Renal Disorders with Oral Tyrosine Kinase Inhibitors in Metastatic Colorectal Cancer: An Analysis from the FDA Adverse Event Reporting System Database

Russo, Giulia; Barbieri, Maria Antonietta; Sorbara, Emanuela Elisa; Cicala, Giuseppe; Franchina, Tindara; Santarpia, Mariacarmela; Silvestris, Nicola; Spina, Edoardo

doi:10.3390/biomedicines11082311

Cited by 1 publication

(1 citation statement)

References 53 publications

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“…Each report includes various data points, such as an identi cation number, patient information, reporting date, reporting country, quali cations of the primary reporter, suspected and concomitant drugs, date of onset of AEs, seriousness, and description of each AE coded by Preferred Term (PT) from the Medical Dictionary for Regulatory Activities (MedDRA® 26.0), grouped by System Organ Class (SOC). 23 The informative structure of the FAERS database adheres to the international safety reporting guidelines issued by the International Conference on Harmonization (ICH E2B).…”

Section: Data Sourcementioning

confidence: 99%

Adverse event analysis and signal detection of calcitonin gene-related peptide inhibitors using the FDA Adverse Event Reporting System database

Lee,

Ok,

Lee

et al. 2024

Preprint

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Background Calcitonin gene-related peptide (CGRP) inhibitors have been FDA-approved for migraine prophylaxis and relief. However, their safety profile remains uncertain. This study analyzes adverse events (AEs) and signals of disproportionate reporting (SDRs) using the FDA Adverse Event Reporting System (FAERS). Methods We examined AEs reported to FAERS from the approval date to August 2023, standardizing data using preferred terms and system organ classes (SOCs). Disproportionality analyses, including reporting odds ratio (ROR), proportional reporting ratio (PRR) and information component (IC), were used to quantify SDRs. Inclusion in FDA prescribing information was also checked. Results Potential safety signals for monoclonal antibodies, not listed in FDA prescribing information, included psychiatric disorders (e.g., depression - erenumab: ROR 1.97; 95% CI 1.78–2.17) and vascular disorders (e.g., hypertension - erenumab: ROR 1.44; 1.29–1.62). Epitinezumab was associated with throat irritation (ROR 36.94; 30.66–44.52). Commonly reported SOCs included general disorders and administration site conditions (27,578 events; 43.68%), injury, poisoning and procedural complications (26,201 events; 41.5%), and nervous system disorders (15,788 events; 25.01%). Conclusion This study highlights CGRP inhibitor-associated AEs, underscoring the need for clinical monitoring and risk identification. Early detection of AEs and SDRs can inform protective measures to enhance patient safety.

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Section: Data Sourcementioning

confidence: 99%