Interferon beta-1b Pregnancy and Breastfeeding Warnings

Brand names: Betaseron, Extavia

Medically reviewed by Drugs.com. Last updated on Sep 30, 2024.

Interferon beta-1b Pregnancy Warnings

Safety has not been established during pregnancy.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned

Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk

Animal studies have revealed evidence of embryolethality, There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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.

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Interferon beta-1b Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comment:
-The effects in the nursing infant are unknown.

-The levels of this drug in breastmilk are minuscule. Because this drug is poorly absorbed orally, it is not likely to reach the bloodstream of the infant. A small number of nursing mothers receiving this drug while partially breastfeeding their infants and one woman who exclusively breastfed her infant reported no adverse effects.

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Further information

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

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