pharmacoepidemiology and drug safety 2015; 24: 286–296 Published online 21 October 2014 in Wiley Online Library (wileyonlinelibrary.com) DOI: 10.1002/pds.3707
ORIGINAL REPORT
A prospective observational study of oseltamivir safety and tolerability in infants and young children ≤24 months†,‡ Barbara A. Rath1*, William A. Blumentals2, Mary K. Miller3, Kathryn Starzyk4, Boguslaw Tetiurka5 and Martina Wollenhaupt6 1
Charité University Medical Center, Berlin, Germany Hoffmann-La Roche, Inc., Nutley, NJ, USA 3 Genentech, Inc., South San Francisco, CA, USA 4 Quintiles Outcome, Cambridge, MA, USA 5 NZOZ Salmed, Leczna, Poland 6 F. Hoffmann-La Roche Ltd., Basel, Switzerland 2
ABSTRACT Purpose 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. Copyright © 2014 John Wiley & Sons, Ltd. key words—oseltamivir; influenza; safety; tolerability; infants; children; pharmacoepidemiology Received 25 March 2014; Revised 23 July 2014; Accepted 12 August 2014
BACKGROUND Children aged
ORIGINAL REPORT
A prospective observational study of oseltamivir safety and tolerability in infants and young children ≤24 months†,‡ Barbara A. Rath1*, William A. Blumentals2, Mary K. Miller3, Kathryn Starzyk4, Boguslaw Tetiurka5 and Martina Wollenhaupt6 1
Charité University Medical Center, Berlin, Germany Hoffmann-La Roche, Inc., Nutley, NJ, USA 3 Genentech, Inc., South San Francisco, CA, USA 4 Quintiles Outcome, Cambridge, MA, USA 5 NZOZ Salmed, Leczna, Poland 6 F. Hoffmann-La Roche Ltd., Basel, Switzerland 2
ABSTRACT Purpose 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. Copyright © 2014 John Wiley & Sons, Ltd. key words—oseltamivir; influenza; safety; tolerability; infants; children; pharmacoepidemiology Received 25 March 2014; Revised 23 July 2014; Accepted 12 August 2014
BACKGROUND Children aged
