A search through the agency’s adverse event reporting system (FAERS) database revealed 10 cases of underactive thyroid reported between 1969 and early 2012 in infants younger than 4 months who received iodinated contrast media (ICM) products. But FAERS only includes reports submitted to the FDA, “so there may be additional cases about which we are unaware,” the agency said in its safety notice.
All the infants who received the agents “were either premature or had other serious underlying medical conditions,” regulators said in the notice, and all the babies were diagnosed with underactive thyroids within a month of receiving ICM products. Several infants were also given a topical iodine product that could have contributed to their underactive thyroids. The product is no longer recommended for young babies.
Still, underactive thyroids in infants taking ICMs is a “rare occurrence” that is “usually temporary and resolves without treatment or any lasting effects,” the FDA said in its safety notice. The Agency is requiring that labels of all ICM products include information about the cases, but is not recommending any changes to prescribing, administration or monitoring. Regulators are also requiring that ICM manufacturers conduct studies to further investigate the issue. “We will continue to evaluate this safety issue and will update the public when additional information is available,” the FDA said in its safety notice. “The goals of the study that we are requiring the manufacturers to conduct are to determine how often underactive thyroid occurs with ICM use, how long this temporary condition lasts, and if treatment is needed.”
In the meantime, healthcare professionals should continue to follow the label recommendations for ICM products, the Agency said in its alert, and “use their clinical judgment to determine if testing for underactive thyroid is necessary.” The FDA is also recommending that parents and caregivers contact a baby’s doctor for additional information if they have questions or concerns about ICMs. And healthcare professionals, parents and caregivers can also report side effects involving ICMs to the FDA through its MedWatch program, the Agency said.
REFERENCE: Fierce Medical Devices; 18 NOV 2015; Emily Wasserman