but prohibited in others due to suspected risk of agranulocytosis. The primary goal of this study was to evaluate hematological alterations in healthy adult volunteers after treatment with dipyrone. METHODS: The study enrolled 30 healthy volunteers of both genders, aged 19-37 years. They received tablets containing 500 mg of dipyrone sodium to be used four times daily for 7 consecutive days. Before the first administration, arterial pressure was measured and blood was collected in order to evaluate hematological baseline parameters. On the 8th day after the beginning of treatment, the volunteers had their blood pressure assessed once more and underwent a second blood draw. Total and specific leukocyte counts, creatinine, urea, aspartate aminotransferase (AST), alanine aminotransferase (ALT), erythrocytes, and platelets were quantitatively determined. RESULTS: No statistically significant difference was observed among total or specific leukocyte counts. Number of platelets, erythrocytes, hemoglobin, and hematocrit decreased after treatment. Diastolic pressure, mean arterial pressure (MAP), and urea concentration declined, while creatinine, AST, and ALT showed no significant alterations. It is noteworthy that, even for parameters that showed statistically significant changes, the highest and lowest values remained within the normal ranges. CONCLUSIONS: Although dipyrone has historically been associated with agranulocytosis, leukocyte counts remained practically unchanged after oral administration of dipyrone. On the other hand, the present study adds evidence that dipyrone is able to produce statistically relevant decrease in number of platelets, erythrocytes, hemoglobin, and hematocrit in healthy adults, even after short-term treatment.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1802
[Cu] Class update date: 180213
[Lr] Last revision date:180213
[St] Status:Publisher

  10 / 7596 MEDLINE  
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[PMID]: 29436141
[Au] Autor:de Leeuw TG; Dirckx M; de Wildt SN
[Ad] Address:Department of Anesthesiology, Erasmus MC - Sophia Children's Hospital, Rotterdam, The Netherlands.
[Ti] Title:Reply to Ziesenitz, Victoria; Erb Thomas; Trachsel, Daniel; van den Anker Johannes, regarding their comment "Safety of dipryone (metamizole) in children-what's the risk of agranulocytosis?"
[So] Source:Paediatr Anaesth;28(3):305-306, 2018 Mar.
[Is] ISSN:1460-9592
[Cp] Country of publication:France
[La] Language:eng
[Pt] Publication type:LETTER
[Em] Entry month:1802
[Cu] Class update date: 180213
[Lr] Last revision date:180213
[St] Status:In-Data-Review
[do] DOI:10.1111/pan.13326


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