The chapter provides some summary data on commonly used drugs and substances that may be taken by the mother during pregnancy and breast-feeding. Regardless of the designated risk category or presumed safety, no drug or substance should be used during pregnancy or breast-feeding unless it is clearly needed and the potential benefits clearly outweigh the risks.
Table 133–1 lists the generic medication name and in parentheses the Food and Drug Administration (FDA) fetal risk category as of the fall of 2008 (see later). Reported pregnancy-adverse events and comments are presented based on the available reports in the literature. Next, breast-feeding compatibility is noted. At the present time there is no formally FDA-sanctioned breast-feeding category, and the system used here is discussed later. Lastly, any reported effects on lactation or on infant effects based on breast milk consumption are noted. The editorial board has made an attempt to summarize the data based on the best information available for an individual agent where sources disagree. These data are subject to change as new information becomes available. The reader is advised to consult the FDA and manufacturer's web site for the latest information concerning risks of these medications.
Table 133–1. Effects of Drugs and Substances in Pregnancy and Breast-Feeding |Favorite Table|Download (.pdf)
Table 133–1. Effects of Drugs and Substances in Pregnancy and Breast-Feeding
Drug (FDA Fetal Risk Category)
Pregnancy-Adverse Events and Comments
Effect on Lactation and Adverse Effects on Infant
Acebutolol (B; D if 2nd and 3rd trimester)
IUGR. Bradycardia and hypotension in infant exposed near term. Can cause transient hypoglycemia.
Excreted into breast milk. May cause bradycardia and hypotension.
Safe for short-term use. In long-term and overdose: fetal and neonatal death with hepatorenal toxicity.
Excreted in breast milk. AAP:compatible.
Not associated with malformations.
Excreted in breast milk. AAP: compatible.
Human studies: no increase in congenital malformations. ACOG recommends insulin for gestational diabetes. Causes symptomatic hypoglycemia and seizures in newborn. Monitor infant's glucose after birth.
No studies; effects unknown. Risk of hypoglycemia.
No adverse effects seen.
No adverse effects reported. High IV doses: potential fetal toxicity.
No studies. Drug unlikely excreted into breast milk.
Fetal tachycardia, hypoglycemia, risk of polydactyly, transient fetal hyperglycemia, and atrial flutter, and decreased incidence of RDS.
No studies. Probably compatible.
Alfentanil (C; D if prolonged or high doses near term)
Risk in 3rd trimester. No adverse effects. Respiratory depression.
Excreted into breast milk. Significance of amount unknown.
Drug excreted in breast milk. AAP: compatible.
Neonatal withdrawal may occur.
Excreted in breast milk. Risk of withdrawal, lethargy, weight loss, and adverse effects on neurodevelopment. AAP: effect unknown but of concern.
Risk of hemorrhage in mother.
Unknown excretion. Risk to infant minimal.
Amikacin (C; D per manufacturer)
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