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Pregabalin Pregnancy and Breastfeeding Warnings

Pregabalin is also known as: Lyrica, Lyrica CR

Medically reviewed by Drugs.com. Last updated on Jun 12, 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: Not assigned

Risk Summary: There are no adequate and well-controlled studies in pregnant women; animal reproduction studies have shown increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity.

Comment:
-Patients should be advised of the potential risk to a fetus.
-Women of childbearing potential should be encouraged to use reliable contraception during treatment.
-Physicians should encourage pregnant patients to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry; toll free 1-888-233-2334 or http://www.aedpregnancyregistry.org/

Increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity including skeletal malformations, retarded ossification, and decreased fetal body weight have been observed in rat and rabbit offspring receiving this drug at 18 times or greater the maximum recommended dose during organogenesis. Lethality, growth retardation, and nervous and reproductive system functional impairment have been observed in rat offspring receiving this drug during gestation and lactation. Rat offspring tested as adults, showed neurobehavioral abnormalities (decreased auditory startle responding). 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 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.

See references

Pregabalin Breastfeeding Warnings

Limited data have shown the estimated average daily infant dose expected from breast milk is about 7% of the maternal weight adjusted dose.

An unexpectedly high incidence of hemangiosarcoma was observed in standard preclinical in vivo lifetime carcinogenicity studies in 2 different strains of mice. The clinical significance of this finding is unknown.

Benefit should outweigh risk

Excreted into human milk: Yes

Comment:
-The manufacturer recommends against breastfeeding as animal studies have shown a potential risk of tumorgenicity.
-Some authorities believe that discontinuing breastfeeding in an older infant may not be needed because pregabalin levels are low in breast milk.

See references

References for pregnancy information

  1. "Product Information. Lyrica (pregabalin)." Pfizer U.S. Pharmaceuticals Group, New York, NY.
  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. 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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