105年度健康食品及膠囊錠狀食品非預期反應案件分析   全文下載

Analysis of Case Reports for Unexpected Reactions of Health Food and Food in Capsule or Tablet form in 2016

105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19件食品非預期反應通報案件，通報者以民眾為主，通報縣市以台北市居多，食用者女性略多男性，年齡層以51-60歲之級距最多，產品取得來源以直銷通路居多，案件約有四成是同時食用二項以上產品，約有三成同時併用藥品。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。105年於諮議小組會議進行討論之通報案件共計24件，行政處置列為「錄案參辦」計20件，「監視」4件。針對8案證據性屬於「可能與產品相關」以上之案件，其嚴重程度「全身症狀」及「局部症狀」各占一半；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。

In 2016, the Taiwan Food and Drug Administration (TFDA) received 19 case reports for unexpected reactions of health food and food in capsule or tablet forms (URHFCT), mainly from consumers. Most URHFCT cases were reported from Taipei city and for the female population. The largest age group was 51- 60 years and the products were mostly from direct sale. 40% of the cases involved the consumption of more than two products and 30% of the cases involved the concurrent use of medications. The 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 24 case reports discussed in the consultation committee of URHFCT in 2016, 20 reports were archived, while 4 reports were placed under monitoring. Eight cases assigned causality categories of “certain”, “probable” or “possible”, half were associated with systemic symptoms, while the other half were associated with local symptoms. Skin and subcutaneous tissue disorder was the most frequently reported symptoms.