title: A prospective observational study of oseltamivir safety and tolerability in infants and young children ≤24 months.
abstract: OBJECTIVE
  Infants and young children are at elevated risk of influenza-associated complications, but information on the safety of antiviral therapies is limited in this age group.
  
  
  METHODS
  In this prospective open-label observational safety study, children aged ≤24 months with a clinical diagnosis of influenza in routine practice received either no antiviral treatment ('unexposed' group) or oseltamivir treatment or prophylaxis ('exposed' group), according to the physician's judgment. Patients were followed up for 30 days after the baseline visit.
  
  
  RESULTS
  Adverse events (AEs) were analysed in 1065 patients; they were reported in 390/711 (54.9%) in the unexposed group, 167/340 (49.1%) patients in the exposed group, and 6/14 prophylaxis patients. Cough and rhinitis were the most common events, reported more often in unexposed children (22.9 and 20.3% respectively) than in exposed children (13.2 and 10.0%; p < 0.001); pyrexia, diarrhoea and vomiting were less common, occurring at similar rates in exposed and unexposed patients. Nasal congestion (3.5%), bronchitis (5.6%) and upper respiratory tract infection (1.5%) were reported more frequently in exposed patients than in unexposed patients (0.7, 2.7 and 0.1% respectively; p < 0.05). In the exposed group, 11.2% of patients (n = 38) experienced 41 AEs considered at least possibly related to oseltamivir, none being assessed as serious. Overall, there were 79 serious AEs in 59 patients. Eleven discontinued treatment because of an AE.
  
  
  CONCLUSIONS
  Oseltamivir has a good tolerability profile in infants and children aged ≤24 months. These findings contributed to the recent FDA approval of oseltamivir for treating infants aged 2-51 weeks.
authors.affiliation: Charité University Medical Center, Berlin, Germany.
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Rath
authors.forename: William A
authors.initials: WA
authors.lastname: Blumentals
authors.forename: Mary K
authors.initials: MK
authors.lastname: Miller
authors.forename: Kathryn
authors.initials: K
authors.lastname: Starzyk
authors.forename: Boguslaw
authors.initials: B
authors.lastname: Tetiurka
authors.forename: Martina
authors.initials: M
authors.lastname: Wollenhaupt
mesh_terms: D000998:Antiviral Agents / Q000009:adverse effects*; D003371:Cough / Q000139:chemically induced / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007251:Influenza, Human / Q000188:drug therapy* / Q000453:epidemiology*; D008297:Male; D053139:Oseltamivir / Q000009:adverse effects*; D011446:Prospective Studies; D014839:Vomiting / Q000139:chemically induced / Q000453:epidemiology
chemical_list: D000998:Antiviral Agents; D053139:Oseltamivir
keywords: children; infants; influenza; oseltamivir; pharmacoepidemiology; safety; tolerability