[Increased risk of gastrointestinal bleeding or ulcers when using spironolactone: a case-control study]

Area of Science:

• Pharmacovigilance
• Gastroenterology
• Clinical pharmacology

Context:

• Spironolactone is a medication commonly prescribed for conditions like heart failure and hypertension.
• Upper gastrointestinal (GI) bleeding and ulcers are significant adverse events associated with medication use.

Purpose:

• To investigate the association between spironolactone use and the risk of developing upper GI bleeding or ulcers.
• To quantify the risk increase, if any, associated with spironolactone therapy.

Summary:

• A case-control study utilizing the IPCI database in the Netherlands identified 523 cases of upper GI events and matched them with 5,230 controls.
• Current spironolactone use was linked to a 2.7-fold increased risk of upper GI events (OR: 2.7; 95% CI: 1.2-6.0).
• The risk was notably higher with high-dose spironolactone and when co-administered with ulcerogenic drugs (OR: 7.3; 95% CI: 2.9-18.7).

Impact:

• Findings highlight a significant safety concern for spironolactone users, particularly those on concurrent ulcerogenic medications.
• Clinicians should exercise caution when prescribing spironolactone, considering the potential for serious upper GI complications.
• This research contributes to a better understanding of drug-induced gastrointestinal risks, informing clinical practice and patient safety guidelines.