Safety has not been established during pregnancy; use should be avoided during the third trimester of pregnancy.

US FDA pregnancy category: Not assigned.

Risk Summary: No data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Avoid use during third trimester as it may cause premature closure of the ductus arteriosus, increase the incidence of post-term pregnancy, increase duration of pregnancy, and cause excessive blood loss during labor and delivery.
-Not recommended in women attempting to conceive as may impair female fertility.

Animal studies with aspirin have revealed evidence of adverse developmental effects at higher doses. Use of aspirin during the third trimester may increase the risk of neonatal complications, including necrotizing enterocolitis, patent ductus arteriosus, intracranial hemorrhage in premature infants, low birth weight, stillbirth, and neonatal death. Animal studies with omeprazole have revealed evidence of changes in bone morphology and dose-dependent embryolethality at higher doses. There are no controlled data in human pregnancy.

NSAIDs may impair female fertility; withdrawal of this drug should be considered in women with difficulties conceiving or who are undergoing investigation of infertility.

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.

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Limited data from clinical lactation studies describe the presence of aspirin in human milk at relative infant doses of 2.5% to 10.8% of the maternal weight-adjusted dose. Case reports of breastfed infants whose mothers were exposed to aspirin during lactation revealed evidence of adverse reactions including metabolic acidosis, thrombocytopenia, and hemolysis. Limited data from a separate case report describes the presence of omeprazole in human milk at a relative infant dose of 0.9% of the maternal weight-adjusted dose.

Use is not recommended.

Excreted into human milk: Yes (aspirin, omeprazole)

Comments:
-The direct use of aspirin in infants and children is associated with Reye's syndrome, even at low plasma levels.
-Use of this drug during breastfeeding is not recommended due to the potential for adverse reactions in nursing infants including metabolic acidosis, thrombocytopenia, hemolysis, or Reye's syndrome.

See references