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Iodinated Contrast Agents and Risk of Hypothyroidism in Young Children in the United States

Jick, Susan S., DSc*; Hedderson, Monique, PhD; Xu, Fei, MS; Cheng, Yingkai, MD, PhD; Palkowitsch, Petra, MD§; Michel, Alexander, MD, MSc

doi: 10.1097/RLI.0000000000000541
Original Articles

Background Although it is generally acknowledged that exposure to iodine contrast agents can interfere with thyroid function, little is known about the incidence of iodine-induced hypothyroidism in young children (younger than the age of 4 years).

Study Objectives This was a retrospective cohort study to estimate the incidence rate of detected hypothyroidism in a US-based general population of pediatric patients exposed to an iodinated contrast agent.

Setting The study was conducted in Kaiser Permanente Northern California, an integrated health care delivery system.

Study Population This study included 2320 pediatric patients younger than 4 years of age who had a diagnostic procedure with an iodinated contrast agent during years 2008 to 2016.

Results Among 2320 young children who met our study criteria, we identified 34 who met the initial criteria to be a case of hypothyroidism. The incidence density ratio for all hypothyroidism in iodine contrast agent–exposed patients was 1.33 per 1000 person months (95% confidence interval, 0.9–1.8). Most cases appeared to have subclinical hypothyroidism. The rate was higher for the probably iodine-induced cases (0.90 per 1000 person months) compared with cases with a possible alternate etiology (0.43 per 1000 person months), for males compared with females, and among children who had a heart catheterization compared with those with a computed tomography scan. It was also highest among the youngest children (younger than 3 months old), and decreased with increasing age.

Discussion Our finding of hypothyroidism in young children exposed to iodine contrast agents (1.33 per 1000 person months [95% confidence interval, 0.9–1.8]) is broadly consistent with the sparse literature on this outcome.

From the *Boston Collaborative Drug Surveillance Program, Boston University School of Public Health, Boston, MA;

Division of Research, Kaiser Permanente Northern California, Oakland, CA;

Pharmacovigilance, Bayer US, Whippany, NJ;

§Medical and Clinical Affairs Radiology, Bayer AG, Berlin, Germany; and

Epidemiology, Division of Pharmaceuticals, Bayer Consumer Care AG, Basel, Switzerland.

Received for publication September 11, 2018; and accepted for publication, after revision, November 15, 2018.

Conflicts of interest and sources of funding: This study was funded by Bayer AG Germany. Y.C., P.P., and A.M. are employees of Bayer AG.

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Correspondence to: Susan S. Jick, DSc, Boston Collaborative Drug Surveillance Program, Boston University School of Public Health, 11 Muzzey St, Lexington, MA 02421. E-mail:

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