Cases of Angiotensin Receptor Blocker (ARB) Related Sprue-Like Enteropathy (SE): A Review of the Food and Drug Administration Adverse Event Reporting System (FAERS): 1174

INTRODUCTION: In 2002, olmesartan, an ARB, was introduced to the market as Benicar. In 2012, Rubio-Tapia et al. reported 22 cases of SE related to olmesartan. In 2013, the Food and Drug Administration (FDA) issued a safety warning about SE related to olmesartan. In August 2017, Benicar’s manufacturer paid $300 million to settle claims from about 2,300 plaintiffs in SE cases. The FAERS is a publicly available database for voluntary reporting of adverse drug events to the FDA. No study has summarized the reports of ARB-related SE to the FAERS. Our aim is to establish the timeline of FAERS reports of SE from ARBs and to further characterize reports of olmesartan and another ARB-related SE to the FAERS. METHODS: A total of 9,144,290 FAERS reports from January 2013 to December 2018 were downloaded. Data was first queried for all patients using an ARB for hypertension. All drugs were limited to those defined as “Primary Suspect”. Gastrointestinal adverse events (GIAE), including SE and control reactions were then obtained for all ARBs and searched by both generic and trade names. Information regarding the timeline of reports and demographics of reporters was collected. Reporters are categorized as physicians, pharmacists, other health care professionals, consumers, and attorneys. RESULTS: A total of 77,245 FAERS reports of people for ARBs were analyzed. SE was identified in 5,290 (6.8%) cases. With the exception of 6 cases, all were related to olmesartan. All olmesartan cases were filed under its trade name Benicar. In addition to the SE cases reported, there were 7,402 (9.6%) cases of GIAE related to ARB. These included drugs other than olmesartan. The number of reports filed by each category each year is shown in Table 1 and Figure 1. Cases of SE were followed, and their outcomes identified (Table 2). Hospitalization was reported in 52.7% and death in 0.9%. CONCLUSION: The FDA reports for olmesartan-related SE and ARB-related GIAE have increased dramatically. Unlike some high-profile cases with dramatically increased lawyer reporting, these reports originate from physicians and consumers. All reports were for Benicar, none for generics and a few reports for combinations. This can be explained by the minimum of 2 years of ARB use prior symptoms onset suggested in the literature. Other explanations include Benicar’s large market share or potential problems with the Benicar formulation.