Skip to Content

Lacosamide Pregnancy and Breastfeeding Warnings

Lacosamide is also known as: Vimpat

Medically reviewed on April 10, 2018

Lacosamide Pregnancy Warnings

Animal studies have revealed evidence of increased embryofetal mortality, perinatal mortality, growth deficit, and developmental neurotoxicity. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are advised to recommend that pregnant patients taking this drug enroll in the North American Antiepileptic Drug Pregnancy Registry. This can be done by calling 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at http://www.aedpregnancyregistry.org.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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.

Use is not recommended unless clearly needed.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned.

Risk Summary: This drug caused developmental toxicity (e.g., increased embryofetal and perinatal mortality, growth deficit) in animal studies following administration during pregnancy. Developmental neurotoxicity was observed following administration during postnatal development corresponding to the third trimester of human pregnancy. These effects were observed at doses equivalent to standard recommended human doses.

Comments:
-A pregnancy exposure registry is available.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking the drug, the patient should be informed of the potential harm to the fetus.
-This drug interferes with the activity of collapsin response mediator protein-2 (CRMP-2), a protein involved in neuronal differentiation and control of axonal outgrowth. Potential adverse effects on CNS development related to this interference cannot be ruled out.

See references

Lacosamide 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: Unknown
Excreted into animal milk: Yes

Limited information indicates that this drug is excreted into human milk in low doses. No data on use in nursing mothers are available.

See references

References for pregnancy information

  1. "Product Information. Vimpat (lacosamide)." UCB Pharma Inc, Smyrna, GA.
  2. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Vimpat (lacosamide)." UCB Pharma Inc, Smyrna, GA.
  3. 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 -]):

Further information

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

Hide