Is Ulipristal safe while breastfeeding?
Here is what LactMed, the Drugs and Lactation Database published by the U.S. National Institute of Child Health and Human Development (NICHD), reports about Ulipristal. The text below is quoted from that source — it is not our own verdict.
Summary of use during breastfeeding
Ulipristal is a selective progesterone receptor modulator used in a single dose as an emergency postcoital contraceptive. No information is available on the clinical use of ulipristal during breastfeeding; however, amounts in milk are low. If ulipristal is required by the mother, it is not a reason to discontinue breastfeeding. Some older sources recommend withholding breastfeeding for 24 hours after a dose,[1] but this is no longer a requirement according to current FDA-approved labeling.
Effects on the breastfed infant
Relevant published information was not found as of the revision date.
Effects on milk supply
Relevant published information was not found as of the revision date.
Levels in milk
Ulipristal acetate is metabolized to mono- and di-demethylated metabolites by CYP3A4. Monodemethyl-ulipristal is pharmacologically active.
Maternal Levels. The breastmilk of 12 lactating women following administration of ulipristal (dosage not stated, but presumably 30 mg) was collected in 24-hour increments to measure the concentrations of ulipristal acetate and monodemethyl-ulipristal acetate in breastmilk. The mean daily concentrations of ulipristal acetate in breastmilk were 22.7 mcg/L (0 to 24 hours), 2.96 mcg/L (24 to 48 hours), 1.56 mcg/L (48 to 72 hours), 1.04 mcg/L (72 to 96 hours), and 0.69 mcg/L (96 to 120 hours). The mean daily concentrations of monodemethyl-ulipristal acetate in breastmilk were 4.49 mcg/L (0 to 24 hours), 0.62 mcg/L (24 to 48 hours), 0.28 mcg/L (48 to 72 hours), 0.17 mcg/L (72 to 96 hours), and 0.10 mcg/L (96 to 120 hours). Using these data, a fully breastfed infant would receive about 4.1 mcg/kg of drug plus active metabolite on the first day and a total of 5.2 mcg/kg over 5 days).[2] Assuming a 30 mg dose and an average maternal weight of 60 kg, the infant would receive a weight-adjusted dosage of 0.8% of drug plus active metabolite on the first day and a total of 1% of the maternal dose over the 5-day period.
Infant Levels. Relevant published information was not found as of the revision date.
Alternatives LactMed lists
“No published information” means the studies do not exist yet — not that Ulipristal is known to be harmful, and not that it is known to be safe. Your prescriber or pharmacist can weigh your baby's age and whether a better-studied alternative would do the same job. Worth asking before stopping a medicine you need.
Source: Drugs and Lactation Database (LactMed), National Institute of Child Health and Human Development (NICHD), via NCBI Bookshelf, record “Ulipristal” (LM1090). LactMed on NCBI Bookshelf. LactMed is a registered trademark of the U.S. Department of Health and Human Services.
Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.