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Pregabalin Pregnancy and Breastfeeding Warnings

Pregabalin is also known as: Lyrica, Lyrica CR

Medically reviewed on January 17, 2018

Pregabalin Pregnancy Warnings

This drug should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

AU TGA pregnancy category: B3
US FDA pregnancy category: C

Comment:
-Women of childbearing potential should use reliable contraception during treatment.

Animal studies have revealed increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity including lethality, growth retardation, and both nervous and reproduction system functional impairment. Animal studies have reported that this drug crosses the placenta and have shown an increased risk in male-mediated teratogenicity. There are no controlled data in human pregnancy. There are no controlled data in human pregnancy.

To provide information regarding the effects of in utero exposure to this drug, physicians are advised to recommend that pregnant patients enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website 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 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.

See references

Pregabalin Breastfeeding Warnings

Very limited data indicate that amounts of this drug in breastmilk are low. If therapy is required by the mother of an older infant, it is not a reason to discontinue breastfeeding, but until more data become available, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

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: Yes

Comment:
-The effect on the nursing infant is unknown.

See references

References for pregnancy information

  1. "Product Information. Lyrica (pregabalin)." Pfizer U.S. Pharmaceuticals Group, New York, NY.
  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. 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 -]):
  2. "Product Information. Lyrica (pregabalin)." Pfizer U.S. Pharmaceuticals Group, New York, NY.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

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

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