Vasilakes Jake A, Rizvi Rubina F, Zhang Jianqiu, Adam Terrence J, Zhang Rui
Institute for Health Informatics, University of Minnesota, Minneapolis, MN, USA.
College of Pharmacy, University of Minnesota, Minneapolis, MN, USA.
AMIA Jt Summits Transl Sci Proc. 2019 May 6;2019:258-266. eCollection 2019.
Dietary supplement adverse events are potentially severe, yet knowledge regarding the safety of dietary supplements is limited. The CFSAN Adverse Event Reporting System (CAERS) contains records of adverse events attributed to supplements and is potentially useful for dietary supplement pharmacovigilance. This study investigates the feasibility of mining CAERS for dietary supplement adverse events as well as for monitoring the safety of dietary supplement products. Using three online resources, we mapped products in CAERS to their listed ingredients. We then ran four standard signal detection algorithms over the ingredient-adverse event and product-adverse event pairs extracted from CAERS and ranked the detected associations. Comparing 130 signals detected by all four algorithms with a dietary supplement resource, we found evidence for 73 (56%) associations. In addition, some detected product-adverse event signals were consistent with product safety information. We have made a database of the detected adverse events publicly available at https://github.com/zhang-informatics/DDSAE.
膳食补充剂不良事件可能很严重，但关于膳食补充剂安全性的知识却很有限。美国食品药品监督管理局营养产品、标签和膳食补充剂中心不良事件报告系统（CAERS）包含了归因于补充剂的不良事件记录，对膳食补充剂药物警戒可能有用。本研究调查了从CAERS挖掘膳食补充剂不良事件以及监测膳食补充剂产品安全性的可行性。我们利用三个在线资源，将CAERS中的产品与其列出的成分进行了映射。然后，我们对从CAERS中提取的成分-不良事件和产品-不良事件对运行了四种标准信号检测算法，并对检测到的关联进行了排名。将所有四种算法检测到的130个信号与一个膳食补充剂资源进行比较，我们发现了73个（56%）关联的证据。此外，一些检测到的产品-不良事件信号与产品安全信息一致。我们已将检测到的不良事件数据库公开提供在https://github.com/zhang-informatics/DDSAE上。
