Phenobarbital Pregnancy and Breastfeeding Warnings

Brand names: Luminal, Sezaby, Solfoton

Medically reviewed by Drugs.com. Last updated on Mar 8, 2024.

Phenobarbital Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: D
US FDA pregnancy category: D/B (manufacturer dependent)

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.
-Supplementation with folic acid is recommended before conception and during pregnancy; vitamin K supplementation in women and neonates may be necessary.
-If used during pregnancy, monitor the newborn for acute withdrawal syndrome symptoms for up to 14 days after birth.
-If used during labor, monitor the newborn for respiratory depression and have resuscitation equipment available.

Human studies suggest that this drug is connected to 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.

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 D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

See references

Phenobarbital Breastfeeding Warnings

Not recommended.

Excreted into human milk: Yes

Comments:
-Breastfed infants should be monitored for sedation, weight gain, and developmental milestones, especially in younger infants who are exclusively breastfed or during concomitant use with psychotropic drug combinations.
-If toxicity is a concern, infant serum concentration of this drug should be obtained.

Excretion of this drug into breastmilk is highly variable. Breastfed infants showed increased sedation and suckling difficulties compared to infants that were not exposed to this drug. Reports of infantile spasms and withdrawal symptoms in infants occurred after abrupt discontinuation. Since this drug is excreted in breastmilk, methemoglobinemia is another potential risk.

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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