藥物警訊

Iodine-containing Contrast Agents for Medical Imaging: Drug Safety Communication - Rare Cases of Underactive Thyroid in Infants

AUDIENCE: Radiology, Endocrinology, Patient

ISSUE: FDA is advising that rare cases of underactive thyroid have been reported in infants following the use of contrast media containing iodine, also called “contrast dye,” for X-rays and other medical imaging procedures. In all of the reported cases, the infants were either premature or had other serious underlying medical conditions. Available evidence leads FDA to believe that this rare occurrence is usually temporary and resolves without treatment or any lasting effects. See the Drug Safety Communication for a data summary and a list of approved Approved Iodinated Contrast Media Products.

FDA approved changes to the labels of all iodinated contrast media (ICM) products to include information about these cases. No changes to current prescribing, administration, or monitoring practices are recommended. FDA will continue to evaluate this issue and will update the public when there is additional information. Manufacturers of ICM products have been required to conduct a study to investigate this safety issue further.

BACKGROUND: Iodinated contrast media are drugs containing iodine that are given to patients to enhance the ability to see blood vessels and organs on medical images such as X-rays or computed tomography (CT) scans. These images provide greater detail when necessary to help health care professionals diagnose potential problems.

RECOMMENDATION: Parents and caregivers should contact their baby's health care professional for additional information or if they have questions or concerns about their baby receiving an ICM product. Infants typically do not show any visible signs of underactive thyroid. Health care professionals should continue to follow the label recommendations for ICM products. They should continue to use their clinical judgment to determine if testing for underactive thyroid is necessary.

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

美國FDA接獲嬰兒使用含碘顯影劑後出現甲狀腺功能低下之案例報告。通報案例中之嬰兒皆為早產兒或伴有其他嚴重潛在疾病。美國FDA認為依據現有資料，此罕見的現象通常為暫時性且可不經治療下自行改善，也不具有長期性影響。

進行X光或電腦斷層檢查前給予含碘顯影劑，主要是為了使病人的血管及器官在影像中更清楚呈現，以提供醫療人員更多資訊及協助診斷相關潛在性疾病。

美國FDA已進行所有含碘顯影劑的仿單更新，新增此罕見案例之相關資訊。其餘開方、給藥或監測建議皆無修改。美國FDA將持續評估，並要求含碘顯影劑廠商應進行相關安全性研究計畫。

嬰兒通常不會表現出甲狀腺功能低下之明顯現象，若家屬對於嬰兒使用含碘顯影劑有任何疑問，可向醫療人員諮詢或聯繫。醫療人員應依循此類藥品之仿單建議，且應留意病人臨床情況，判斷是否需進行進一步甲狀腺功能檢查。

相關訊息與連結請參考FDA網址：

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

[Posted 11/17/2015]

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