Objective: We describe a case of severe hypoglycemia in a 14-month-old child as a suspected adverse drug reaction (ADR) to nadolol, and we performed an analysis of the FDA Adverse Event Reporting System (FAERS) database. Although previous reports have identified the risk of severe hypoglycemia in children during treatment with β-blockers, little is known about hypoglycemia as an ADR in infants treated with nadolol. Moreover, the pharmacodynamic and pharmacokinetic profiles of nadolol in children aged less than 1 year old are still not fully known.
Materials And Methods: We extracted all ADR reports involving nadolol from the FAERS database; in order to reduce the risk of bias, we only considered cases that exclusively reported nadolol as the suspect drug. We then selected cases of hypoglycemia in the pediatric population and conducted a manual deduplication.
Results: Upon FAERS database analysis, a total of 2,674 suspected ADR reports to nadolol were found. Of these, 1,950 (73%) were solely attributed to nadolol, and 63 of them were hypoglycemic events. A total of 47 reports included the relevant pediatric age (74.6%). After deduplication, we identified 25 cases (mean age: 3.65 years old); all of these reports were categorized as serious, and hospitalization was required in 15 cases.
Conclusion: Hypoglycemia is a reported life-threatening ADR associated with nadolol, especially in infants, in whom this drug should be used with caution.
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http://dx.doi.org/10.5414/CP203786 | DOI Listing |
Expert Opin Drug Saf
December 2024
Department of Urology, West China Hospital, Sichuan University, Chengdu, China.
Background: Drug-induced nephrolithiasis is a recognized complication in clinical practice. The objective of this study is to identify drugs that are significantly associated with an increased risk of inducing nephrolithiasis based on the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).
Research Design And Methods: We collected adverse event reports associated with drug-induced nephrolithiasis from the first quarter of 2004 (2004 Q1) to the fourth quarter of 2023 (2023 Q4) in the FAERS database.
Arch Womens Ment Health
December 2024
College of Pharmacy, Jinan University, Guangzhou, Guangdong, China.
Purpose: This study investigates the potential association between commonly prescribed psychotropic medications, such as Atypical Antipsychotics (AAs), Selective Serotonin Reuptake Inhibitors (SSRIs), and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), and congenital anomalies in newborns. The analysis uses data from the Food and Drug Administration Adverse Event Reporting System (FAERS).
Methods: Spontaneously reported cases of congenital anomalies in newborns (under 28 days old) were extracted from the FAERS database, covering January 2004 to June 2023.
Expert Opin Drug Saf
December 2024
Department of Pharmacy, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Background: Recent clinical case reports have generated controversy concerning the adverse events (AEs) of amputation linked to sodium-glucose co-transporter 2 inhibitors (SGLT2i). We assessed the risk of osteomyelitis AE reporting linked to SGLT2i or SGLT2i-metformin co-medication.
Research Design And Methods: Investigated the FDA Adverse Event Reporting System for osteomyelitis-related AEs associated with SGLT2i or SGLT2i-metformin co-medication from 2013q2 to 2023q1.
Expert Opin Drug Saf
December 2024
Department of Cardiology, The First Affiliated Hospital of Jinan University, Guangzhou, China.
Background: Ezetimibe is known for its lipid-lowering safety and tolerability, but its real-world adverse effects have not been fully evaluated. In this study, adverse events associated with ezetimibe were investigated using the FAERS database for the period 2004 to 2023.
Research Design And Methods: Adverse events data for ezetimibe, spanning from the first quarter of 2004 to the fourth quarter of 2023, were standardized and analyzed using signal quantification methods like Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (EBGM).
Expert Opin Drug Saf
December 2024
Department of Dermatology, Third Xiangya Hospital, Central South University, Changsha, China.
Background: Ruxolitinib cream, a topical Janus kinase (JAK) inhibitor, is a widely used treatment for various dermatological diseases. This study employs the FDA Adverse Event Reporting System (FAERS) database to examine adverse events (AEs) associated with ruxolitinib cream.
Methods: This study employed disproportionate analysis methods, including reported odds ratio and proportional reporting ratio, to collate AEs reported from the fourth quarter of 2021 to the first quarter of 2024.
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