Dificid Pregnancy Warnings
This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
-According to some authorities: As a precaution, use should be avoided.
AU TGA pregnancy category: B1
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.
Animal studies have failed to reveal evidence of fetal harm. After IV administration to pregnant mice and rabbits during organogenesis, no embryofetal effects were observed at exposures 65-fold or higher for this drug and its main metabolite (OP-1118) than the clinical exposure at the recommended human dose. There are no controlled data in human pregnancy.
AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.
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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Dificid Breastfeeding Warnings
According to some authorities: 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
Comments:
-No data available on the use of this drug during breastfeeding.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
-This drug is poorly absorbed orally; it is not likely to reach the bloodstream of the infant or cause any harmful effects in the nursing infant.
See references
