Related Experiment Video
Updated: May 7, 2025
Author Spotlight: Genetic Profiling for Fluorouracil Response in Gastric Cancer
Published on: May 10, 2024
A pharmacovigilance study of the association between proton pump inhibitors and tumor adverse events based on the FDA
Ya-Jun Zhang1, Dan-Dan Duan2, Qian-Yu Tian1
1Department of Pharmacy, The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, Luoyang, China.
Background:
Proton pump inhibitors (PPIs) are effective treatments for acid-related disorders but may pose tumor risks with long-term use. Current research on PPI-associated tumor adverse events (TAEs) is limited and inconclusive. This study aims to comprehensively analyze the relationship between PPIs and TAEs.
Methods:
We analyzed PPI adverse reaction reports from the FDA Adverse Event Reporting System (FAERS) database spanning from 2004 to 2024, focusing on five commonly used PPIs: esomeprazole, pantoprazole, lansoprazole, omeprazole, and rabeprazole. We conducted a disproportionality analysis utilizing the Reporting Odds Ratio (ROR) to identify potential TAEs associated with PPIs. We conducted univariate logistic regression analysis to explore the influencing factors.
Results:
A total of 3,133 TAEs were identified, representing 2.36% of all PPI-related adverse events (AEs). The most common TAEs were gastric cancer (19.05%) and malignant neoplasm (7.23%). Disproportionality analysis revealed ten significant TAEs associated with PPIs, including gastric adenocarcinoma and renal cell carcinoma. The median age of those reporting TAEs was 59 (interquartile range [IQR]: 51-70), and 29.70% of them resulted in a fatality. TAEs associated with PPIs were less likely to occur in elderly patients (65-75: OR = 0.91 [0.87-0.95], p < 0.001; >75: OR = 0.93 [0.89-0.98], p < 0.01).
Conclusion:
TAEs constitute a small but significant fraction of PPI-related AEs. This study highlights the need for cautious long-term use of PPIs and further research to understand the underlying mechanisms and risk factors. Clinicians should be aware of the potential tumor risks associated with prolonged PPI treatment.
Related Concept Videos
01:19Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
01:13Acid Suppressive Drugs for Peptic Ulcer Disease: Proton Pump Inhibitors
Gastric acid, a potent cocktail of hydrogen and chloride ions, is produced in specialized parietal cells within the...
01:26Peptic Ulcer Disease IV: Management
The therapeutic approach involves ensuring adequate rest, implementing drug therapy, promoting smoking cessation, making dietary modifications, and emphasizing long-term follow-up care.
Pharmacological management
The prevailing therapy for peptic ulcers involves a combination of managing the patient's current...
01:30Peptic Ulcer Disease I: Introduction
An acute ulcer, marked by superficial erosion and minimal inflammation, swiftly resolves upon identifying and addressing the underlying cause. In contrast, a chronic ulcer persists, potentially eroding through the muscular wall and forming fibrous tissue.
Peptic ulcers can also be...
01:20Drugs for Peptic Ulcer Disease: Prostaglandin Analogs as Mucosal Protective Agents
Non-steroidal anti-inflammatory drugs (NSAIDs) can induce peptic ulcers by inhibiting cyclooxygenase, decreasing...
01:28Acid Suppressive Drugs for Peptic Ulcer Disease: Histamine H2-Receptor Antagonists