adverse drug reaction

saedzyoud's picture

Adverse Drug Events in Hospitalized Patients with Acetaminophen Overdose Treated with Intravenous N-Acetylcysteine

Journal Title, Volume, Page: 
Drug Saf 2011; 34 (10): 943
Year of Publication: 
2011
Authors: 
Sa'ed H Zyoud
WHO Collaborating Centre for Drug Information, National Poison Centre, Universiti Sains Malaysia (USM), Penang, Malaysia;College of Pharmacy, An-Najah National University, Nablus, Palestine
Current Affiliation: 
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Rahmat Awang
WHO Collaborating Centre for Drug Information, National Poison Centre, Universiti Sains Malaysia (USM), Penang, Malaysia
Syed Azhar Syed Sulaiman
Clinical Pharmacy Program, School of Pharmaceutical Science, Universiti Sains Malaysia (USM), Penang, Malaysia
Preferred Abstract (Original): 

Background and objectives: Intravenous N-acetylcysteine (IV-NAC) is widely recognized as the antidote of choice for acetaminophen overdose [1]. However, its use is not without adverse drug reactions (ADR) which might affect therapeutic outcome or lead to treatment delay [2, 3]. The aims of this study were to investigate the type and incidence of ADR induced by IV-NAC in patients treated for acetaminophen overdose and to assess the causality of individual ADR to IV-NACusing Naranjo's algorithm [4].
Methods: This is a retrospective study of patients admitted to the hospital for acute acetaminophen overdose over a period of 5 years (January 1, 2004 to December 31, 2008). The primary outcome of interest in this study was the occurrence of ADR during NAC administration. The probability of an ADR was assessed using the Naranjo algorithm, which consists of 10 questions), and has been used to determine the likelihood that an ADR was related to a specific medication [4].
Results: During the study period, 305 patients with a diagnosis of overdose of paracetamol-containing compounds were admitted to the hospital for monitoring and treatment. Different types of ADR occurred in 137 patients (137/305; 44.9%). Of those patients who had an ADR, 98 (98/137; 71.5%) had been treated with IV-NAC and 39 (39/137; 28.5%) had not(p < 0.001). Comparison of different ADR in all patients showed that the following ADR were significantly associated with IV-NAC administration: nausea (p = 0.004), vomiting (p < 0.001), flushing (p < 0.001), rash (P < 0.001), pruritus (p < 0.001), chest pain (p = 0.001), bronchospasm (p = 0.015), coughing (p = 0.017), headache (p < 0.001), dizziness (p < 0.001), convulsion (p = 0.035) and hypotension (p = 0.001). Based on Naranjo’s algorithm, 226 events were judged to be NAC-related – 31.1% probably and 67.9% possibly drug-related. None of the events were definitely drug-related. Conclusion: Adverse drug reactions to IV-NAC were common among patients with acetaminophen overdose but mostly minor, and that all reported adverse reactions were easily managed.

Samahjabi's picture

Effects of Delay In Infusion of N-Acetylcysteine on Appearance of Adverse Drug Reactions After Acetaminophen Overdose: A Retrospective Study

Journal Title, Volume, Page: 
Pharmacoepidemiology and Drug Safety Volume 19, Issue 10, pages 1064–1070, October 2010
Year of Publication: 
2010
Authors: 
Sa'ed H. Zyoud
Poison Control And Drug Information Center (PCDIC), An-Najah National University, P.O. Box 7, Nablus, Palestine
Rahmat Awang
WHO Collaborating Centre for Drug Information, National Poison Centre, Universiti Sains Malaysia (USM), Penang, Malaysia
Syed Azhar Syed Sulaiman
Clinical Pharmacy Program, College of Pharmaceutical Science, Universiti Sains Malaysia (USM), Penang, Malaysia
Samah W. Al-Jabi
Clinical Pharmacy Program, College of Pharmaceutical Science, Universiti Sains Malaysia (USM), Penang, Malaysia; College of Pharmacy, An-Najah National University, Nablus, Palestine
Current Affiliation: 
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Preferred Abstract (Original): 

Purpose  To investigate the relationship between different types of adverse drug reaction (ADR) and late time to N-acetylcysteine (NAC) infusion in patients presenting to the hospital with acetaminophen overdose.
Methods  This is a retrospective study of patients admitted to the hospital for acute acetaminophen overdose over a period of 5 years (1 January 2004 to 31 December 2008). The primary outcome of interest was the relationship between ADR, if any, and late time to NAC infusion. Parametric and non-parametric tests were used to test differences between groups depending on the normality of the data. SPSS 15 was used for data analysis.
Results  Of 305 patients with acetaminophen overdose, 146 (47.9%) were treated with intravenous NAC and 139 (45.6%) were included in this study. Different types of ADR were observed in 94 (67.6%) patients. Late time to NAC infusion was significantly associated with cutaneous anaphylactoid reactions when compared to patients without this type of ADR (p < 0.001). However, there were no significant differences in time to NAC infusion between patients with and without the following ADR: gastrointestinal reactions (p = 0.11), respiratory reactions (p = 0.77), central nervous reactions (p = 0.64), and cardiovascular reactions (p = 0.63).
Conclusion  Late time to NAC infusion is a risk factor for developing cutaneous anaphylactoid reactions, suggesting, rather than proving, that early NAC infusion (≤8 hours) may be protective against this type of ADR.

Samahjabi's picture

Incidence of Adverse Drug Reactions Induced By N-Acetylcysteine In Patients With Acetaminophen Overdose

Journal Title, Volume, Page: 
Hum Exp Toxicol. 2010 Mar;29(3):153-60. Epub 2010 Jan 13
Year of Publication: 
2010
Authors: 
Sa'ed H Zyoud
Poison Control And Drug Information Center (PCDIC), An-Najah National University, P.O. Box 7, Nablus, Palestine
Rahmat Awang
WHO Collaborating Centre for Drug Information, National Poison Centre, Universiti Sains Malaysia (USM), Penang, Malaysia
Syed Azhar Syed Sulaiman
Clinical Pharmacy program, School of Pharmaceutical Sciences, Universiti Sains Malaysia (USM), Penang, Malaysia
Waleed M Sweileh
Faculty of Pharmacy, An-Najah National University, Nablus, Palestine
Samah W Al-jabi
Clinical Pharmacy program, School of Pharmaceutical Sciences, Universiti Sains Malaysia (USM), Penang, Malaysia
Current Affiliation: 
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Preferred Abstract (Original): 

Background: Intravenous N-acetylcysteine (IV-NAC) is widely recognized as the antidote of choice for acetaminophen overdose. However, its use is not without adverse drug reactions (ADR) that might affect therapeutic outcome or lead to treatment delay. Objective: the aim of this study was to investigate the type and incidence of ADR induced by IV-NAC in patients treated for acetaminophen overdose.
Methods: This is a retrospective study of patients admitted to the hospital for acute acetaminophen overdose over a period of 4 years (1 January 2005 to 31 December 2008). The primary outcome of interest in this study was the occurrence of ADR during NAC administration. Pearson chi-square test or Fisher’s exact test, student’s t test, and Mann-Whitney U test were used in univariate analysis. SPSS 15 was used for data analysis.
Results: Two hundred and fifty five patients were studied. Different types of ADR were observed in 119 (46.7%) cases. Of those patients, 83 (69.7%) had been treated with IV-NAC versus 36 (30.3%) who had not (p < .001). The following ADR were significantly associated with IV-NAC administration: vomiting (p = .001), flushing (p < .001), rash (p < .001), pruritus (p < .001), chest pain (p = .001), bronchospasm (p = .03), coughing (p = .01), headache (p = .001), dizziness (p < .001), convulsion (p = .03), and hypotension (p = .001). ADR were mild in 54 (43.2%), moderate in 17 (13.6%), and severe in 12 (9.6%) patients. There were no ADR in 42 (33.6%) patients. Comparative results of the characteristics of patients who reacted to IV-NAC and nonreactors showed that patients with ADR had no significant difference in age, gender, ethnicity, amount ingested, latency time, and acetaminophen level than nonreactors.
Conclusion: ADR to IV-NAC were common among patients with acetaminophen overdose, but mostly minor and all reported adverse reactions were easily managed.

saedzyoud's picture

Effects of Delay In Infusion of N-Acetylcysteine on Appearance of Adverse Drug Reactions After Acetaminophen Overdose: a Retrospective Study

Journal Title, Volume, Page: 
Pharmacoepidemiology and Drug Safety. Volume 19, Issue 10, October 2010, Pages: 1064–1070
Year of Publication: 
2010
Authors: 
Sa'ed H. Zyoud
WHO Collaborating Centre for Drug Information, National Poison Centre, Universiti Sains Malaysia (USM), Penang, Malaysia
Current Affiliation: 
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Rahmat Awang
WHO Collaborating Centre for Drug Information, National Poison Centre, Universiti Sains Malaysia (USM), Penang, Malaysia
Syed Azhar Syed Sulaiman
Clinical Pharmacy Program, College of Pharmaceutical Science, Universiti Sains Malaysia (USM), Penang, Malaysia
Samah W. Al-Jabi
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Preferred Abstract (Original): 

Purpose:To investigate the relationship between different types of adverse drug reaction (ADR) and late time to N-acetylcysteine (NAC) infusion in patients presenting to the hospital with acetaminophen overdose.
Methods: This is a retrospective study of patients admitted to the hospital for acute acetaminophen overdose over a period of 5 years (1 January 2004 to 31 December 2008). The primary outcome of interest was the relationship between ADR, if any, and late time to NAC infusion. Parametric and non-parametric tests were used to test differences between groups depending on the normality of the data. SPSS 15 was used for data analysis.
Results: Of 305 patients with acetaminophen overdose, 146 (47.9%) were treated with intravenous NAC and 139 (45.6%) were included in this study. Different types of ADR were observed in 94 (67.6%) patients. Late time to NAC infusion was significantly associated with cutaneous anaphylactoid reactions when compared to patients without this type of ADR (p < 0.001). However, there were no significant differences in time to NAC infusion between patients with and without the following ADR: gastrointestinal reactions (p = 0.11), respiratory reactions (p = 0.77), central nervous reactions (p = 0.64), and cardiovascular reactions (p = 0.63(
Conclusion: Late time to NAC infusion is a risk factor for developing cutaneous anaphylactoid reactions, suggesting, rather than proving, that early NAC infusion (≤8 hours) may be protective against this type of ADR.

saedzyoud's picture

Incidence of Adverse Drug Reactions Induced By N-Acetylcysteine In Patients With Acetaminophen Overdose

Journal Title, Volume, Page: 
Hum Exp Toxicol. 2010 Mar; 29(3):153-60. Epub 2010 Jan 13
Year of Publication: 
2010
Authors: 
Zyoud SH
WHO Collaborating Centre for Drug Information, Clinical Toxicology, National Poison Centre, Universiti Sains Malaysia (USM), Penang, Malaysia
Current Affiliation: 
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Awang R
WHO Collaborating Centre for Drug Information, Clinical Toxicology, National Poison Centre, Universiti Sains Malaysia (USM), Penang, Malaysia
Syed Sulaiman SA
WHO Collaborating Centre for Drug Information, Clinical Toxicology, National Poison Centre, Universiti Sains Malaysia (USM), Penang, Malaysia
Al-Jabi SW
WHO Collaborating Centre for Drug Information, Clinical Toxicology, National Poison Centre, Universiti Sains Malaysia (USM), Penang, Malaysia
Preferred Abstract (Original): 

Background:Intravenous N-acetylcysteine (IV-NAC) is widely recognized as the antidote of choice for acetaminophen overdose. However, its use is not without adverse drug reactions (ADR) that might affect therapeutic outcome or lead to treatment delay.
Objective:The aim of this study was to investigate the type and incidence of ADR induced by IV-NAC in patients treated for acetaminophen overdose.
Methods:This is a retrospective study of patients admitted to the hospital for acute acetaminophen overdose over a period of 4 years (1 January 2005 to 31 December 2008). The primary outcome of interest in this study was the occurrence of ADR during NAC administration. Pearson chi-square test or Fisher's exact test, student's t test, and Mann-Whitney U test were used in univariate analysis. SPSS 15 was used for data analysis.
Results: Two hundred and fifty five patients were studied. Different types of ADR were observed in 119 (46.7%) cases. Of those patients, 83 (69.7%) had been treated with IV-NAC versus 36 (30.3%) who had not (p < .001). The following ADR were significantly associated with IV-NAC administration: vomiting (p = .001), flushing (p < .001), rash (p < .001), pruritus (p < .001), chest pain (p = .001), bronchospasm (p = .03), coughing (p = .01), headache (p = .001), dizziness (p < .001), convulsion (p = .03), and hypotension (p = .001). ADR were mild in 54 (43.2%), moderate in 17 (13.6%), and severe in 12 (9.6%) patients. There were no ADR in 42 (33.6%) patients. Comparative results of the characteristics of patients who reacted to IV-NAC and nonreactors showed that patients with ADR had no significant difference in age, gender, ethnicity, amount ingested, latency time, and acetaminophen level than nonreactors.
Conclusion: ADR to IV-NAC were common among patients with acetaminophen overdose, but mostly minor and all reported adverse reactions were easily managed.

Waleed Sweileh's picture

Incidence of Adverse Drug Reactions Induced by N-Acetylcysteine in Patients with Acetaminophen Overdose

Journal Title, Volume, Page: 
Hum Exp Toxicol, 29(3):153-60
Year of Publication: 
2010
Authors: 
Sweileh WM
Faculty of Pharmacy, An-Najah National University, Nablus, Palestine
Current Affiliation: 
College of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Awang R
WHO Collaborating Centre for Drug Information, Clinical Toxicology, National Poison Centre, Universiti Sains Malaysia (USM), Penang, Malaysia
Syed Sulaiman SA
WHO Collaborating Centre for Drug Information, Clinical Toxicology, National Poison Centre, Universiti Sains Malaysia (USM), Penang, Malaysia
Al-Jabi SW
Preferred Abstract (Original): 

BACKGROUND:

Intravenous N-acetylcysteine (IV-NAC) is widely recognized as the antidote of choice for acetaminophen overdose. However, its use is not without adverse drug reactions (ADR) that might affect therapeutic outcome or lead to treatment delay.

OBJECTIVE:

The aim of this study was to investigate the type and incidence of ADR induced by IV-NAC in patients treated for acetaminophen overdose.

METHODS:

This is a retrospective study of patients admitted to the hospital for acute acetaminophen overdose over a period of 4 years (1 January 2005 to 31 December 2008). The primary outcome of interest in this study was the occurrence of ADR during NAC administration. Pearson chi-square test or Fisher's exact test, student's t test, and Mann-Whitney U test were used in univariate analysis. SPSS 15 was used for data analysis.

RESULTS:

Two hundred and fifty five patients were studied. Different types of ADR were observed in 119 (46.7%) cases. Of those patients, 83 (69.7%) had been treated with IV-NAC versus 36 (30.3%) who had not (p < .001). The following ADR were significantly associated with IV-NAC administration: vomiting (p = .001), flushing (p < .001), rash (p < .001), pruritus (p < .001), chest pain (p = .001), bronchospasm (p = .03), coughing (p = .01), headache (p = .001), dizziness (p < .001), convulsion (p = .03), and hypotension (p = .001). ADR were mild in 54 (43.2%), moderate in 17 (13.6%), and severe in 12 (9.6%) patients. There were no ADR in 42 (33.6%) patients. Comparative results of the characteristics of patients who reacted to IV-NAC and nonreactors showed that patients with ADR had no significant difference in age, gender, ethnicity, amount ingested, latency time, and acetaminophen level than nonreactors.

CONCLUSION:

ADR to IV-NAC were common among patients with acetaminophen overdose, but mostly minor and all reported adverse reactions were easily managed.

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