International archives of allergy and immunology · 2026
Clinical Validation of Pharmacovigilance Algorithms in Suspected Hypersensitivity to Vitamin and Iron Preparations.
СтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Gumusburun Reyhan, Inan Sinem, Akten Hatice Serpil, Demiroglu Gulhan, Kural Ragıp Fatih, Galata Zuleyha, Aytac Hasibe, Bulut Gokten, Camyar Asuman, Ozısık Melih, Demir Meryem, Okan Kasım, Yıldırım Onurcan, Ozeki Yusuf, Aslan Eda, Kırdok Kutay, Ates Umitcan, Ay Ecem, Toksoy Senturk Meryem Irem, Tunakan Dalgıc Ceyda, Mete Gokmen Emine Nihal, Kokuludag Ali, Sin Aytul Zerrin
Аннотация
INTRODUCTION: Vitamin- and iron-containing medicinal preparations are widely perceived as safe; however, hypersensitivity reactions may pose diagnostic challenges. Standardized diagnostic pathways for suspected hypersensitivity are limited. This study aimed to compare pharmacovigilance-based causality assessment tools with allergist-defined clinical outcomes in patients evaluated for suspected hypersensitivity to vitamin- and iron-containing preparations.
METHODS: A retrospective review was performed in 40 patients referred to a tertiary allergy center for suspected adverse reactions to vitamin- or iron-containing medicinal preparations. Demographic characteristics, index reaction features, diagnostic testing results, and clinical outcomes were collected. Causality classifications using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) system and the Naranjo algorithm were compared with allergist-defined final evaluations.
RESULTS: The cohort was predominantly female (97.5%) and atopic. Iron-containing products were most commonly implicated (40%), followed by B complex vitamins (27.5%) and combined formulations (12.5%). Most reactions reflected type B hypersensitivity (67.5% immediate; 10% delayed). Diagnostic testing was feasible in 82.5% of patients, and confirmed hypersensitivity was uncommon (10%), with most reactions classified as probable or nonallergic. In a subgroup analysis restricted to single-agent exposures, delayed or probable allergic reactions were more frequent with vitamin B preparations than iron (p = 0.03), and vitamin B complex products were also among the most frequently contraindicated or withheld pending diagnostic testing. WHO-UMC and Naranjo showed significant correlation (χ2 = 74.7, p < 0.001), with fair categorical agreement (κ = 0.28) and strong rank correlation (ρ = 0.78). Concordance with allergist-defined clinical outcomes was weak (WHO-UMC κ = 0.09; Naranjo κ = 0.18).
CONCLUSION: Immunologically mediated hypersensitivity to vitamin and iron preparations appears uncommon in this tertiary allergy cohort. Pharmacovigilance-based causality assessment tools and allergist-led diagnostic evaluation demonstrate complementary but non-interchangeable roles, highlighting the importance of clinical verification in hypersensitivity reactions.
METHODS: A retrospective review was performed in 40 patients referred to a tertiary allergy center for suspected adverse reactions to vitamin- or iron-containing medicinal preparations. Demographic characteristics, index reaction features, diagnostic testing results, and clinical outcomes were collected. Causality classifications using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) system and the Naranjo algorithm were compared with allergist-defined final evaluations.
RESULTS: The cohort was predominantly female (97.5%) and atopic. Iron-containing products were most commonly implicated (40%), followed by B complex vitamins (27.5%) and combined formulations (12.5%). Most reactions reflected type B hypersensitivity (67.5% immediate; 10% delayed). Diagnostic testing was feasible in 82.5% of patients, and confirmed hypersensitivity was uncommon (10%), with most reactions classified as probable or nonallergic. In a subgroup analysis restricted to single-agent exposures, delayed or probable allergic reactions were more frequent with vitamin B preparations than iron (p = 0.03), and vitamin B complex products were also among the most frequently contraindicated or withheld pending diagnostic testing. WHO-UMC and Naranjo showed significant correlation (χ2 = 74.7, p < 0.001), with fair categorical agreement (κ = 0.28) and strong rank correlation (ρ = 0.78). Concordance with allergist-defined clinical outcomes was weak (WHO-UMC κ = 0.09; Naranjo κ = 0.18).
CONCLUSION: Immunologically mediated hypersensitivity to vitamin and iron preparations appears uncommon in this tertiary allergy cohort. Pharmacovigilance-based causality assessment tools and allergist-led diagnostic evaluation demonstrate complementary but non-interchangeable roles, highlighting the importance of clinical verification in hypersensitivity reactions.