Oseni Pregnancy Warnings
Alogliptin: Not teratogenic when administered to animals during organogenesis. In addition, no harm to the developing embryo or adverse effects on the growth and development of offspring was observed when given to animals at approximately 95 times the clinical exposure. Following oral administration to pregnant animals, placental transfer of was observed. Animal fertility studies showed no adverse effects on embryonic development, mating, or fertility at doses approximately 172 times the clinical dose.
Pioglitazone: Animal studies have not revealed evidence of teratogenicity. Increases in embryotoxicity (postimplantation losses, delayed development, reduced fetal weights, and delayed parturition) were observed in animals. When administered to pregnant animals during late gestation and lactation, delayed postnatal development (attributed to decreased body weight) occurred.
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.
Potential benefit should outweigh the potential risk.
FDA pregnancy category: Not assigned
Risk summary: Abnormal blood glucose concentrations during pregnancy are associated with a higher incidence of congenital anomalies, increased neonatal morbidity, and mortality. Most experts recommend insulin use during pregnancy to maintain blood glucose concentrations as close to normal as possible.
Comment: Premenopausal anovulatory women may be at risk for pregnancy with use of pioglitazone; these women should be informed of pregnancy risk.
See references
Oseni Breastfeeding Warnings
A decision should be made to discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Unknown (alogliptin and pioglitazone)
Excreted into animal milk: Yes (alogliptin and pioglitazone)
The effects in the nursing infant are unknown.
See references
