214 12-Month Post Marketing Safety Surveillance Data of Chewable Inulin Fiber

Abstract

INTRODUCTION: Most Americans consume only half of the daily fiber recommended by the National Academy of Medicine, which is 25 grams per day of fiber for women and 38 grams per day for men. Fiber has been shown to promote bowel regularity, lower cholesterol, control blood sugar, and maintain body weight. To fill the “fiber gap” many patients use fiber supplements. There is a perception that fiber supplementation can lead to bloating and excess gas production, among other adverse events. This study aimed to examine whether or not a pattern of adverse events was associated with chewable inulin fiber (CIF). METHODS: A call-in number for reporting adverse events (AEs) was provided on bottles of a specific brand of CIF. An independent call center with pharmacovigilance-trained health care personnel in accordance with the FDA and global regulatory guidelines on properly reporting AEs was retained to receive and record customer AEs. The AEs for this study were collected and processed from January 1, 2018 to December 31, 2018. RESULTS: An estimated 809,259 individual patients consumed CIF during the surveillance. An analysis of the data showed that there were no serious AEs reported. Additionally, the self-reporting rate of non-serious AEs was low, with only 23 non-serious events reported by 21 individuals; a rate of 2.8 per 100,000 users. The top reported, non-serious AEs were flatulence, diarrhea, and constipation; however, the rates for these were extremely low (4.9, 3.7, and 1.2 per million, respectively). Two events were reported that were classified as musculoskeletal and connective tissue disorders; however, these were considered to not be related, having no basis for biological plausibility. CONCLUSION: 12 months of monitoring real-world use of CIF in a population of over 800,000 patients demonstrates an extremely low rate of self-reported AEs. Contrary to conventional thinking, the rate of flatulence was remarkably low (4.9 per million users), and can most likely be considered statistical background noise. These data, combined with previous RCTs, indicates that CIF is a safe and effective option for fiber supplementation.