Galzin Pregnancy Warnings
This drug should be used during pregnancy only if clearly needed.
US FDA pregnancy category: Not assigned
Comments:
-The possibility of fetal harm appears to be remote but cannot be ruled out.
-Copper toxicosis may develop if anti-copper therapy is stopped during pregnancy.
Animal studies of oral administration of doses up to 6 times the maximum recommended human dose (MRHD) showed no fetal harm or impairment of fertility. Studies during all trimesters of human pregnancy showed no increases in fetal abnormalities.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
See references
