Real-World Data in Pharmacovigilance Database Provides a New Perspective for Understanding the Risk of Clostridium difficile Infection Associated with Antibacterial Drug Exposure

Li, Dongxuan; Song, Yi; Bai, Zhanfeng; Xi, Xin; Li, Feng; Zhang, Yang; Qin, Chunmeng; Du, Dongping; Du, Qian; Liu, Songqin

doi:10.3390/antibiotics12071109

Cited by 5 publications

(1 citation statement)

References 36 publications

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“…Therefore, it is S1), which eliminated the obstacles of cross-drug class and cross-PT risk comparison. In addition, in order to present the risk characteristics of a drug as a whole (Li et al, 2023a;Li et al, 2023b), the sum of the number of positive signals for each drug was calculated. Among the 1,088 drugs, 612 drugs have at least one positive ADR signal, which suggests that we need to pay attention to the QT prolongation and TdP risk of these drugs, especially those with multiple positive ADR signals.…”

Section: Discussionmentioning

confidence: 99%

Drug-induced QT prolongation and torsade de pointes: a real-world pharmacovigilance study using the FDA Adverse Event Reporting System database

Li,

Chai,

Wang

et al. 2023

Front. Pharmacol.

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Introduction: Drug-induced QT prolongation and (or) Torsade de Pointes (TdP) is a well-known serious adverse reaction (ADR) for some drugs, but the widely recognized comprehensive landscape of culprit-drug of QT prolongation and TdP is currently lacking.Aim: To identify the top drugs reported in association with QT prolongation and TdP and provide information for clinical practice.Method: We reviewed the reports related to QT prolongation and TdP in the FDA Adverse Event Reporting System (FAERS) database from January 1, 2004 to December 31, 2022, and summarized a potential causative drug list accordingly. Based on this drug list, the most frequently reported causative drugs and drug classes of QT prolongation and TdP were counted, and the disproportionality analysis for all the drugs was conducted to in detect ADR signal. Furthermore, according to the positive–negative distribution of ADR signal, we integrated the risk characteristic of QT prolongation and TdP in different drugs and drug class.Results: A total of 42,713 reports in FAERS database were considered to be associated with QT prolongation and TdP from 2004 to 2022, in which 1,088 drugs were reported as potential culprit-drugs, and the largest number of drugs belonged to antineoplastics. On the whole, furosemide was the most frequently reported drugs followed by acetylsalicylic acid, quetiapine, citalopram, metoprolol. In terms of drug classes, psycholeptics was the most frequently reported drug classes followed by psychoanaleptics, analgesics, beta blocking agents, drugs for acid related disorders. In disproportionality analysis, 612 drugs showed at least one positive ADR signals, while citalopram, ondansetron, escitalopram, loperamide, and promethazine were the drug with the maximum number of positive ADR signals. However, the positive-negative distribution of ADR signals between different drug classes showed great differences, representing the overall risk difference of different drug classes.Conclusion: Our study provided a real-world overview of QT prolongation and TdP to drugs, and the presentation of the potential culprit-drug list, the proportion of reports, the detection results of ADR signals, and the distribution characteristics of ADR signals may help understand the safety profile of drugs and optimize clinical practice.

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Section: Discussionmentioning

confidence: 99%

Drug-induced QT prolongation and torsade de pointes: a real-world pharmacovigilance study using the FDA Adverse Event Reporting System database

Li,

Chai,

Wang

et al. 2023

Front. Pharmacol.

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Drug‐Induced Acute Pancreatitis: A Real‐World Pharmacovigilance Study Using the FDA Adverse Event Reporting System Database

Li,

Wang,

Qin

et al. 2024

Clin Pharma and Therapeutics

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Timely identification and discontinuation of culprit‐drug is the cornerstone of clinical management of drug‐induced acute pancreatitis (AP), but the comprehensive landscape of AP culprit‐drugs is still lacking. To provide the current overview of AP culprit‐drugs to guide clinical practice, we reviewed the adverse event (AE) reports associated with AP in the FDA Adverse Event Reporting System (FAERS) database from 2004 to 2022, and summarized a potential AP culprit‐drug list and its corresponding AE report quantity proportion. The disproportionality analysis was used to detect adverse drug reaction (ADR) signals for each drug in the drug list, and the ADR signal distribution was integrated to show the risk characteristic of drugs according to the ADR signal detection results. In FAERS database, a total of 62,206 AE reports were AP‐related, in which 1,175 drugs were reported as culprit‐drug. On the whole, metformin was the drug with the greatest number of AE reports, followed by quetiapine, liraglutide, exenatide, and sitagliptin. Drugs used in diabetes was the drug class with the greatest number of AE reports, followed by immunosuppressants, psycholeptics, drugs for acid‐related disorders and analgesics. In disproportionality analysis, 595 drugs showed potential AP risk, while 580 drugs did not show any positive ADR signal. According to the positive‐negative distribution of ADR signal for drug classes, the drug class with the greatest number of positive drugs was antineoplastic agents. In this study, we provided the current comprehensive landscape of AP culprit‐drugs from the pharmacovigilance perspective, which can provide reference information for clinical practice.

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Antibacterial-related Clostridium difficile infection

2023

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Real-World Data in Pharmacovigilance Database Provides a New Perspective for Understanding the Risk of Clostridium difficile Infection Associated with Antibacterial Drug Exposure

Cited by 5 publications

References 36 publications

Drug-induced QT prolongation and torsade de pointes: a real-world pharmacovigilance study using the FDA Adverse Event Reporting System database

Drug-induced QT prolongation and torsade de pointes: a real-world pharmacovigilance study using the FDA Adverse Event Reporting System database

Drug‐Induced Acute Pancreatitis: A Real‐World Pharmacovigilance Study Using the FDA Adverse Event Reporting System Database

Antibacterial-related Clostridium difficile infection

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