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Hemin Pregnancy and Breastfeeding Warnings

Brand names: Panhematin

Medically reviewed by Drugs.com. Last updated on Aug 11, 2023.

Hemin 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

Hemin Breastfeeding Warnings

Safety has not been established.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-The effects in the nursing infant are unknown

See references

See also

References for pregnancy information

  1. Product Information. Panhematin (hemin). Recordati Rare Diseases Inc. 2001;PROD.
  2. Cerner Multum, Inc. UK Summary of Product Characteristics.

References for breastfeeding information

  1. Product Information. Panhematin (hemin). Recordati Rare Diseases Inc. 2001;PROD.
  2. Cerner Multum, Inc. UK Summary of Product Characteristics.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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