In March 2022, the FDA released a Drug Safety Communication (DSC) outlining the risks of hyperthyroidism in infant patients who received injectable iodinated contrast media that took many in the pediatric medical community by surprise due to the level of concern and strength of recommendation outlined in the DSC. In response to the communication, SCAI representatives from the Congenital Heart Disease (CHD) Council took several steps to both get more clarity on the FDA’s intent in releasing the DSC as well as to start a dialogue with the FDA. In June 2022, CHD representatives attended a meeting with the FDA, hosted by the Pediatric Endocrine Society, that outlined why the science cited in the DSC was not sufficient to warrant such a strong recommendation. Building off that meeting, in August 2022, SCAI representatives hosted their own meeting with FDA where the group outlined the reasons why the current DSC recommendation is untenable. Finally, as follow-up to the August 2022 meeting, SCAI’s CHD Council sent the FDA a letter outlining their concerns and requesting minor revisions to the DSC and is currently awaiting the FDA’s response. The CHD Council is also actively working with other associations to compose a multi-society position statement that will be released imminently.
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