Bupivacaine / epinephrine Pregnancy and Breastfeeding Warnings

Brand names: Marcaine HCl with Epinephrine, Sensorcaine with Epinephrine, Sensorcaine-MPF with Epinephrine, Vivacaine

Bupivacaine / epinephrine Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
-According to some authorities: Use is contraindicated in obstetric paracervical block anesthesia.

AU TGA pregnancy category: A
US FDA pregnancy category: Not assigned.

Risk summary: There are inadequate data available on the use of this drug in pregnant patients to inform of a drug-related risk.

Comments:
-Fetal bradycardia and death have occurred when obstetric paracervical block anesthesia was performed.
-Fetal heart rate should be monitored continuously and electronic fetal monitoring is advisable.
-Maternal hypotension can result from regional anesthesia; elevating the patient's legs and positioning her on her left side will help prevent decreases in blood pressure.
-Consider monitoring blood glucose levels in the newborn following use of obstetric regional anesthesia.

Animal studies with bupivacaine produced developmental toxicity when administered subcutaneously at clinically relevant doses. An increase in embryofetal deaths was observed in rabbits at the higher doses when administered subcutaneously. Fetal bradycardia may occur following paracervical nerve block. The addition of epinephrine may potentially decrease uterine blood flow and contractility, leading to a delay in the second stage of labor. There are no controlled data in human pregnancy.

Local anesthetics rapidly cross the placenta and can cause varying degrees of maternal, fetal, and neonatal toxicity. The incidence and degree of toxicity are dependent upon procedure performed, type and amount of drug used, and technique of administration. Adverse reactions in the parturient, fetus, and neonate include alterations of the central nervous system, peripheral vascular tone, and cardiac function. Epidural anesthesia has been reported to prolong the second stage of labor.

It is of utmost importance to avoid aortocaval compression by the gravid uterus during administration of regional block to parturients. The patient must be maintained in the left lateral decubitus position, or a blanket roll or sandbag may be placed beneath the right hip and gravid uterus displaced to the left.

AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.

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.

See references

Bupivacaine / epinephrine 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: Yes (bupivacaine); Data not available (epinephrine)
Excreted into animal milk: Data not available (epinephrine)

Comments: Due to low levels in breast milk and lack of oral absorption, amounts received by the infant are small and is unlikely to cause any adverse effects in breastfed infants.

Local anesthetics administered during labor and delivery with other anesthetics and analgesics have been reported to interfere with breastfeeding, however, this finding is controversial and complex due to many different combinations of drugs, doses, and patient populations studied and various techniques used. In contrast, epidural use of bupivacaine began after clamping of the umbilical cord appears to enhance breastfeeding. Milk levels were measured in 5 women who were given epidural bupivacaine analgesia for vaginal delivery; this drug was undetectable (less than 20 mcg/L) in all samples taken at 2, 8, 24, and 48 hours postpartum. High IV doses of epinephrine may reduce milk production and milk letdown.

See references

Further information

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

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