Panhematin Pregnancy Warnings
Animal studies have not been conducted with this drug. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.
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.
This drug should be used during pregnancy only if the benefit outweighs the risk.
US FDA pregnancy category: Not assigned.
Risk Summary: About 50% of the women with acute intermittent porphyria experience an acute attack of porphyria in pregnancy and/or the puerperium. It is most severe in early pregnancy and the puerperium and can result in fatal outcome. This drug should not be administered in severe pre-eclampsia because of a theoretical risk of potentiation of the coagulation disorder.
Comments:
-The effects in the developing fetus are unknown.
See references
