藥物警訊

Captomer and Captomer-250 by Thorne Research: FDA Warning - Potential Health Risks

AUDIENCE: Consumer

ISSUE: FDA is warning consumers not to purchase or to use Thorne Research's Captomer or Captomer-250, marketed as a dietary supplement for heavy metal toxicity and heavy metal chelation therapy. The products list DMSA (meso-2, 3-dimercaptosuccinic acid), as an active ingredient, which is contained in an FDA-approved prescription product indicated for the treatment of lead poisoning in children. FDA advises consumers to avoid all products offered over-the-counter (OTC) for chelation or detoxification. There are no FDA-approved OTC chelation products.

Procedures involving chelation agents carry significant risks and should be performed only under medical supervision.

The company has received several adverse event reports associated with these products. Thorne Research has agreed to voluntarily recall the products. For recall information, contact Thorne Research.

BACKGROUND: FDA-approved chelating agents are available by prescription only and are approved for use in specific indications such as lead poisoning and iron overload.

RECOMMENDATION: Do not purchase or use Captomer or Captomer-250. Avoid all products offered over-the-counter (OTC) for chelation or detoxification.
Read the MedWatch safety alert, including a link to the warning statement, at:http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm401081.htm

FDA發布安全警訊，提醒民眾勿購買或使用Thorne Research生產，用於重金屬中毒及重金屬螯合治療之Captomer或 Captomer-250膳食補充品。此產品之活性成分DMSA （meso-2, 3-dimercaptosuccinic acid），為美國FDA核准用於治療兒童鉛中毒之處方藥品，但目前尚未有任何經FDA核准之非處方螯合劑。FDA建議應避免使用任何市面上供應用來螯合或解毒之產品。螯合劑具有顯著風險，應在醫療人員監督下執行。近來Thorne Research藥廠接獲數件此產品相關之不良反應案例，已同意進行主動回收。

背景：FDA核可之螯合劑僅適用於醫師處方且核准用於如鉛中毒及鐵離子過量等特殊適應症。

建議：請勿購買或使用Captomer或Captomer-250，以及任何市面上用於螯合治療或解毒之非處方藥品。

相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm401081.htm

資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部