title: Treatment of Congenital Toxoplasmosis: Safety of the Sulfadoxine-Pyrimethamine Combination in Children Based on a Method of Causality Assessment.
abstract: The treatment of newborns and infants with congenital toxoplasmosis is standard practice. Some observational studies have examined safety in newborns, but most of these failed to provide sufficient details for a provisional assessment of causality. The aim of this study was to evaluate the clinical and biological adverse effects of the combination of sulfadoxine-pyrimethamine.
  
  
  
  Sixty-five children treated for 1 year with a combination of sulfadoxine-pyrimethamine (1 dose every 10 days) for congenital toxoplasmosis were followed up to evaluate abnormal hematological values and potential adverse events using a standardized method of causality assessment.
  
  
  
  Nine patients (13.8%) presented at least 1 adverse clinical event that was nonspecific, such as diarrhea on the day of drug administration, vomiting and agitation. In 1 patient, erythema appeared at the end of the treatment and resolved within 10 days. None of these events was attributed to the treatment. Six patients (9.2%) developed an adverse hematological event (neutropenia, n = 3; eosinophilia, n = 2 and both anemia and eosinophilia, n = 1) that was considered to be possibly related to the sulfadoxine-pyrimethamine combination. Four treatments were temporarily interrupted, and toxicity was observed after readministration of treatment in 1 case only. However, none of these adverse events was life threatening.
  
  
  
  According to our results and previously published data, the combination of sulfadoxine-pyrimethamine seems to be well tolerated. However, the sample size of our study was too small to rule out the risk of less frequent, but nevertheless severe, reactions and, in particular, of hypersensitivity reactions.
authors.affiliation: From the *Pharmacy, Hôpital de la Croix-Rousse, Lyon, France; †Hospices Civils de Lyon, Institut de Parasitologie Mycologie Médicale, Hôpital de la Croix-Rousse, Lyon, France; ‡Integrative Physiology of the Brain Arousal Systems, Centre de Recherche en Neurosciences de Lyon, INSERM U1028-CNRS UMR 5292, Faculté de Médecine, Université Claude Bernard Lyon 1, Lyon, France; §Pharmacy, Lyon Sud Hospital, Hospices Civils de Lyon, Lyon, France; and ¶Pharmacovigilance Unit, Hospices Civils de Lyon, Lyon, France.
authors.forename: Julie
authors.initials: J
authors.lastname: Teil
authors.forename: Damien
authors.initials: D
authors.lastname: Dupont
authors.forename: Bruno
authors.initials: B
authors.lastname: Charpiat
authors.forename: Stéphane
authors.initials: S
authors.lastname: Corvaisier
authors.forename: Thierry
authors.initials: T
authors.lastname: Vial
authors.forename: Gilles
authors.initials: G
authors.lastname: Leboucher
authors.forename: Martine
authors.initials: M
authors.lastname: Wallon
authors.forename: François
authors.initials: F
authors.lastname: Peyron
mesh_terms: D000962:Antimalarials / Q000009:adverse effects* / Q000627:therapeutic use*; D015984:Causality; D004338:Drug Combinations; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000473:pathology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D011247:Pregnancy; D011739:Pyrimethamine / Q000009:adverse effects* / Q000627:therapeutic use*; D012189:Retrospective Studies; D013413:Sulfadoxine / Q000009:adverse effects* / Q000627:therapeutic use*; D014125:Toxoplasmosis, Congenital / Q000188:drug therapy*
chemical_list: D000962:Antimalarials; D004338:Drug Combinations; C001205:fanasil, pyrimethamine drug combination; D013413:Sulfadoxine; D011739:Pyrimethamine