Is Lofexidine 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 Lofexidine. The text below is quoted from that source — it is not our own verdict.
Summary of use during breastfeeding
No data are available in nursing mothers on the excretion into milk or safety of lofexidine in nursing mothers. A computer model predicted a maximum relative infant dose of about 3%, which should be acceptable. Although it is not contraindicated during breastfeeding, lofexidine should be used with caution until more data are available. An alternate drug may be preferred, especially while nursing a newborn or preterm infant.
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
Maternal Levels. A pharmacokinetic model was designed using in vitro-in vivo techniques that were then used to create a physiologically based pharmacokinetic model of lofexidine. A simulation of administering a dose of lofexidine to nursing mothers resulted in peak milk levels of about 4 mcg/L with a single 1.2 mg dose and 6 mcg/L with a single 2 mg dose assuming milk pH to be 6.8. Excretion was pH-sensitive, with levels dropping by over 90% at a pH of 7.[1] Using the peak level from a 2 mg maternal dose, the worst-case relative infant dose would be about 3%.
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 Lofexidine 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 “Lofexidine” (LM1387). 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.