Assessment of adverse reactions to alpha-lipoic acid containing dietary supplements through spontaneous reporting systems.
|アブストラクト||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.
|投稿者||Gatti, Milo; Ippoliti, Ilaria; Poluzzi, Elisabetta; Antonazzo, Ippazio Cosimo; Moro, Paola Angela; Moretti, Ugo; Menniti-Ippolito, Francesca; Mazzanti, Gabriela; De Ponti, Fabrizio; Raschi, Emanuel|
|ジャーナル名||Clinical nutrition (Edinburgh, Scotland)|
|組織名||Pharmacology Unit, Department of Medical and Surgical Sciences, University of;Bologna, Bologna, Italy.;Centre for Drug Research and Evaluation, National Institute of Health, Rome,;Italy.;Poison Control Center, Niguarda Ca' Grande Hospital, Milan, Italy.;Department of Public Health and Community Medicine, University of Verona, Verona,;Italy. Electronic address: email@example.com.;Department of Physiology and Pharmacology 'Vittorio Erspamer', Sapienza;University of Rome, Rome, Italy.|