Assessment of adverse reactions to α-lipoic acid containing dietary supplements through spontaneous reporting systems.
Clin Nutr
; 40(3): 1176-1185, 2021 03.
Article
em En
| MEDLINE
| ID: mdl-32778460
ABSTRACT
BACKGROUND & AIMS:
Alpha-lipoic acid (ALA)-containing dietary supplements are widely used in clinical practice, although their safety assessment is under-investigated. We characterize the safety profile of ALA-containing products by analysing spontaneous reports of suspected adverse reactions (ARs).METHODS:
Suspected ARs to ALA-containing products were extracted from the Italian Phytovigilance System (IPS), and scrutinized in terms of seriousness and causality (through WHO UMC system), with a specific focus on important (IMEs) and designated medical events (DMEs). To characterize the reporting profile from an international perspective, the WHO-VigiBase was also queried.RESULTS:
From March 2002 to February 2020, out of 2147 total reports, 116 reports concerning 212 ARs to ALA-containing products were collected. Women were involved in 68.1% of cases. Skin (44.9%) and gastrointestinal disorders (10.8%) were the most frequently represented ARs. Causality assessment resulted as definite (15), probable (35), possible (24), unlikely (5), and unclassifiable (37). In 70% of cases, events occurred within 30 days of ALA use. Forty-five reports were serious (38.8%), being insulin autoimmune syndrome the most frequently reported (N = 10). IMEs were recorded in 20 cases, including four DMEs (3 angioedema and one anaphylactic shock). Similar distribution emerged from the 5641 reports in the WHO-VigiBase.CONCLUSIONS:
The remarkable reporting of unpredictable skin, immune and hepatic ARs, coupled with seriousness, strong causality and early onset, calls for a) careful risk-benefit assessment of ALA-containing products by regulators; b) awareness and monitoring by clinicians and c) continuous vigilance of their safety profile through valuable spontaneous reporting systems such as IPS.Palavras-chave
Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Ácido Tióctico
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Sistemas de Notificação de Reações Adversas a Medicamentos
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Toxidermias
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Suplementos Nutricionais
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Gastroenteropatias
Idioma:
En
Ano de publicação:
2021
Tipo de documento:
Article