Animal studies have revealed evidence of embryofetal lethality and malformations at maternotoxic doses. In rats administered this drug by oral gavage during organogenesis, a statistically significant 14% decrease in maternal net body weight gain was observed at 100 mg/kg twice daily (63 times the maximum recommended human dose [MRHD], based on AUC) with associated decrease in food intake; enlarged/fused placenta and/or distended amniotic sac, an increase in postimplantation loss (early and late resorptions), a decrease in mean number of viable fetuses, lower mean fetal weights, and external, visceral, and skeletal malformations were observed at 100 mg/kg twice daily, while no maternal or embryofetal toxicity was observed up to 25 mg/kg twice daily (13 times MRHD, based on AUC). In rats administered this drug by oral gavage during organogenesis and continuing to weaning, dystocia was observed at doses at least 13 times MRHD (based on AUC), while at 63 times MRHD (based on AUC), decreased maternal body weight gain, prolonged parturition, and dystocia occurred and resulted in maternal mortality, complete litter loss, decreased pup viability, and decreased pup body weight; no adverse effects on pup growth and development, and reproductive performance were observed up to 13 times MRHD (based on AUC). In rabbits administered twice daily doses by oral gavage during organogenesis, lower fetal weight (associated with reduced maternal body weight gain) was observed at 62.5 mg/kg twice daily (3 times MRHD, based on AUC); no effects on fetal morphology were observed. There are no controlled data in human pregnancy.

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.

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned.

Risk summary: Insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Disease-associated maternal risk: Untreated pyruvate kinase deficiency in pregnant women may precipitate acute hemolysis, preterm labor, miscarriage, and severe anemia requiring frequent transfusion; also, preeclampsia and severe hypertension have been reported.

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Benefit should outweigh risk.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments:
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.

See references