| アブストラクト | Cannabidiol (CBD) is a multitarget agent possessing anti-inflammatory and antioxidant properties. Unlicensed CBD gained public favor for the care of general health and well-being as well as to get comfort from inflammatory complaints, pain, anxiety, mood, and sleep disorders. Safety profile of unlicensed CBD has been not sufficiently described. For this reason, suspected adverse reactions (SARs) to CBD unlicensed products were analyzed. Serious SARs to unlicensed CBD products in EudraVigilance, a system purchased by the European Medicines Agency, were analyzed for age, sex of the patient, adverse reactions, indication for use, and concomitant drugs. Serious SARs were 18.9% of all adverse events to unlicensed CBD; they were more frequent in men and adult people and, to a less extent, in children (3-11 years). About sex, in EudraVigilance serious Individual Cases Safety Reports of SARs to CBD in men are in the largest number (58.8%) with respect to women. Unlicensed CBD was used in the 38.8% of cases for treatment of epilepsy; more frequent adverse effects were: mental disorders, hepatic disorders, and aggravation of pre-existing epilepsy. Drugs or substances more frequently associated with SARs were the antiepileptics clobazam and valproic acid, followed by cannabis. Results suggest that precautions and appropriate surveillance of adverse effects should be taken when unlicensed CBD is used. |
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| ジャーナル名 | Phytotherapy research : PTR |
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| 投稿日 | 2023/10/6 |
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| 投稿者 | Calapai, Fabrizio; Esposito, Emanuela; Ammendolia, Ilaria; Mannucci, Carmen; Calapai, Gioacchino; Curro, Mariaconcetta; Cardia, Luigi; Chinou, Ioanna |
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| 組織名 | Department of Chemical, Biological, Pharmaceutical and Environmental Sciences,;University of Messina, Messina, Italy.;Department of Clinical and Experimental Medicine, University of Messina, Messina,;Italy.;Department of Biomedical and Dental Sciences and Morphological and Functional;Imaging, University of Messina, Messina, Italy.;Department of Human Pathology of Adult and Childhood "Gaetano Barresi",;Laboratory of Pharmacognosy and Chemistry of Natural Products, Faculty of;Pharmacy, National and Kapodistrian University of Athens, Athens, Greece. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/37800192/ |
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