title: Probable topiramate-induced diarrhea in a 2-month-old breast-fed child - A case report.
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.
authors: Regional Medicines Information & Pharmacovigilance Centre (RELIS), Department of Pharmacology, Oslo University Hospital, Norway.
authors: Tone
authors: T
authors: Westergren
authors: Regional Medicines Information & Pharmacovigilance Centre (RELIS), Department of Pharmacology, Oslo University Hospital, Norway.
authors: Knut
authors: K
authors: Hjelmeland
authors: Dr. Randersgate Medical Centre, Askim, Norway.
authors: Bjørg
authors: B
authors: Kristoffersen
authors: The National Centre for Epilepsy, Oslo University Hospital, Norway ; Department of Pharmacology, Oslo University Hospital, Norway.
authors: Svein Ivar
authors: SI
authors: Johannessen
authors: Institute of Clinical Medicine, University of Oslo, Norway ; Department of Paediatric Medicine, Oslo University Hospital, Norway.
authors: Betty
authors: B
authors: Kalikstad
keywords: Adverse drug reaction; Breast-feeding; Diarrhea; Pharmacokinetics; Topiramate