Detection and Assessment of Herb-Drug Interactions: SFDA Experience

• Published in: Drug safety Vol. 46; no. 4; pp. 420 - 421
• Main Authors: Alghamdi, W, Alghamdi, E, Alghamdi, M, AL-FADEL, N, Alharbi, F
• Format: Journal Article
• Language: English
• Published: Auckland Springer Nature B.V 01.04.2023
• Subjects: Case reports; Drug interaction; Drug interactions; Etoposide; Evaluation; Green tea; Herbal medicine; Herbs; Liquorice; Pharmacovigilance; Product information; Safety; Side effects; Tacrolimus; Thiazides; Saudi Arabia
• ISSN: 0114-5916; 1179-1942

Introduction: There is a general perception of safety and efficacy of herbal medicines that are better than conventional medicines because they are natural [1-3]. Moreover, limited studies addressed drugherbal interactions in the literature. The Saudi Food and Drug Authority (SFDA) established the Drug-Herbal Interaction Project to detect and assess drug-herbal interactions to ensure safety use of these medications. The aim of this project is to detect safety signals related to drug-herbal interaction and assess these signals based on available scientific evidence. Methods: First, a list of SFDA registered herbal products (n=30) were selected and prioritized based on commonly used herbs in Saudi Arabia. Second, reported drug-herbal interactions were retrieved from the World Health Organization (WHO) global database of individual case safety reports (VigiBase), AdisInsight® and Natural Medicines database. Serious drug-herbal Interaction case reports were gathered for further analysis. We excluded the interactions cases of non-registered=drugs in Saudi Arabia and interactions that are labeled in drug and herbal product information, using SFDA, the U.S. Food and Drug Administration (FDA) and European medicines agency (EMA) duct Finally, comprehensive safety evaluation of potential interaction signals were conducted using several evidence sources including literature, global cases retrieved from VigiBase and local cases retrieved from the adverse drug reactions database of the national pharmacovigilance center at SFDA and other relevant documents. The Drug Interaction Probability Scale (DIPS) scale was used to assess the probability of a causal relationship between the potential drug interactions and the events. The project was performed from January 2021 to October 2022. Results: The project yielded 566 potential drug-herbal interaction signals, and 41 interactions had published evidence and referred for extensive evaluation. The assessment results based on DIPS tool and available evidence were; 24 possibly related (85.5%), 5 probably related (12.1%) and 12 doubtful relation (29.2%) interactions. The recommendations was to include the probable herbal-drug interaction in the local product information of herbal products and medications include Turmeric-Tacrolimus, Etoposide-Echinacea, Ginkgo BilobaIbuprofen, Green Tea-warfarin and Liquorice-thiazides interactions. Conclusion: The drug-herbal interaction project in SFDA successfully improved screening and identification of potential drug-herbal interactions. The action plan of this project can be used in postmarketing activities worldwide to identify potential drug interactions.