Acetaminophen / pseudoephedrine Pregnancy and Breastfeeding Warnings

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Medically reviewed by Drugs.com. Last updated on Aug 16, 2023.

Acetaminophen / pseudoephedrine Pregnancy Warnings

Animal studies have not been performed with the combination product. There are no controlled data in human pregnancy.

Acetaminophen: Routinely used during all stages of pregnancy, it appears safe for short-term use. This drug crosses the placenta.

Pseudoephedrine: Animal studies at up to 50 times the maximum human daily dose did not show teratogenicity. A monitoring study of 50, 282 mother/child pairs (3082 first trimester sympathomimetic drug exposures, 9719 any time pregnancy exposures) suggested a link to categories of minor malformations (non-life-threatening, no major cosmetic defects) including inguinal hernia and clubfoot. Pseudoephedrine may be associated with gastroschisis, but this may also be caused by maternal health factors. First trimester oral decongestant exposure or maternal smoking may increase the risk of gastroschisis, small intestinal atresia (SIA), and hemifacial microsomia.


AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

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.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned

Comments:
-Acetaminophen is commonly used during pregnancy and has been assumed safe; recent data questions the safety, especially with routine use or varying genetics.
-Routine use of acetaminophen during pregnancy is not advised.
-Pseudoephedrine use during the first trimester may be associated with gastroschisis and small intestinal atresia (SIA); data is limited and unconfirmed, risk appears to be low (only identifiable by case-control studies), and may only occur in combination products, but avoidance during the first trimester is nonetheless recommended.

See references

Acetaminophen / pseudoephedrine Breastfeeding Warnings

Use is not recommended unless benefit to mother outweighs risk to the infant.

Excreted into human milk: Yes (acetaminophen, pseudoephedrine)

Comments:
-The small amounts of pseudoephedrine (about 4.3 to 5.5% of maternal dose) may cause occasional irritability.
-A single pseudoephedrine dose acutely decreases milk production (average 24%); repeated use interferes with lactation.
-Do not use pseudoephedrine in patients with insufficient milk production or in those just establishing lactation.
-The amount of acetaminophen in breast milk is much less than typical infant doses.
-One study calculated that infants receive about 0.14% of the parental absolute dose, or about 2% of the maternal weight-adjusted dosage.

See references

Further information

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