FDA updates infant thyroid monitoring after ICM exposure for x-rays

English

简体中文 繁體中文 English Filipino हिन्दी Hmong Bahasa Indonesia 日本語 Basa Jawa 한국어 ພາສາລາວ Bahasa Melayu മലയാളം ဗမာစာ سنڌي தமிழ் ไทย Tiếng Việt Afrikaans Shqip العربية አማርኛ Հայերեն Azərbaycan dili Euskara Беларуская мова বাংলা Bosanski Български Català Cebuano Chichewa Corsu Italiano Hrvatski Čeština‎ Dansk Nederlands Esperanto Eesti Suomi Frysk Galego ქართული Ελληνικά ગુજરાતી Kreyol ayisyen Deutsch Français Harshen Hausa Ōlelo Hawaiʻi עִבְרִית Magyar Íslenska Igbo Gaeilge ಕನ್ನಡ Қазақ тілі ភាសាខ្មែរ كوردی‎ Кыргызча Latin Latviešu valoda Lietuvių kalba Lëtzebuergesch Македонски јазик Malagasy Maltese Te Reo Māori मराठी Монгол नेपाली Norsk bokmål پښتو فارسی Polski Português ਪੰਜਾਬੀ Română Русский Samoan Gàidhlig Српски језик Sesotho Shona සිංහල Slovenčina Slovenščina Afsoomaali Español Basa Sunda Kiswahili Svenska Тоҷикӣ తెలుగు Türkçe Українська اردو O‘zbekcha Cymraeg isiXhosa יידיש Yorùbá Zulu

The US Food and Drug Administration (FDA) has updated a safety communication warning about the risk of thyroid dysfunction in infants after imaging procedures.

Under the updated recommendations, health care professionals should perform follow-up thyroid monitoring after newborns (3 weeks old or less) and children (up to 3 years old) receive their iodinated contrast media (ICM) injections for X-rays and other medical imaging procedures. These recommendations are related to ICM given as an injection through an artery or vein.

The Agency updated the new prescription information due to the risk of underactive thyroid or a temporary decrease in thyroid hormone levels.

The update follows the FDA’s recent review of six new published studies evaluating this risk, in addition to five previously published studies that assessed thyroid function from ICM exposure in a range of 10 to 2320 children from birth through 3 years of age.

The rate of underactive thyroid cases reportedly ranges from 1% to 15%. In particular, pre-term neonates were at increased risk, while patients with cardiac conditions were at the highest risk.