Hemin Pregnancy and Breastfeeding Warnings
Brand names: Panhematin
Medically reviewed by Drugs.com. Last updated on Aug 11, 2023.
Hemin Pregnancy Warnings
This drug should be used during pregnancy only if clearly needed.
US FDA pregnancy category: Not assigned
Risk Summary: Insufficient data available on use of this drug in pregnant women to inform a drug-related risk.
Comments:
-This drug should not be administered in severe pre-eclampsia because of the theoretical risk of potentiating the coagulation disorder.
-Porphyria is most severe in early pregnancy and the puerperium and can result in a fatal outcome.
-It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.
-About 50% of women with acute intermittent porphyria experience an acute attack of porphyria in pregnancy and/or the puerperium.
Animal studies have not been conducted. There are no controlled data in human pregnancy.
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.
Hemin Breastfeeding Warnings
Safety has not been established.
-According to some authorities: Caution is recommended
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-The effects in the nursing infant are unknown.
-The developmental and health benefits of breastfeeding should be considered, as well as the mother's clinical need for this drug.
See also
References for pregnancy information
- (2001) "Product Information. Panhematin (hemin)." Recordati Rare Diseases Inc
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- (2023) "Product Information. Normosang (hemin)." Imported (France)
- (2020) "Product Information. Panhematin (hemin)." Recordati Rare Diseases Inc
References for breastfeeding information
- (2001) "Product Information. Panhematin (hemin)." Recordati Rare Diseases Inc
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- (2023) "Product Information. Normosang (hemin)." Imported (France)
- (2020) "Product Information. Panhematin (hemin)." Recordati Rare Diseases Inc
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.