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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). 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. 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. 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. [ABSTRACT FROM AUTHOR]

Background: "Impulse Control Disorders" are behavioral conditions (e.g., gambling, hypersexuality), which are increasingly reported as reactions to dopamine agonists in Parkinson's disease. The Questionnaire for Impulsive-Compulsive Disorders in Parkinson's disease focuses only on 6 behaviors. Nonetheless, impulsivity could affect the entire range of human practices. Because of their heterogeneity and undefined boundaries, it is not clear what conditions should be considered as Impulse Control Disorders. This results in poorly standardized scientific literature and underdiagnosis.Objective: We aimed to create a comprehensive list of possible manifestations of drug-induced Impulse Control Disorders in Parkinson's disease and test it on pharmacosurveillance data.Methods: PubMed was used to identify reviews in English about Impulse Control Disorders in Parkinson's disease. Mentioned conditions were charted and translated to the lexicon of MedDRA, ICD-11, and DSM-5. The relevant MedDRA terms were used to test potential association with dopamine agonists on the FDA Adverse Event Reporting System.Results: 50 reviews published between 2001 and 2020 were identified. 66 conditions were collected as possible Impulse Control Disorders. Pathological gambling, shopping, eating and sexuality, dopamine dysregulation syndrome, hobbyism and punding were the most frequently mentioned, together with leisure activities, body-focused compulsivity, disruptive, impulse control and conduct disorders, and substance abuse. All these conditions were disproportionately reported with dopamine agonists, except for substance abuse.Conclusions: We defined a potential extended list of ICDs, which, along with its conversion to international taxonomies, can support the identification of drug-induced conditions in pharmacovigilance archives, as well as monitoring processes in clinical practice. [ABSTRACT FROM AUTHOR]

Background The anti-hepatitis B immunization campaigns launched in the early 1990s were a major public health breakthrough and targeted various populations (at-risk adults, newborns, adolescents). However, debate is still active about a possible link between this vaccine and central demyelination. This study provides a pooled estimate of this risk based on a comprehensive review and meta-analysis of all available epidemiologic studies. Methods A systematic review was conducted in Medline, Embase, ISI Web of Science and the Cochrane Library from database inception to 10 May 2017. Grey literature was searched and snowballing was also undertaken. Only observational studies including a control group were retained. Primary outcome was multiple sclerosis diagnosed by recognized criteria. Study selection was performed by two independent reviewers with disagreements solved through discussion. This meta-analysis based on crude, adjusted estimates, or risks limited to the 3 months following immunization was performed using a generic inverse variance random-effect model. Heterogeneity was investigated; sensitivity and subgroup analyses were performed when necessary. This study followed the PRISMA statement and the MOOSE reporting guideline (Study protocol registered in PROSPERO: CRD42015020808). Findings Of the 2804 references reviewed, 13 studies with a control group were analysed. None of the pooled risk estimates for either multiple sclerosis or central demyelination following HB immunization reached statistical significance. When considering adjusted risk ratios, the following non-significant figures were obtained: 1.19 (95%CI: 0.93 – 1.52) and 1.25 (95%CI: 0.97 – 1.62), for multiple sclerosis and central demyelination, respectively. Conclusions No evidence of an association between hepatitis B vaccination and central demyelination was found. [ABSTRACT FROM AUTHOR]