PMID- 31656045 OWN - NLM STAT- MEDLINE DCOM- 20210728 LR - 20240328 IS - 1365-2125 (Electronic) IS - 0306-5251 (Print) IS - 0306-5251 (Linking) VI - 86 IP - 1 DP - 2020 Jan TI - Adverse events following cannabis for medical use in Tuscany: An analysis of the Italian Phytovigilance database. PG - 106-120 LID - 10.1111/bcp.14140 [doi] AB - 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. CI - (c) 2019 The British Pharmacological Society. FAU - Crescioli, Giada AU - Crescioli G AD - Department of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, Florence, Italy. FAU - Lombardi, Niccolo AU - Lombardi N AUID- ORCID: 0000-0001-5259-2026 AD - Department of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, Florence, Italy. FAU - Bettiol, Alessandra AU - Bettiol A AD - Department of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, Florence, Italy. FAU - Menniti-Ippolito, Francesca AU - Menniti-Ippolito F AD - National Centre for Drug Research and Evaluation, National Institute of Health, Rome, Italy. FAU - Da Cas, Roberto AU - Da Cas R AD - National Centre for Drug Research and Evaluation, National Institute of Health, Rome, Italy. FAU - Parrilli, Maria AU - Parrilli M AD - Regional Centre for Pharmacovigilance, Azienda USL Toscana Centro, Florence, Italy. FAU - Del Lungo, Martina AU - Del Lungo M AD - Department of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, Florence, Italy. AD - Regional Centre for Pharmacovigilance, Azienda USL Toscana Centro, Florence, Italy. FAU - Gallo, Eugenia AU - Gallo E AD - Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy. AD - Research and Innovation Center in Phytotherapy and Integrated Medicine - CERFIT, Referring Center for Phytotherapy of Tuscany Region, Careggi, University Hospital, Florence, Italy. FAU - Mugelli, Alessandro AU - Mugelli A AD - Department of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, Florence, Italy. FAU - Maggini, Valentina AU - Maggini V AD - Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy. AD - Research and Innovation Center in Phytotherapy and Integrated Medicine - CERFIT, Referring Center for Phytotherapy of Tuscany Region, Careggi, University Hospital, Florence, Italy. FAU - Firenzuoli, Fabio AU - Firenzuoli F AD - Research and Innovation Center in Phytotherapy and Integrated Medicine - CERFIT, Referring Center for Phytotherapy of Tuscany Region, Careggi, University Hospital, Florence, Italy. FAU - Vannacci, Alfredo AU - Vannacci A AUID- ORCID: 0000-0003-1911-2021 AD - Department of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, Florence, Italy. LA - eng PT - Journal Article DEP - 20200103 PL - England TA - Br J Clin Pharmacol JT - British journal of clinical pharmacology JID - 7503323 SB - IM MH - Adverse Drug Reaction Reporting Systems MH - *Cannabis/adverse effects MH - Databases, Factual MH - *Drug-Related Side Effects and Adverse Reactions MH - Female MH - Humans MH - Italy/epidemiology MH - Middle Aged PMC - PMC6983517 OTO - NOTNLM OT - adverse drug reactions OT - clinical pharmacology OT - drug safety OT - general practice OT - medical cannabis EDAT- 2019/10/28 06:00 MHDA- 2021/07/29 06:00 PMCR- 2021/01/01 CRDT- 2019/10/28 06:00 PHST- 2019/05/09 00:00 [received] PHST- 2019/09/02 00:00 [revised] PHST- 2019/09/11 00:00 [accepted] PHST- 2019/10/28 06:00 [pubmed] PHST- 2021/07/29 06:00 [medline] PHST- 2019/10/28 06:00 [entrez] PHST- 2021/01/01 00:00 [pmc-release] AID - BCP14140 [pii] AID - 10.1111/bcp.14140 [doi] PST - ppublish SO - Br J Clin Pharmacol. 2020 Jan;86(1):106-120. doi: 10.1111/bcp.14140. Epub 2020 Jan 3.