IODINATED GLYCEROL

Fetal Risk Summary

Iodinated glycerol is a stable complex containing 50% organically bound iodine (see Potassium Iodide). In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 1,453 newborns had been exposed to iodinated glycerol during the 1st trimester (F. Rosa, personal communication, FDA, 1993). A total of 65 (4.5%) major birth defects were observed (61 expected). Specific data were available for six defect categories, including (observed/expected) 11/15 cardiovascular defects, 0/2 oral clefts, 1/1 spina bifida, 8/4 polydactyly, 1/2 limb reduction defects, and 1/3 hypospadias. An additional 1,338 newborns were exposed to the general class of expectorants during the 1st trimester with 63 (4.7%) major birth defects observed (57 expected). Specific malformations were (observed/expected) 9/13 cardiovascular defects, 0/2 oral clefts, 1/1 spina bifida, 7/4 polydactyly, 1/2 limb reduction defects, and 3/3 hypospadias. These data do not support an association between 1st trimester use of either iodinated glycerol or the general class of expectorants and congenital defects.

Breast Feeding Summary

See Potassium Iodide.