Amobarbital Pregnancy and Breastfeeding Warnings

Amobarbital Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned.

Risk Summary: Barbiturates can cause fetal damage when given during pregnancy.

Comments:
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-If used during labor, the newborn should be monitored for respiratory depression and resuscitation equipment should be available.
-If used during pregnancy, the newborn should be monitored for acute withdrawal syndrome symptoms for up to 14 days after birth.

Human studies suggest that barbiturate use is connected to a higher than expected incidence of fetal abnormalities. Fetal blood levels approached maternal levels with parenteral administration. This drug crosses the placental barrier and distributes in fetal tissues, including the placenta, liver, and brain. Use during the first and third trimesters may be associated with an increased risk of teratogenicity and withdrawal symptoms in the newborn, respectively. This drug decreases the force and frequency of uterine contractions when used at full anesthetic doses.

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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