Pharmacovigilance analysis of small bowel bleeding associated with NSAIDs

Area of Science:

• Pharmacovigilance
• Gastroenterology
• Drug Safety

Background:

• Factors influencing small bowel bleeding from nonsteroidal anti-inflammatory drugs (NSAIDs) are not fully understood.
• NSAID-induced enteropathy remains a significant clinical concern.

Purpose of the Study:

• To assess NSAID-associated small bowel bleeding using pharmacovigilance data.
• To evaluate the influence of co-administered drugs on NSAID-induced small bowel bleeding.
• To provide insights for clinical practice regarding NSAID safety.

Main Methods:

• Retrospective analysis of NSAID-associated small bowel bleeding data from FDA FAERS and Japan's JADER databases (2004-2023).
• Utilized the reporting odds ratio (ROR) to detect adverse reaction signals.
• Employed Chi-square tests to compare drug combination risks.

Main Results:

• Multiple NSAIDs were associated with small bowel bleeding.
• Proton pump inhibitors (PPIs) did not significantly alter NSAID-associated small bowel bleeding risk in FAERS.
• Rebamipide and probiotics showed a decreased risk of NSAID-associated small bowel bleeding in JADER.
• Older adults and males exhibited increased risk signals for aspirin-associated small bowel bleeding.

Conclusions:

• Proton pump inhibitors (PPIs) do not appear to significantly impact NSAID-associated small bowel bleeding.
• Rebamipide and probiotics may have a protective effect against NSAID-induced small bowel bleeding.
• Age and sex are identified as risk factors for aspirin-associated small bowel bleeding, particularly in older males.