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Disproportionality analysis of quinolone safety in children using data from the FDA adverse event reporting system
Wenqiang Kong1, Wei Mao2, Lin Zhang3
1Department of Pharmacy, Zigong First People's Hospital, Zigong, China.
Insights
This study analyzed FDA adverse event reports to identify safety concerns with quinolones in children. Unexpected adverse events associated with ozenoxacin highlight the need for vigilant monitoring in pediatric patients.
Area of Science:
- Pharmacovigilance
- Pediatric Safety
- Drug Adverse Events
Background:
- Quinolones are frequently prescribed for pediatric infections.
- Understanding quinolone-associated adverse events (AEs) in children is crucial for patient safety.
- Continued surveillance of safety data is essential for pediatric pharmacovigilance.
Purpose of the Study:
- To characterize the safety profiles of quinolone-associated AEs in children.
- To analyze data from the FDA Adverse Event Reporting System (FAERS) for quinolone use in pediatric populations.
- To identify potential safety signals and trends in pediatric quinolone use.
Main Methods:
- Utilized FAERS data from Q1 2004 to Q1 2022.
- Employed the Medical Dictionary for Regulatory Activities (MedDRA) for AE identification.
- Calculated Reporting Odds Ratios (ROR) and Information Component (IC) to detect significant drug-AE associations.
Main Results:
- Analyzed 4,704 quinolone-associated reports, with ciprofloxacin and levofloxacin being most frequent.
- Common AEs included infections, gastrointestinal issues, and blood/lymphatic disorders.
- Identified serious, unexpected AE signals for ozenoxacin, including cardiac arrest and seizures, not listed in its package insert.
Conclusions:
- Findings align with known quinolone AEs but highlight unexpected signals for ozenoxacin in children.
- Unexpected ozenoxacin AE signals warrant active clinical vigilance and pharmacovigilance monitoring.
- Enhanced surveillance is necessary to ensure the safe use of quinolones in pediatric populations.
Background:
Quinolones are widely prescribed for the treatment or prevention of infectious diseases in children. To gain further insight into quinolone-associated adverse event (AE) in children and better protect pediatric patients, continued surveillance of safety data is essential. The purpose of this study was to characterize the safety profiles of quinolone-associated AEs in children by mining the FDA adverse event reporting system (FAERS).
Methods:
FAERS reports from quarter 1 of 2004 to quarter 1 of 2022 were included in the study. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify adverse events. Reporting odds ratios (ROR) corresponding 95% confidence intervals (CIs) and information component (IC) along with 95% CIs were calculated to detect drug-AE pairs with higher-than-expected reporting rates within the FAERS from System Organ Classes (SOCs) to Preferred Terms (PTs). Reports were considered as signals if the 95% confidence interval did not contain the null value.
Results:
After inclusion criteria were applied, a total of 4,704 reports associated with quinolones were considered. Most FAERS reports associated with ciprofloxacin (N = 2,706) followed by levofloxacin (N = 1,191), moxifloxacin (N = 375), oflaxacin (N = 245) and ozenoxacin (N = 187). The most common age group was 12-18 years. The median weight was 39.0 kilogram. The adverse effects of quinolones emerging for SOCs primarily included Infections and infestations, gastrointestinal symptoms, blood and lymphatic system disorders, cardiac disorders, nervous system disorders, musculoskeletal and connective tissue disorders and psychiatric disorders. The most frequently AE signals at the PT level were pyrexia (N = 236), febrile neutropenia (N = 120), off label use (N = 48), drug resistance (N = 18) and cardiac arrest (N = 22) following the use of ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin, and ozenoxacin, respectively. Serious oznoxacin-associated AE signals were found and have not been documented in the package insert. They included cardiac arrest (N = 22; ROR = 19.83; IC = 3.68), overdose (N = 21; ROR = 4.98; IC = 2.07), seizure (N = 16; ROR = 6.01; IC = 2.29), small for dates baby (N = 9; ROR = 14.7; IC = 3.05), completed suicide (N = 15, ROR = 18.87; IC = 3.51), asthma (N = 9; ROR = 6.69; IC = 2.24;) and hypotension (N = 9; ROR = 3.83; IC = 1.68).
Conclusion:
This study provided additional evidence with respect to quinolones-related AEs for children. Generally, the findings of this study are compatible with AEs recorded in package inserts. The unexpected signals of ozenoxacin justify active vigilance by clinicians and timely monitoring by pharmacovigilance experts.
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