Skip to Content
Living with relapsing MS? Don’t miss these free events >>

Phenobarbital Pregnancy and Breastfeeding Warnings

Phenobarbital is also known as: Luminal, Solfoton

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

References for pregnancy information

  1. "Product Information. Phenobarbital (phenobarbital)." Lilly, Eli and Company, Indianapolis, IN.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Phenobarbital (phenobarbital)." Lilly, Eli and Company, Indianapolis, IN.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.

Hide