Signal mining of adverse reactions for neuraminidase inhibitors in pregnant women: a disproportionality analysis based on the FDA adverse event reporting system database - Report - MDSpire
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Signal mining of adverse reactions for neuraminidase inhibitors in pregnant women: a disproportionality analysis based on the FDA adverse event reporting system database
Clinical Report: Adverse Effects of Neuraminidase Inhibitors in Pregnant Women
Overview
This study analyzes adverse events associated with neuraminidase inhibitors (NAIs) in pregnant women using the FDA Adverse Event Reporting System database.
Background
Influenza poses increased risks for pregnant women, leading to severe complications and adverse birth outcomes. Neuraminidase inhibitors are recommended for treating influenza in this population.
Delivery, bronchospasm, pneumothorax, exposure during pregnancy
Key Findings
3,687 adverse drug event reports were analyzed from Q1 2004 to Q3 2025.
Oseltamivir had 3,211 reports, while zanamivir had 471 reports.
Significant adverse events for oseltamivir included complications related to pregnancy and general disorders.
For zanamivir, significant adverse events included respiratory and procedural complications.
The study identified five strongest adverse event signals for both oseltamivir and zanamivir.
Clinical Implications
The findings provide essential data for clinicians regarding the safety of neuraminidase inhibitors in pregnant women. Awareness of potential adverse events can guide treatment decisions and enhance patient safety.
Conclusion
This study contributes valuable insights into the safety profile of neuraminidase inhibitors in pregnant women, supporting their use in clinical practice while highlighting the need for ongoing monitoring of adverse events.