Drug-induced liver injury associated with antiseizure medications from the FDA Adverse Event Reporting System (FAERS)

Kamitaki, Brad K.; Minacapelli, Carlos D.; Zhang, Pengfei; Wachuku, Christopher; Gupta, Kapil; Catalano, Carolyn; Rustgi, Vinod K.

doi:10.1016/j.yebeh.2021.107832

Cited by 38 publications

(34 citation statements)

References 29 publications

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“…The FDA Adverse Event Reporting System (FAERS), a postmarketing database, is used to store AE reports associated with FDA-approved therapy reported spontaneously in the real world by healthcare professionals or patients and lawyers. The pharmacovigilance system of FAERS was critical for continuous monitoring of the relationship between AEs and drugs ( Kamitaki et al, 2021 ). Therefore, this study was based on the FAERS database.…”

Section: Introductionmentioning

confidence: 99%

Anaplastic Lymphoma Kinase Tyrosine Kinase Inhibitor-Associated Cardiotoxicity: A Recent Five-Year Pharmacovigilance Study

et al. 2022

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Background: Clinical trials frequently reported anaplastic lymphoma kinase tyrosine kinase inhibitors (ALK-TKIs) associated with cardiac adverse drug events (AEs) but minimal postmarketing data. We aimed to research real-world cardiac disorders associated with ALK-TKIs based on the Food and Drug Administration Adverse Event Reporting System (FAERS).Methods: Extract reports from the FAERS from the first quarter of 2016 to the second quarter of 2021 were obtained. Data mining of cardiac disorders associated with ALK-TKIs was carried out using disproportionality analysis to determine the clinical characteristics of AEs.Results: In total, 605 cases were screened out. These events were found to be more prevalent in patients ≥45 years (50.74%) and women (50.74%). The onset time of cardiac disorders was variable and concentrated within 2 months, with a median time of 33 days. The outcomes tended to be poor, with 20.93% fatality proportion. Cardiac arrhythmia was a common adverse event of ALK-TKIs, especially bradycardia. Crizotinib and lorlatinib showed positive signals in cardiac disorders, especially in heart failure, and brigatinib presented no signals. The study also found that myocarditis caused by ceritinib and cardiomyopathy caused by lorlatinib may be potential new adverse drug reactions.Conclusion: ALK-TKIs were reported more frequently in cardiotoxicity than other drugs and could often manifest earlier. We also found potential new AE signals in specific drugs and need more clinical studies to confirm. Our study helps fill the safety information of ALK-TKIs in the heart and provides directions for further research.

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Section: Introductionmentioning

confidence: 99%

Anaplastic Lymphoma Kinase Tyrosine Kinase Inhibitor-Associated Cardiotoxicity: A Recent Five-Year Pharmacovigilance Study

et al. 2022

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“…Increasing evidences indicate that phenobarbital is associated with direct hepatoxicity. By analyzing 2.6 million adverse event reports made from the FDA Adverse Event Reporting System (FAERS) database between July 1, 2018 and March 31, 2020 for drug-induced liver injury (DILI) due to antiseizure medications (ASMs), the reporting odds ratio (ROR) of DILI for phenobarbital versus all non-ASM reports is 2.91 (CI:2.24-3.77, p<0.0001) [37]. Mitochondrial toxicity and oxidative stress is involved in the hepatotoxicity induced by phenobarbital [38,39].…”

Section: Discussionmentioning

confidence: 99%

Phenobarbital is Associated with Cholestasis in low birth weight Infants with Hemo-dynamically Significant Patent Ductus Arteriosus

Shen

Huang

Peng

et al. 2022

Preprint

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Objectives: This retrospective cohort study aimed to assess whether phenobarbital was associated with cholestasis in low birth weight (LBW) infants with hemo-dynamically significant patent ductus arteriosus (hsPDA).Methods: This study included 148 LBW infants (24~34 weeks, birth weight<2000 g) diagnosed with hsPDA, admitted to neonatal intensive care unit (NICU) from September 2016 to September 2019. Of the 148 infants, twenty infants were diagnosed with cholestasis. To assess the independent association with cholestasis or direct bilirubin, binary logistic or multivariable linear regression was done, adjusting for major confounders (birth weight, gestational age, critical risk index for babies, invasive mechanical ventilation, any sepsis onset in 28 days and etc). Result: Binary logistic regression analysis was done adjusting for 12 related confounders. After adjustment, the “delay of full enteral feeding” was still associated with “duration of phenobarbital” (DOP) (OR: 1.571; P = 0.015) or “duration of phenobarbital before cholestasis onset” (DOPBCO) (OR: 1.662; P = 0.014); Cholestasis was still associated with “DOP” (OR: 1.553; P = 0.005) or “DOPBCO” (OR: 1.353; P = 0.088); “High direct bilirubin summit” (>1.5 mg/dl) was still associated with “DOP” (OR: 1.686; P = 0.003) or “DOPBCO” (OR: 1.511; P = 0.021). Multivariate linear regression revealed that “persist time of cholestasis” was associated with “DOB” (B: 2.254; P = 0.050) after adjustment of “delay of full enteral feeding”.Conclusion: This study found that phenobarbital was associated with neonatal cholestasis in LBW infants with hsPDA. Phenobarbital should be used cautiously in this population.

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“…Lamotrigine (LTG) Among the others commonly used antiepileptic drugs as MS, the use of LTG seems to be the safest in the context of the risk of the development of NAFLD, as it leads to a lower degree of weight gain and lipid metabolism disorders [54,82]. Also, as in the case of CBZ, the use of LTG is associated with the risk of hepatotoxicity and the development of DILI through idiosyncrasy [86,87].…”

Section: Carbamazepine (Cbz)mentioning

confidence: 99%

“…There is little scientific evidence of the use of lithium and the risk of NAFLD. Lithium therapy may be associated with weight gain and hypothyroidism, which can lead to glucose intolerance and dyslipidemia, and this may secondarily translate into the occurrence of the fatty liver [54,86,88].…”

Section: Lithiummentioning

confidence: 99%

The development of the Metabolic-associated Fatty Liver Disease during pharmacotherapy of mental disorders - a review

Rogalski

Subdys

Gawlik-Kotelnicka

2022

Current Problems of Psychiatry

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Introduction: Metabolic-associated Fatty Liver Disease (MAFLD) is a term for Non-alcoholic Fatty Liver Disease (NAFLD) that highlights its association with components of the Metabolic Syndrome (MetS). MAFLD is becoming a clinically significant problem due to its increasing role in the pathogenesis of cryptogenic cirrhosis of the liver. Material and methods: The resulting work is a review of the most important information on the risk of MAFLD development in the context of the use of particular groups of psychotropic drugs. The study presents the epidemiology, with particular emphasis on the population of psychiatric patients, pathophysiology and scientific reports analyzing the effect of the psychotropic medications on MAFLD development. Results: The drugs that can have the greatest impact on the development of MAFLD are atypical antipsychotics, especially olanzapine, and mood stabilizers (MS) - valproic acid (VPA). Their effect is indirect, mainly through dysregulation of organism’s carbohydrate and lipid metabolism. Conclusions: The population of psychiatric patients is particularly vulnerable to the development of MAFLD. At the root of this disorder lies the specificity of mental disorders, improper dietary habits, low level of physical activity and tendency to addictions. Also, the negative impact of the psychotropic drugs on the systemic metabolism indirectly contributes to the development of MAFLD. In order to prevent fatty liver disease, it is necessary to monitor metabolic and liver parameters regularly, and patients should be screened by ultrasound examination of the liver. There are also important preventive actions from the medical professionals, including education of patients and sensitizing to healthy lifestyle.

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Drug-induced liver injury associated with antiseizure medications from the FDA Adverse Event Reporting System (FAERS)

Cited by 38 publications

References 29 publications

Anaplastic Lymphoma Kinase Tyrosine Kinase Inhibitor-Associated Cardiotoxicity: A Recent Five-Year Pharmacovigilance Study

Anaplastic Lymphoma Kinase Tyrosine Kinase Inhibitor-Associated Cardiotoxicity: A Recent Five-Year Pharmacovigilance Study

Phenobarbital is Associated with Cholestasis in low birth weight Infants with Hemo-dynamically Significant Patent Ductus Arteriosus

The development of the Metabolic-associated Fatty Liver Disease during pharmacotherapy of mental disorders - a review

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