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Adverse effects in a newborn infant breast-fed by a mother treated with doxepin
O R Frey1, P Scheidt, A I von Brenndorff
1Department of Pharmacy, Hospital of Heidenheim, Germany. otto.frey@t-online.de
Insights
Breastfeeding mothers using doxepin may pose risks to newborns. Infants can experience adverse effects like poor sucking and vomiting due to doxepin accumulation, even with small doses.
Area of Science:
- Neonatal pharmacology
- Maternal-fetal medicine
- Pediatric toxicology
Background:
- Doxepin is a tricyclic antidepressant used to treat depression and anxiety.
- Maternal use of doxepin during pregnancy and lactation necessitates evaluating potential infant exposure and risks.
- Limited data exist on the safety of doxepin transfer to infants via breast milk.
Observation:
- A nine-day-old infant presented with poor sucking, hypotonia, and vomiting.
- The infant's mother was taking doxepin 35 mg/day and breastfeeding.
- Doxepin was detected in the infant's plasma at low levels (approx. 10 µg/L).
Findings:
- Infant ingested approximately 10-20 µg/kg/day of doxepin via breast milk, representing 2.5% of the maternal weight-adjusted dose.
- Adverse effects in the infant resolved within 48 hours after cessation of breastfeeding.
- The active metabolite, N-desmethyldoxepin (DDP), was below the limit of detection in the infant.
Implications:
- Newborns have decreased metabolic capacity, increasing the risk of drug accumulation and adverse effects from doxepin exposure.
- Caution is advised for breastfeeding mothers taking doxepin due to potential risks to the infant.
- Further research with larger datasets is needed to fully assess the safety of breastfeeding while on doxepin therapy.
Objective:
To report adverse effects in a newborn infant whose mother had been treated with doxepin during pregnancy and while breast-feeding.
Case Summary:
The nine-day-old white boy was admitted because of poor sucking and swallowing, with muscle hypotonia and vomiting. He was drowsy and had lost 150 g. At the time of admission, he was breast-fed by his mother who was being treated with doxepin 35 mg/d. Samples of plasma and breast milk were taken and analyzed by HPLC and fluorescence polarization immunoassay. The amount of doxepin and N-desmethyldoxepin (DDP) ingested via breast-feeding was approximately 10-20 micrograms/kg/d (i.e., only 2.5% of the weight-adjusted dose of the mother). Doxepin was detectable in small amounts in the infant's plasma (approximately 10 micrograms/L); DDP was below the lower limit of detection of 10 micrograms/L. All adverse effects subsided within 48 hours after breast-feeding was stopped.
Discussion:
Despite the small doses of doxepin and its active metabolite ingested by breast-fed babies, there is a risk of accumulation and resultant adverse effects. In newborns, the metabolic activity is considerably decreased and may be further reduced by hyperbilirubinemia.
Conclusions:
Available data suggest that women treated with doxepin should breast-feed their infants with great caution, if at all, although much larger databases are needed to confirm this.