College
College of Arts and Sciences
Mentor Information
Dr. Olukemi Akintewe
Description
FAERS is the national database maintained by the FDA in order to monitor the safety of drugs after they reach the market. FAERS supports post-marketing surveillance by helping regulators to detect emerging risks and guide decisions on product labeling changes or further investigations. A systematic review of 21 research articles was conducted, focusing on the population and reasonings behind adverse reports for herbal supplements. Articles were gathered from multiple databases such as Pubmed, ScienceDirect, SpringerNature, and government affiliated websites. This research explored the question, “How do adverse event reports for herbal supplements in FAERS differ across age, race, and geographic location of patients?” This research adds clarity to demographic patterns, especially the vulnerability of older adults and women, highlighting gaps that current literature often overlooks due to incomplete or inconsistent reporting. Younger adults most frequently report supplement-related adverse events, while older adults experience more severe reactions, partly due to comorbidities and polypharmacy. Middle-aged and older women using herbal products show elevated risk. The results of this research demonstrated trends across various age, racial, and geographical groups. By recognizing groups where underreporting of adverse effects from herbal supplements occurred, these disparities could be recognized and addressed. This way, the adverse effects of certain herbal supplements will be more recognized, potentially reducing some of these instances of adverse reactions. Additionally, by highlighting these discrepancies, inaccuracies in available data can be better understood and accounted for in research when analyzing FAERS data on herbal supplements.
Retrospective Analysis of FDA Adverse Event Reporting System (FAERS) for Herbal Supplements
FAERS is the national database maintained by the FDA in order to monitor the safety of drugs after they reach the market. FAERS supports post-marketing surveillance by helping regulators to detect emerging risks and guide decisions on product labeling changes or further investigations. A systematic review of 21 research articles was conducted, focusing on the population and reasonings behind adverse reports for herbal supplements. Articles were gathered from multiple databases such as Pubmed, ScienceDirect, SpringerNature, and government affiliated websites. This research explored the question, “How do adverse event reports for herbal supplements in FAERS differ across age, race, and geographic location of patients?” This research adds clarity to demographic patterns, especially the vulnerability of older adults and women, highlighting gaps that current literature often overlooks due to incomplete or inconsistent reporting. Younger adults most frequently report supplement-related adverse events, while older adults experience more severe reactions, partly due to comorbidities and polypharmacy. Middle-aged and older women using herbal products show elevated risk. The results of this research demonstrated trends across various age, racial, and geographical groups. By recognizing groups where underreporting of adverse effects from herbal supplements occurred, these disparities could be recognized and addressed. This way, the adverse effects of certain herbal supplements will be more recognized, potentially reducing some of these instances of adverse reactions. Additionally, by highlighting these discrepancies, inaccuracies in available data can be better understood and accounted for in research when analyzing FAERS data on herbal supplements.
