Benefit should outweigh risk

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Risk Summary: Limited data in pregnant women are not sufficient to inform a drug-associated risk for major birth defects or miscarriage; there are risk associated with poorly controlled diabetes in pregnancy.

Comments:
-Treatment of premenopausal anovulatory women may result in resumption of ovulation; these patients should be informed of pregnancy risk.

In animal studies, administration during early pregnancy, organogenesis, and through lactation did not cause adverse effects in rat and rabbit offspring at approximately 4 times the maximum recommended human dose (MRHD). Higher exposures during organogenesis were associated with fetal death and growth retardation in both rats and rabbits; neonatal death during lactation and placental pathology in the absence of maternal toxicity at approximately 20 and 75 times MRHD, respectively. Abnormal blood glucose levels during pregnancy increase the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications, and increase the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity. The use of insulin is generally recommended during pregnancy. There are no adequate and well-controlled studies in pregnant women.

AU TGA pregnancy category B3: 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 have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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

This drug was detected in rat milk, with peak concentrations of approximately 33% that of maternal plasma concentrations 1 hour post dose.

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: Unknown
Excreted into animal milk: Yes

Comments: The effects in the nursing infant are unknown.

See references