Probable topiramate-induced diarrhea in a 2-month-old breast-fed child - A case report
Tone Westergren1, Knut Hjelmeland1, Bjørg Kristoffersen2
1Regional Medicines Information & Pharmacovigilance Centre (RELIS), Department of Pharmacology, Oslo University Hospital, Norway.
Insights
Topiramate in breast milk caused severe diarrhea in an infant. Stopping breastfeeding resolved the infant's symptoms, highlighting potential risks of this epilepsy medication for nursing babies.
Area of Science:
- Pharmacology
- Neonatal Medicine
- Pediatric Gastroenterology
Background:
- Limited data exists on topiramate use in breastfeeding mothers.
- Topiramate is prescribed for epilepsy and can pass into breast milk.
Observation:
- An infant presented with severe, persistent watery diarrhea at 40 days of age.
- The infant was partially breastfed by a mother using topiramate for epilepsy.
- Medical evaluations ruled out infectious causes for the infant's condition.
Findings:
- Topiramate exposure was suspected, leading to breastfeeding suspension.
- Infant's diarrhea resolved within two days of stopping breastfeeding.
- Breast milk analysis revealed a topiramate concentration of 15.7 μmol/L (5.3 μg/mL).
- The infant may have ingested a significant portion of the mother's weight-adjusted dose.
Implications:
- Diarrhea is a known topiramate adverse reaction, potentially causing serious electrolyte disturbances in infants.
- Topiramate concentrations in breast milk can reach levels causing adverse effects.
- This case suggests diarrhea in an infant is a probable adverse drug reaction to topiramate via breastfeeding.
Abstract:
An infant developed a severe condition of recurrent and persistent watery diarrhea at 40 days of age. The child had been partially breast-fed, and the mother used topiramate for epilepsy. Hospital examination excluded a viral or bacterial infection and failed to identify any other potential cause. After two weeks, topiramate exposure was suspected to be the cause, and breast-feeding was suspended. The diarrhea ceased within 2 days. Analysis of the breast milk showed a topiramate concentration of 15.7 μmol/L (5.3 μg/mL). There is little information on the use of topiramate in breast-feeding women. The potential effects on the children are not known. Topiramate passes into breast milk, and the concentration may equal the therapeutic plasma concentration. In this case, the infant may have ingested up to 40% of the mother's weight-adjusted dose. Diarrhea is a well-known adverse reaction to topiramate and has the potential to cause serious electrolyte disturbances in neonates and infants. The condition improved rapidly after suspension of breast-feeding. Topiramate in breast milk may reach levels that cause adverse effects in infants. Based on the adverse reaction profile of topiramate and the milk concentration, the diarrhea was assessed as a probable adverse drug reaction in the infant.


