Pivmecillinam Pregnancy and Breastfeeding Warnings

Brand names: Pivya

Medically reviewed by Drugs.com. Last updated on May 20, 2025.

Pivmecillinam Pregnancy Warnings

According to some authorities: Use should be avoided.

US FDA pregnancy category: Not assigned

Risk summary: There are limited data available on use of this drug in pregnant women to inform a drug-related risk. Observational studies during the first trimester did not indicate an increased risk of major birth defects after exposure to this drug.

Comments:
-The active component crosses the placenta.
-Intake of this drug shortly before delivery may cause a false positive test for isovaleric acidemia in the newborn as part of neonatal screening; prompt follow-up of positive results are recommended.
-No dose adjustment is recommended in pregnant women based on pharmacokinetics.

Animal studies have failed to reveal evidence of embryofetal toxicity after administration of this drug to pregnant animals during organogenesis at doses up to 7.9 times the daily maximum recommended human dose (MRHD). Slight fetotoxicity (i.e., reduced ossification) was observed in the offspring of animals treated with doses approximately 10.2 times higher than the MRHD based on body surface area. Adverse effects on fertility were not observed in animal studies.

Two cohort studies evaluating exposure to this drug in over 40,000 pregnant women during the first trimester did not observe an increased risk of major birth defects when compared to pregnant women exposed to other antibacterial drugs; studies were limited by potential exposure misclassification.

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

Pivmecillinam Breastfeeding Warnings

Benefit should outweigh risk.
-According to some authorities: Use is considered acceptable.

Excreted into human milk: Yes

Comments:
-Therapeutic doses of this drug are not generally expected to cause adverse effects; however, there are pharmacovigilance reports of adverse reactions in breastfed infants after exposure to the active component (reactions included rash and diarrhea).
-There are no data on the effects of this drug on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this drug against any potential adverse effects on the breastfed child from this drug or from the underlying maternal condition.

See references

Further information

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