106年健康食品及膠囊錠狀食品非預期反應案件分析

106年食品藥物管理署「全國健康食品及膠囊錠狀食品非預期反應通報系統」共接獲15件食品非預期反應通報案件，通報者以民眾為主，通報縣市以台北市和新北市居多，食用者女性男性無差別，年齡層以21-30歲之級距最多，產品取得來源以網路購物和直銷通路居多。通報案件依收案之標準作業流程建立檔案，蒐集個案與產品相關資料，由受託機構財團法人藥害救濟基金會進行初評，再於「健康食品及膠囊錠狀食品非預期反應諮議小組」會議討論。106年於諮議小組會議處理之通報案件共計15件，其中11件評估案行政處置列為「錄案參辦」計4件，「監視」7件。針對9案證據性屬於「可能與產品相關」以上之案件，其中以5件為嚴重程度「全身症狀」為主、其次為「局部症狀」為3件、1件為「住院治療」；分析其非預期反應症狀之器官系統分類，以「皮膚及皮下組織類」最多。

關鍵字

健康食品；膠囊錠狀食品；非預期反應

並列摘要

In 2017, the Taiwan Food and Drug Administration (TFDA) received 15 case reports for unexpected reactions of health food and food in capsule or tablet forms (URHFCT), mainly from consumers. Most URHFCT cases were reported in Taipei city and New Taipei city. There is no difference between male and female population. The largest age group was of 21 - 30 years and the products were mostly from online shopping and direct sale. The standard operation procedures for reporting of URHFCT involves gathering information about the case and products, initial evaluation by the Taiwan Drug Relief Foundation, and further discussion in the consultation committee of URHFCT. Among 15 case reports, 11 case reports were discussed in the consultation committee of URHFCT in 2017; 4 reports were archived while 7 reports were placed under monitoring. Within the 9 cases assigned with causality categories of ＂certain＂, ＂probable＂ or ＂possible,＂ 5 cases were associated with systemic symptoms, while 3 cases were associated with local symptoms and 1 case were hospitalization. Skin and subcutaneous tissue disorder was the most frequently reported symptoms.

並列關鍵字

health food ； food in capsule and tablet forms ； unexpected reactions

國際替代計量

106年健康食品及膠囊錠狀食品非預期反應案件分析

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