A prospective observational study of oseltamivir safety and tolerability in infants and young children ≤24 months

Rath, Barbara; Blumentals, William A.; Miller, Mary K.; Starzyk, Kathryn; Tetiurka, Bogusław; Wollenhaupt, Martina

doi:10.1002/pds.3707

Cited by 12 publications

(6 citation statements)

References 25 publications

(46 reference statements)

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“…One of the reported SAEs (diarrhoea) prolonged hospitalization: this event was considered of moderate severity by the investigator, and no treatment was given. The safety profile is consistent with previous findings [20][21][22], and with results of a recent European observational study in 1,065 infants aged 0-24 months with influenza [23], which found similar AE rates in oseltamivir-exposed and unexposed patients (49% versus 55%), suggesting a favourable benefit/risk ratio of oseltamivir treatment in infants [23]. The rates of vomiting and diarrhoea in our study were lower than the respective values of 29 and 35% reported in a clinical trial in 202 children aged 1-3 years who received oseltamivir 30-45 mg twice daily depending on body weight [24].…”

Section: Discussionsupporting

confidence: 91%

Safety, Virology and Pharmacokinetics of Oseltamivir in Infants with Laboratory-Confirmed Influenza: A Phase I/II, Prospective, Open-Label, Multicentre Clinical Trial

Rath

Brzostek²,

Guillén

et al. 2014

Antiviral Therapy

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Section: Discussionsupporting

confidence: 91%

Safety, Virology and Pharmacokinetics of Oseltamivir in Infants with Laboratory-Confirmed Influenza: A Phase I/II, Prospective, Open-Label, Multicentre Clinical Trial

Rath

Brzostek²,

Guillén

et al. 2014

Antiviral Therapy

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“…[9,26]. Gastrointestinal symptoms have been observed in about one in four infants with untreated influenza infection [27]. Of note, nonrespiratory symptoms are not included in most ILI/(S)ARI case definitions [1,28,29].…”

Section: Virus-specific Diagnoses Cannot Be Made Based On Clinical Symptoms Alonementioning

confidence: 99%

Are we missing respiratory viral infections in infants and children? Comparison of a hospital-based quality management system with standard of care

Alchikh

Conrad

Hoppe

et al. 2019

Clinical Microbiology and Infection

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“…The efficacy, tolerability, and safety of NA inhibitors for the prevention and management of influenza infections have been demonstrated in large clinical trials that also included infants [ 99 ]. Flu vaccination reduces the incidence of pneumococcal HUS [ 78 ].…”

Section: Therapeutic Management Outcome and Preventionmentioning

confidence: 99%

Influenza-associated thrombotic microangiopathies

Bitzan

Zieg

2017

Pediatr Nephrol

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Thrombotic microangiopathy (TMA) refers to phenotypically similar disorders, including hemolytic uremic syndromes (HUS) and thrombotic thrombocytopenic purpura (TTP). This review explores the role of the influenza virus as trigger of HUS or TTP. We conducted a literature survey in PubMed and Google Scholar using HUS, TTP, TMA, and influenza as keywords, and extracted and analyzed reported epidemiological and clinical data. We identified 25 cases of influenza-associated TMA. Five additional cases were linked to influenza vaccination and analyzed separately. Influenza A was found in 83%, 10 out of 25 during the 2009 A(H1N1) pandemic. Two patients had bona fide TTP with ADAMTS13 activity <10%. Median age was 15 years (range 0.5–68 years), two thirds were male. Oligoanuria was documented in 81% and neurological involvement in 40% of patients. Serum C3 was reduced in 5 out of 14 patients (36%); Coombs test was negative in 7 out of 7 and elevated fibrin/fibrinogen degradation products were documented in 6 out of 8 patients. Pathogenic complement gene mutations were found in 7 out of 8 patients tested (C3, MCP, or MCP combined with CFB or clusterin). Twenty out of 24 patients recovered completely, but 3 died (12%). Ten of the surviving patients underwent plasma exchange (PLEX) therapy, 5 plasma infusions. Influenza-mediated HUS or TTP is rare. A sizable proportion of tested patients demonstrated mutations associated with alternative pathway of complement dysregulation that was uncovered by this infection. Further research is warranted targeting the roles of viral neuraminidase, enhanced virus-induced complement activation and/or ADAMTS13 antibodies, and rational treatment approaches.Electronic supplementary materialThe online version of this article (10.1007/s00467-017-3783-4) contains supplementary material, which is available to authorized users

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A prospective observational study of oseltamivir safety and tolerability in infants and young children ≤24 months

Abstract: 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.

Cited by 12 publications

References 25 publications

Safety, Virology and Pharmacokinetics of Oseltamivir in Infants with Laboratory-Confirmed Influenza: A Phase I/II, Prospective, Open-Label, Multicentre Clinical Trial

Safety, Virology and Pharmacokinetics of Oseltamivir in Infants with Laboratory-Confirmed Influenza: A Phase I/II, Prospective, Open-Label, Multicentre Clinical Trial

Are we missing respiratory viral infections in infants and children? Comparison of a hospital-based quality management system with standard of care

Influenza-associated thrombotic microangiopathies

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