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Quetiapine Pregnancy and Breastfeeding Warnings

Quetiapine is also known as: Seroquel, Seroquel XR

Medically reviewed on Feb 28, 2017

Quetiapine Pregnancy Warnings

This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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

Comments:
-Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk of experiencing extrapyramidal neurological disturbances and/or withdrawal symptoms following delivery.
-Patients should be advised to notify their physician if they are pregnant or plan to become pregnant during treatment.

Animal studies have revealed evidence of embryo-fetal toxicity. Limited published human data have reported no major malformations associated with use during pregnancy. There are no controlled data in human pregnancy. Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization. This drug is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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

Quetiapine Breastfeeding Warnings

Based on milk samples from a mother who received quetiapine 200 mg daily throughout pregnancy and postpartum, it is estimated that an exclusively breastfed infant would receive 0.09% to 0.43% of a weight-adjusted maternal dose. Limited long-term follow-up of infants exposed to this drug during breastfeeding have shown generally normal development. However, due to the potential for serious adverse reactions in nursing infants and a lack of robust data, a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Use is not recommended; 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

Comments: If this drug is used, monitor infants for drowsiness and developmental milestones.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Seroquel (quetiapine)." Zeneca Pharmaceuticals, Wilmington, DE.
  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. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Seroquel (quetiapine)." Zeneca Pharmaceuticals, Wilmington, DE.
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." 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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