Adverse events related to herbal dietary supplements and over-the-counter medications containing laxatives: a 10-year update from the Italian Phytovigilance and Pharmacovigilance systems

被引：3

作者：

Lombardi, Niccolo ^{[1
,2
]}

Crescioli, Giada ^{[1
,2
]}

Maggini, Valentina ^{[1
,3
]}

Brilli, Valentina ^{[1
]}

Menniti-Ippolito, Francesca ^{[4
]}

Ippoliti, Ilaria ^{[4
]}

Potenza, Simona ^{[5
]}

Renda, Francesca ^{[5
]}

Mazzanti, Gabriela ^{[6
]}

Vitalone, Annabella ^{[6
]}

Vannacci, Alfredo ^{[1
,2
]}

Firenzuoli, Fabio ^{[3
]}

机构：

[1] Univ Firenze, Dipartimento Neurosci, Psicol, Area Farmaco & Salute Bambino,Sez Farmacol & Toss, Viale G Pieraccini 6, I-50139 Florence, Italy

[2] Ctr Reg Toscano Farmacovigilanza, Florence, Italy

[3] Azienda Osped Univ Careggi, Ctr Ric & Innovaz Fitoterapia & Med Integrata, Ctr Riferimento Fitoterapia, Reg Toscana, Florence, Italy

[4] Ist Super Sanita, Ctr Nazl Ric & Valutaz Preclin & Clin Farm, Rome, Italy

[5] Agenzia Italiana Farmaco Rome, Ufficio Farmacovigilanza, Area Vigilanza Postmkt, Rome, Italy

[6] Sapienza Univ Roma, Dipartimento Fisiol & Farmacol, Rome, Italy

来源：

ANNALI DELL ISTITUTO SUPERIORE DI SANITA | 2022年 / 58卷 / 02期

关键词：

dietary supplement; herbal medicinal product; adverse event; phytovigilance; pharmacovigilance; CONSTIPATION; DIAGNOSIS; ADULTS; BOWEL; CARE;

D O I：

10.4415/ANN_22_02_09

中图分类号：

R1 [预防医学、卫生学];

学科分类号：

1004 ; 120402 ;

摘要：

Introduction. Products containing anthraquinones (AQ) are associated with an increased risk of serious adverse events (AEs). We performed an update of the available evidence retrieved by the spontaneous reports of AE associated with herbal dietary supplement (DS) and over-the-counter medications (OTC-M) used as laxatives. Methods. Analysis and evaluation of AE reports retrieved from the Italian Phytovigilance and Pharmacovigilance systems was performed from February 2011 to December 2020. Results. Totally 110 AE reports, 24 related to herbal DS and 86 to OTC-M, were analyzed. Most subjects were females. Herbal products analyzed mostly contained AQ derivatives. Most AEs were gastrointestinal (41.6%), central nervous system (18.2%), and dermatological disorders (12.6%). Conclusions. The number of AE reports recorded in the last 10 years is still relatively low. However, given the seriousness of some AEs, that does not represent a guarantee of safety. This study may contribute to enhance public awareness on the risks associated with misuse or abuse of laxatives.

引用

页码：131 / 138

页数：8