Hematopoietic adverse events associated with PARP Inhibitors:A FAERS database study.

Expert Opin Drug Saf

Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University.

Published: December 2024

AI Article Synopsis

  • The study aimed to identify and analyze hematopoietic adverse drug reactions (ADRs) linked to four PARP inhibitors: Olaparib, Niraparib, Rucaparib, and Talazoparib, using data from the FDA's FAERS database.
  • Methodology involved data extraction from 2019 to 2024, applying standardized medical terminology to screen ADR signals using various statistical methods.
  • Results showed that hematopoietic reactions mainly occurred within 30 days of treatment, with Niraparib presenting the highest adverse events, indicating the need for careful monitoring and individualized treatment plans for patient safety.

Article Abstract

Objectives: To identify and analyze hematopoietic adverse drug reaction (ADR) signals associated with Olaparib, Niraparib, Rucaparib, and Talazoparib - poly(ADP-ribose) polymerase (PARP) inhibitors - using data from the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) database, providing guidance for rational clinical use.

Methods: ASCII data related to the target drugs were extracted from the FAERS database, covering the period from Q1 2019 to Q2 2024. Standardized MedDRA queries (SMQ) and Preferred Terms (PT) from the MedDRA Adverse Drug Reaction glossary were used for international terminology standardization and localization. ADR signals were screened using the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and the comprehensive MHRA method. The composition ratios of the SMQ data for the four drugs were compared.

Results: The study found that hematopoietic adverse reactions for the four PARP inhibitors were concentrated within 30 days post-treatment, with some latency observed, indicating the need for both short-term and long-term monitoring of hematopoietic cells. The most common hematopoietic system adverse events involved cytopenia and leukopenia. Niraparib had the highest number of adverse events and the strongest signal intensity. Both Olaparib and Talazoparib exhibited strong hematotoxicity signals, necessitating careful consideration of their safety profiles.

Conclusion: Significant differences exist in the number, occurrence, and duration of adverse reactions among the four PARP inhibitors. Clinicians should tailor treatment plans to individual patient conditions to enhance the rationality and safety of PARP inhibitor use.

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http://dx.doi.org/10.1080/14740338.2024.2443781DOI Listing

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