Is Fexinidazole 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 Fexinidazole. The text below is quoted from that source — it is not our own verdict.
Summary of use during breastfeeding
No adverse effects to breastfed infants have been associated with fexinidazole exposure through breastmilk based on a limited number of reported cases. If a mother requires fexinidazole, it is not a reason to discontinue breastfeeding. Until more data are available, fexinidazole should only be used during breastfeeding with careful infant monitoring for vomiting, insomnia, nausea, tremor, and decreased appetite.
Effects on the breastfed infant
According to the manufacturer, no adverse effects to the breastfed child have been associated with fexinidazole exposure through breastmilk based on a limited number of reported cases.
In a phase 3b, prospective, open-label, non-randomized, cohort study of fexinidazole for treating gambiense African trypanosomiasis in the Democratic Republic of the Congo, 17 infants were breastfed (extent not stated, but probably exclusively). The babies developed normally, except one who died from a neonatal infection and two who died because of anemia in the context of severe or complicated malaria. None of these fatalities were considered related to fexinidazole.[1]
Effects on milk supply
Relevant published information was not found as of the revision date.
Levels in milk
Maternal Levels. Relevant published information was not found as of the revision date.
Infant Levels. Relevant published information was not found as of the revision date.
Source: Drugs and Lactation Database (LactMed), National Institute of Child Health and Human Development (NICHD), via NCBI Bookshelf, record “Fexinidazole” (fexinidazole). 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.