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Lacosamide Pregnancy and Breastfeeding Warnings

Lacosamide is also known as: Vimpat

Medically reviewed by Drugs.com. Last updated on Nov 16, 2018.

Lacosamide Pregnancy Warnings

Developmental toxicities have been observed in pregnant rats receiving this drug during pregnancy including increased perinatal mortality and decreased body weights. In rats and rabbits administered this drug during the period of organogenesis, no effects on fetal structure were observed however, doses were limited by maternal toxicity and embryofetal death in rats. Administration to rats during the neonatal and juvenile periods of development (generally thought to correspond to late pregnancy in humans in terms of brain development) resulted in decreased brain weights and long-term neurobehavioral changes (altered open field performance, deficits in learning and memory). In vitro data has shown 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. There are no controlled data in human pregnancy.

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: There are no adequate data on the developmental risks associated with use in pregnant women; developmental toxicity (e.g., increased embryofetal and perinatal mortality, growth deficit) has been observed in animal studies.

Comments:
-There are risks related to epilepsy and antiepileptic products; effective antiepileptic therapy should not be interrupted since aggravation of the illness is detrimental to both mother and fetus.
-Pregnancy Registries:
--The North American Antiepileptic Drug (NAAED) visit http://www.aedpregnancyregistry.org or call 1-888-233-2334.
--Australian Pregnancy Register for Women on Antiepileptic Medication with Epilepsy and Allied Conditions, call 1800 069 722

See references

Lacosamide Breastfeeding Warnings

Benefit should outweigh risk

Excreted into human milk: Yes
Excreted into animal milk: Yes

Comments:
-Limited data shows low levels are present in human milk; until more data is available, use during nursing should be accompanied by close monitoring, especially in a newborn or preterm infant.

Reports of women breastfeeding their infants while taking this drug are very limited. A single woman receiving this drug at 100 mg twice a day along with levetiracetam enoxaparin, and labetalol had lacosamide levels of 0.4 mg/L on postpartum day 5. The authors estimated a fully breastfed infant would receive about 1.8% of the maternal weight-adjusted dose. In 3 women who breastfed for 7 to 9 months (extent not specified, although at least 1 women only partially breastfed) no adverse infant development effects were observed. Some manufacturers advise for precautionary measures, breastfeeding should be discontinued during treatment with this drug.

See references

References for pregnancy information

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

References for breastfeeding information

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

Further information

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

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