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Aims: Several cases of acute non‐infectious cholestatic hepatitis recently appeared in Italy following consumption of Curcuma longa‐containing dietary supplements. The aim of this research was to describe the Tuscan (Italy) cases of acute hepatitis and to compare them with similar cases of hepatotoxicity published in the literature by performing a systematic review. Methods: Records of Tuscan cases of acute hepatitis were obtained from the Italian Phytovigilance system. Each spontaneous report was analysed in order to collect all relevant clinical information of patients and information concerning the Curcuma longa‐containing dietary supplement. Moreover, both the RUCAM and WHO‐UMC systems were used to evaluate the causal relationship between the use of dietary supplement and acute hepatitis. A systematic literature review was performed in MEDLINE and Embase and all case‐reports and case‐series published in English were included. Results: Seven cases of acute hepatitis occurring in Tuscany up to September 2019 are described. In all cases, hepatotoxicity was associated with Curcuma longa formulations with high bioavailability and high dosage of curcumin/curcuminoids. The causal relationship was also supported by the positive dechallenge observed in most cases. In the 23 cases identified through the systematic review, the majority of patients were concomitantly exposed to at least one other medication and 16 of them experienced a positive dechallenge. Conclusions: Within the frame of poorly controlled and regulated products, such as dietary supplements, the evaluation of Italian cases of Curcuma longa‐induced acute hepatitis and the systematic review of literature confirmed the association between Curcuma longa and liver injury. [ABSTRACT FROM AUTHOR]

Aims: Despite a significant increase in using cannabis for medical purposes, current evidence on its safety in real‐world clinical practice is still poorly characterised. By a case‐by‐case analysis of spontaneous reports of suspected adverse events (AEs) collected in Tuscany within the Italian Phytovigilance database, the aim of the present study was to describe AEs occurred in patients exposed to medical cannabis. Methods: We evaluated all reports of cannabis‐related suspected AEs collected within the Phytovigilance database up to December 2018. Information regarding cannabis therapy, patient's demographic and clinical characteristics, concomitant medications, AE description according to the Medical Dictionary for Regulatory Activities (MedDRA) classification, AE seriousness and AE outcome, were collected. The causality assessment was performed following World Health Organisation–Uppsala Monitoring Centre criteria. Results: Fifty‐three cannabis‐related AE reports were analysed. The majority of patients were females (77.3%), with a mean age of 61.9 years. Thirty‐nine (73.6%) cases were defined as nonserious and the majority of them (86.9%) showed a complete resolution or improvement. Forty‐six (86.8%) cases were judged as probably related to cannabis consumption. The most frequently reported system organ class was psychiatric and nervous system disorders, and a potential drug–drug interaction was present in 16 cases. Conclusion: Cannabis was generally well tolerated and the majority of AEs were mild and transient. Our analysis highlighted important safety issues for clinical practice, in particular the need for an accurate prescription monitoring during the titration phase, particularly in the presence of concomitant medications. [ABSTRACT FROM AUTHOR]