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Lithium Pregnancy and Breastfeeding Warnings

Lithium is also known as: Eskalith, Eskalith-CR, Lithium Carbonate ER, Lithobid, Lithonate, Lithotabs

Lithium Pregnancy Warnings

Animal studies have reported evidence of interference with fertility, gestation, and fetal development. Cardiac and other anomalies, including Ebstein's anomaly, have been reported in humans. Newborns exposed throughout pregnancy may have signs/symptoms of lithium toxicity, but they were usually self-limiting and resolved within 1 to 2 weeks. In vitro studies in male animals have reported evidence of metabolism of the testis; human males have reported evidence of spermatozoa metabolism. AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug is only recommended for use during pregnancy when there are no alternatives and the benefit outweighs the risk. AU TGA pregnancy category: D US FDA pregnancy category: D Comments: -Use of adequate methods of contraception should be encouraged. -If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus. -If used during pregnancy, serum lithium levels should be closely monitored and prenatal diagnosis of malformations should be conducted. Use should be discontinued shortly before delivery and restarted a few days postpartum. -After birth, the newborn should be monitored for signs/symptoms of lithium toxicity, including thyroid function.

See references

Lithium Breastfeeding Warnings

Excretion of this drug into breastmilk is highly variable. There have been reports of breastfed infants who have shown signs/symptoms associated with lithium toxicity (e.g., hypertonia, hypothermia, cyanosis, and ECG changes); this may occur more frequently in infants with elimination impairments (e.g., dehydration) or in newborn/premature infants.

Use is contraindicated (AU, UK) Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother (US) Excreted into human milk: Yes Comments: -Bottle feeding is recommended due to the risk of lithium toxicity. -If breastfeeding is continued, monitoring of infant serum lithium, serum creatinine, blood urea nitrogen, and thyroid stimulating hormone levels are recommended.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Lithobid (lithium)." Ciba Pharmaceuticals, Summit, NJ.
  4. "Product Information. Eskalith (lithium)." SmithKline Beecham, Philadelphia, PA.

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Lithobid (lithium)." Ciba Pharmaceuticals, Summit, NJ.
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. "Product Information. Eskalith (lithium)." SmithKline Beecham, Philadelphia, PA.

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