2020
DOI: 10.9740/mhc.2020.05.070
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Clozapine and hematologic adverse reactions: Impact of the Risk Evaluation and Mitigation Strategy program

Abstract: Introduction In October 2015, the Food and Drug Administration (FDA) instituted an update to the mandatory Risk Evaluation and Mitigation Strategy (REMS) program for clozapine to improve safety monitoring of hematologic events. However, the impact of the clozapine REMS program on reporting of hematologic adverse events has not been quantified. Methods We assessed adverse event reports for agranulocytosis, granulocytopenia, le… Show more

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Cited by 9 publications
(4 citation statements)
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“…Otro hallazgo relevante es el uso de clozapina en 8,7% de pacientes, pues su indicación además de pacientes con esquizofrenia resistentes al manejo convencional (26) , involucra a los pacientes con TB refractario, de allí su uso en este grupo. No obstante, llama la atención que sólo fuese empleada en monoterapia, lo que genera dudas acerca de su indicación en pacientes que no respondieron al tratamiento de primera línea (20) , pero siempre teniendo en consideración que su uso se puede asociar a reacciones adversas severas que incluyen aplasia medular, agranulocitosis, trombocitopenia, y que debería acompañarse también de pruebas de laboratorio para hacer seguimiento y monitoreo de su toxicidad (27) .…”
Section: Discussionunclassified
“…Otro hallazgo relevante es el uso de clozapina en 8,7% de pacientes, pues su indicación además de pacientes con esquizofrenia resistentes al manejo convencional (26) , involucra a los pacientes con TB refractario, de allí su uso en este grupo. No obstante, llama la atención que sólo fuese empleada en monoterapia, lo que genera dudas acerca de su indicación en pacientes que no respondieron al tratamiento de primera línea (20) , pero siempre teniendo en consideración que su uso se puede asociar a reacciones adversas severas que incluyen aplasia medular, agranulocitosis, trombocitopenia, y que debería acompañarse también de pruebas de laboratorio para hacer seguimiento y monitoreo de su toxicidad (27) .…”
Section: Discussionunclassified
“…the Drooling severity scale or Nocturnal Hypersalivation Rating Scale 374,375  Sugar free chewing gum during the day; elevation of upper body during the night 375  Pirenzepine (25-100 mg/d); Cave: anticholinergic load 16, 91,371  Alternative options: atropine drops s.l., ipratropium bromide s.l. 371  Botulinumtoxin injection (incobotulinum toxin A) into the parotid and submandibular glands 16,260,264,373,[376][377][378] Qubad & Bittner -Clozapine treatment in schizophrenia Constipation, CIGH* 385,386  Regular clinical assessment 91,98,146  Physical activity, sufficient fluid intake, fiber-rich diet 16,91,214,215  Discontinue non-essential drugs that increase anticholinergic load 212,213  Treatment with laxatives [214][215][216] Qubad & Bittner -Clozapine treatment in schizophrenia 34 Hematological side effects 148,156  Complete differential blood count: at baseline, once weekly (1 st -18 th week), then monthly; in case of discontinuation continue monitoring for four weeks 72,91,387  Leukopenia (white blood cells (WBC) < 4/nl) vs. CIN (ANC < 1,5/nl) vs. CIA (ANC < 0,5/nl) 72, [387][388][389] o In Cases of WBC 3-3,5/nl and ANC 1,5-2/nl:…”
Section: Cyp Inducers Cyp Inhibitorsmentioning
confidence: 99%
“…the Drooling severity scale or Nocturnal Hypersalivation Rating Scale 374,375  Sugar free chewing gum during the day; elevation of upper body during the night 375  Pirenzepine (25-100 mg/d); Cave: anticholinergic load 16, 91,371  Alternative options: atropine drops s.l., ipratropium bromide s.l. 371  Botulinumtoxin injection (incobotulinum toxin A) into the parotid and submandibular glands 16,260,264,373,[376][377][378] Qubad & Bittner -Clozapine treatment in schizophrenia Constipation, CIGH* 385,386  Regular clinical assessment 91,98,146  Physical activity, sufficient fluid intake, fiber-rich diet 16,91,214,215  Discontinue non-essential drugs that increase anticholinergic load 212,213  Treatment with laxatives [214][215][216] Qubad & Bittner -Clozapine treatment in schizophrenia 34 Hematological side effects 148,156  Complete differential blood count: at baseline, once weekly (1 st -18 th week), then monthly; in case of discontinuation continue monitoring for four weeks 72,91,387  Leukopenia (white blood cells (WBC) < 4/nl) vs. CIN (ANC < 1,5/nl) vs. CIA (ANC < 0,5/nl) 72, [387][388][389] o In Cases of WBC 3-3,5/nl and ANC 1,5-2/nl:…”
Section: Cyp Inducers Cyp Inhibitorsmentioning
confidence: 99%