Association between proton pump inhibitors and rhabdomyolysis risk: a post-marketing surveillance using FDA adverse event reporting system (FAERS) database

Ali F Altebainawi; Lulwa A Alfaraj; Amjad A Alharbi; Fadwa F Alkhuraisi; Thamir M Alshammari

doi:10.1177/20420986231154075

Association between proton pump inhibitors and rhabdomyolysis risk: a post-marketing surveillance using FDA adverse event reporting system (FAERS) database

Ther Adv Drug Saf. 2023 Feb 27:14:20420986231154075. doi: 10.1177/20420986231154075. eCollection 2023.

Authors

Ali F Altebainawi^{1

2}, Lulwa A Alfaraj³, Amjad A Alharbi¹, Fadwa F Alkhuraisi⁴, Thamir M Alshammari^{5

6}

Affiliations

¹ Pharmaceutical Care Services, King Salman Specialist Hospital, Hail Health Cluster, Ministry of Health, Hail, Saudi Arabia.
² Medication Safety Research Chair, King Saud University, Riyadh, Saudi Arabia.
³ Pharmaceutical Care Services, King Khalid Hospital, Hail Health Cluster, Ministry of Health, Hail, Saudi Arabia.
⁴ Pharmaceutical Care Services, Prince Sultan Cardiac Center, Riyadh, Saudi Arabia.
⁵ College of Pharmacy, Almaarefa University, Riyadh, Saudi Arabia.
⁶ Medication Safety Research Chair, King Saud University, Riyadh 55424, Saudi Arabia.

Abstract

Background: This research aims to explore and compare the signals of rhabdomyolysis from the use of Proton pump inhibitors (PPIs) using the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Methods: Rhabdomyolysis and related terms submitted between 2013 and 2021 were retrieved from the FAERS database. The data were analyzed using the reporting odds ratio (ROR), proportional reporting ratio (PRR), Empirical Bayes Geometric Mean (EBGM) and the information component (IC). The signals of rhabdomyolysis associated with PPIs use were detected in both 3-Hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) utilizers and non-utilizers.

Results: A total of 7,963,090 reports were retrieved and analyzed. Fifty-seven reports linked PPIs to rhabdomyolysis out of 3670 reports from other drugs (non-statin included). The association of rhabdomyolysis and PPIs was significant in both statins included, and non-statin-included reports, although with varying degrees of association. The ROR was 2.5 (95% confidence interval [CI] 1.9-3.2) for PPIs in non-statin-included reports and 2 (95% CI: 1.5-2.6) for PPIs in statin-included reports.

Conclusion: Significant signals of rhabdomyolysis were associated with PPIs. However, its signals were higher in non-statin-included reports compared to statin-included reports.

Plain language summary: Plain language summaryProton Pump Inhibitors and rhabdomyolysis risk Background: The FDA created the FDA Adverse Event Reporting System (FAERS) database to support post-marketing surveillance programs. The FAERS is a computerized database with more than nine million adverse event reports, including all reports from 1969 to the present. This research aims to explore and compare the signals of rhabdomyolysis from the use of proton pump inhibitors (PPIs) using the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database.Research design and methods: We retrieved rhabdomyolysis and related terms submitted between 2013 and 2021 from the FAERS database. Then, we analyzed the data that we found. We detected the signals of rhabdomyolysis associated with PPIs use in both statins utilizers and non-utilizers.Results: We retrieved and analyzed a total of 7,963,090 reports. We found 57 reports linked PPIs to rhabdomyolysis out of 3670 reports from other drugs (non-statin included). The association of rhabdomyolysis and PPIs was significant in both statins included, and non-statin-included reports, although with varying degrees of association.Conclusion: Significant signals of rhabdomyolysis were associated with PPIs. However, its signals were higher in non-statin-included reports than in statin-included reports.

Keywords: adverse drug events; drug safety; pharmacovigilance; post-marketing surveillance; proton pump inhibitors; rhabdomyolysis.