Etonogestrel Pregnancy and Breastfeeding Warnings
Etonogestrel Pregnancy Warnings
Etonogestrel has not been formally assigned to a pregnancy category by the FDA. Animal studies have been performed in rats and rabbits, respectively, using oral administration up to 390 and 790 times the human dose (based upon body surface) and revealed no evidence of fetal harm due to etonogestrel exposure. Studies have revealed no increased risk of birth defects in women who have used combination oral contraceptives before pregnancy or during early pregnancy. There is no evidence that the risk associated with etonogestrel is different from that of combination oral contraceptives. Etonogestrel is considered contraindicated during pregnancy. Etonogestrel implant should be removed if maintaining a pregnancy.
Etonogestrel Breastfeeding Warnings
Small amounts of etonogestrel are excreted in breast milk. Based on limited data, the manufacturer recommends etonogestrel implant may be used during lactation after the 4th postpartum week. Use before the 4th postpartum week has not been studied.
During the first months after etonogestrel implant insertion, when maternal blood levels of etonogestrel are highest, about 100 ng of etonogestrel may be ingested by the child per day based on an average daily milk ingestion of 658 mL. Based on daily milk ingestion of 150 mL/kg, the mean daily infant etonogestrel dose one month after insertion of etonogestrel implant is about 2.2% of the weight-adjusted maternal daily dose, or about 0.2% of the estimated absolute maternal daily dose. The health of breast-fed infants whose mothers began using etonogestrel implant during the 4th to 8th week postpartum (n=38) was evaluated in a comparative study with infants of mothers using a non-hormonal IUD (n=33). They were breast-fed for a mean duration of 14 months and followed up to 36 months of age. No significant effects and no differences between the groups were observed on the physical and psychomotor development of these infants. No differences between groups in the production or quality of breast milk were detected.
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