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Lacosamide Pregnancy and Breastfeeding Warnings

Lacosamide is also known as: Vimpat

Lacosamide Pregnancy Warnings

Animal studies have revealed evidence of increased embryofetal mortality, perinatal mortality, and growth deficit. 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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Pregnancy Registries: 1) UCB, Inc. has established the UCB AED Pregnancy Registry to advance scientific knowledge about safety and outcomes in pregnant women being treated with this drug. To ensure broad program access and reach, either a healthcare provider or the patient can initiate enrolment in the UCB AED Pregnancy Registry by calling 1-888-537-7734. 2) 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.

This drug should be used during pregnancy only if the benefit outweighs the risk. AU TGA pregnancy category: B3 US FDA pregnancy category: C

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. No long-term 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. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." 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.

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