Acute Generalized Exanthematous Pustulosis Caused by Proton Pump Inhibitors: A Real-World Pharmacovigilance Study

Abstract

Objective To explore and compare the associations of different proton pump inhibitors (PPIs) with acute generalized exanthematous pustulosis (AGEP). Methods Data were obtained from the database of Food and Drug Administration's adverse event reporting system (FAERS) from January 2004 to June 2020. Non-proportional analysis and Bayesian analysis were utilized to analyze the signs of AGEP caused by different PPIs. The onset time and prognosis of PPIs-related AGEP were also analyzed. Results A total of 162 cases of AGEP caused by PPIs were reported. The most frequently used PPI was omeprazole (33.95%, 55/162), followed by esomeprazole (29.63%, 48/162) and pantoprazole (26.54%, 43/162). Pantoprazole showed the strongest correlation with AGEP, followed by omeprazole and lansoprazole, while esomeprazole appeared to have a weaker association with AGEP than other PPIs. The median time to the onset of AGEP was 6 (2, 12) days after PPI treatment, and 60.00%-83.33% of patients developed symptoms within 10 days after the medication (except rabeprazole). PPI-associated AGEP generally led to a fatality of 1.86% (3 cases) and a hospitalization rate of 79.50% (128 cases). The hospitalization rate of AGEP patients caused by omeprazole was the highest (91.49%, 43/47), followed by that of pantoprazole (88.37%, 38/43), lansoprazole (85.71%, 12/44), and omeprazole (61.82%, 34/55). Conclusions Our pharmacovigilance study based on the FAERS database demonstrated in detail the risks and characteristics of AGEP caused by different PPIs, which could provide a theoretical basis for rational clinical drug use.

Keywords

• proton pump inhibitors
• acute generalized exanthematous pustulosis
• adverse reactions
• data mining