Skip to Content

Valproic acid Pregnancy and Breastfeeding Warnings

Valproic acid is also known as: Depacon, Depakene, Stavzor, Valproate Sodium

Valproic acid Pregnancy Warnings

-Animal studies have revealed evidence of embryolethality, teratogenicity (i.e., neural tube defects, skeletal, cardiac, urogenital defects), behavioral abnormalities, intrauterine growth retardation, and brain histopathological changes. -The rate of congenital malformations among babies born to epileptic mothers who used this drug during pregnancy has been shown to be about 4 times higher than the rate among babies born to epileptic mothers who used other anti-seizure monotherapies. -Studies have shown that children exposed to this drug in utero have lower IQ scores than children exposed to either another antiepileptic drug or to no antiepileptic drugs. -Exposure to this drug during pregnancy may increase the risk of autism spectrum disorders. -Hepatic failures (sometimes fatal) in mothers and infants have been reported following use of this drug during pregnancy. -In utero exposure has been associated with neonatal hemorrhagic syndrome due to hypofibrinogenemia. Afibrinogenemia, including fatalities, has also been reported. Neonatal platelet counts, plasma fibrinogen levels, and coagulation status should be monitored. -Withdrawal syndrome (such as agitation, irritability, hyperexcitability, jitteriness, hyperkinesia, tonicity disorders, tremor, convulsions and feeding disorders) may occur in neonates. -Cases of hypoglycemia have been reported in neonates, whose mothers have taken this drug during the third trimester of pregnancy. -Cases of hypothyroidism have been reported in neonates whose mothers have taken this drug during pregnancy. To provide information regarding the effects of in utero exposure to this drug, physicians should encourage pregnant patients to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling toll free 1-888 233 2334, and must be done by the patients themselves. Information on the registry can be found at the website 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.

AU: Contraindicated UK, US: This drug should be used during pregnancy only if clearly needed and the benefit outweighs the risk. AU TGA pregnancy category: D US FDA pregnancy category: D (for epilepsy) Comments: -This drug can harm a developing fetus. -Adequate methods of contraception should be used. -This drug should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition; generally, the benefit of preventing seizures is considered to outweigh the potential risk of fetal harm due to antiepileptic medications. -If this drug is used during pregnancy, it should be administered as monotherapy (if possible) in divided doses, using prolonged-release preparations (to avoid high peak concentrations) and at the lowest effective daily dose, with close monitoring of the patient's clotting parameters. -Women who are planning a pregnancy should be counseled regarding the relative risks and benefits of using this drug during pregnancy, and alternative therapeutic options should be considered for these patients. -Women should be offered routine ultrasound and amniocenteses for prenatal diagnosis of abnormalities. -Supplementation with folic acid 5 mg daily should be recommended prior to conception and during the first trimester of pregnancy to decrease the risk for congenital neural tube defects. -Therapy should not be abruptly discontinued in pregnancy, as this may precipitate status epilepticus, leading to maternal and fetal hypoxia and threat to life. -A pregnancy exposure registry is available; this registry has reported a major malformation rate of 9% to 11% in the offspring of women taking this drug as monotherapy during pregnancy.

See references

Valproic acid Breastfeeding Warnings

No definite adverse reactions to this drug during breastfeeding have been reported. Theoretically, breastfed infants are at risk for hepatotoxicity. Breastfeeding during monotherapy does not appear to adversely affect infant growth or development. Combination therapy with sedating anticonvulsants or psychotropics may result in infant sedation or withdrawal reactions.

AU, UK: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. US: Caution is recommended. Excreted into human milk: Yes Comments: -Breastfed infants may be at a higher risk for hepatotoxicity, so they should be monitored for jaundice and other signs of liver damage during maternal therapy. -Some experts recommend monitoring infant serum levels of this drug, platelets, and liver enzymes during therapy.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Depacon (valproic acid)." Abbott Pharmaceutical, Abbott Park, IL.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Product Information. Depakene (valproic acid)." Abbott Pharmaceutical, Abbott Park, IL.

References for breastfeeding information

  1. "Product Information. Depacon (valproic acid)." Abbott Pharmaceutical, Abbott Park, IL.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Depakene (valproic acid)." Abbott Pharmaceutical, Abbott Park, IL.
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and 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.