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High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry
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Drug-associated hyperprolactinemia: A comprehensive disproportionality analysis based on the FAERS database.

Jinhua Liu1, Liping Xue1, Xinyi Fang1

  • 1Department of Pharmacy, Fujian Maternity and Child Health Hospital, College of Clinical Medicine for Obstetrics & Gynecology and Pediatrics, Fujian Medical University, Fuzhou, 350001, China; School of Pharmacy, Fujian Medical University, Fuzhou, China.

European Journal of Pharmacology
|March 27, 2025
PubMed
Summary

Hyperprolactinemia (HPRL) is linked to 39 drugs, mainly psychotropic medications. Screening for HPRL should consider individual patient factors like gender and age for better monitoring.

Keywords:
Adverse eventDisproportionality analysisFAERSHyperprolactinemiaPharmacovigilance

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Area of Science:

  • Pharmacovigilance
  • Clinical Pharmacology
  • Drug Safety

Background:

  • Hyperprolactinemia (HPRL) is a significant adverse event requiring vigilant monitoring.
  • Identifying causative medications is crucial for patient safety and risk management.

Purpose of the Study:

  • To identify and rank medications associated with HPRL using FDA Adverse Event Reporting System (FAERS) data.
  • To analyze signal strength, age- and gender-specific differences, and time-to-onset for HPRL-associated drugs.

Main Methods:

  • Disproportionality analysis of FAERS data (2004Q1-2024Q1) to detect drug signals for HPRL.
  • Sensitivity, stratified (age, gender), and time-to-onset (TTO) analyses were performed.

Main Results:

  • 39 drugs were associated with HPRL, predominantly psychotropic medications (13 atypical antipsychotics, 5 typical antipsychotics, 5 SSRIs).
  • Risperidone showed the strongest HPRL signal, followed by amisulpride, paliperidone, fluphenazine, and thioridazine.
  • Females exhibited stronger HPRL signals; signals varied by age group and drug, with earlier onset in females and minors for certain drug classes.

Conclusions:

  • Psychotropic medications are primary drivers of HPRL, with significant variations in risk and onset time based on gender and age.
  • Individualized HPRL screening protocols tailored to specific drug exposures, gender, and age are recommended.