Safety of oseltamivir compared with the adamantanes in children less than 12 months of age

David W. Kimberlin, Marwan Shalabi, Mark J. Abzug, David Lang, Richard F. Jacobs, Gregory Storch, John S. Bradley, Kelly C. Wade, Octavio Ramilo, José R. Romero, Mark Shelton, Charles Leach, Judith Guzman-Cottrill, Joan Robinson, Nazha Abughali, Janet Englund, Jill Griffin, Penny Jester, Gretchen A. Cloud, Richard J. Whitley

Research output: Contribution to journalArticle

41 Citations (Scopus)

Abstract

Background: When oseltamivir is administered in extremely high doses (500-1000 mg/kg) to young juvenile rats, central nervous system toxicity and death occurred in some animals. Mortality was not observed in older juvenile rats, suggesting a possible relationship between neurotoxicity and an immature blood-brain barrier. To assess potential neurologic adverse effects of oseltamivir use in infants, a retrospective chart review was performed in infants less than 12 months of age who received oseltamivir, amantadine, or rimantadine. Methods: The primary objective was to describe the frequency of neurologic adverse events among children less than 12 months of age who received oseltamivir compared with those receiving adamantanes. Medical record databases, emergency department databases, and/or pharmacy records at 15 medical centers were searched to identify patients. Results: Of the 180 infants identified as having received antiviral therapy, 115 (64%) received oseltamivir, 37 (20%) received amantadine, and 28 (16%) received rimantadine. The median dose of oseltamivir was 2.0 mg/kg/dose in 3-to 5-month-old and 2.2 mg/kg/dose in 9-to 12-month-old infants. The maximum dose administered was 7.0 mg/kg/dose. There were no statistically significant differences in the occurrence of adverse neurologic events during therapy among subjects treated with oseltamivir versus those treated with the adamantanes (P = 0.13). Conclusions: This is the largest report to date of oseltamivir use in children less than 12 months of age. Neurologic events were not more common with use of oseltamivir compared with that of the adamantanes. Dosing of oseltamivir was variable, illustrating the need for pharmacokinetic data in this younger population.

Original languageEnglish (US)
Pages (from-to)195-198
Number of pages4
JournalPediatric Infectious Disease Journal
Volume29
Issue number3
DOIs
StatePublished - Mar 2010
Externally publishedYes

Fingerprint

Adamantane
Oseltamivir
Safety
Nervous System
Rimantadine
Amantadine
Databases
Blood-Brain Barrier
Medical Records
Antiviral Agents
Hospital Emergency Service
Central Nervous System
Pharmacokinetics

Keywords

  • Adamantanes
  • Antiviral
  • Children
  • Infant
  • Neuraminidase inhibitor
  • Oseltamivir
  • Safety

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Infectious Diseases
  • Microbiology (medical)

Cite this

Kimberlin, D. W., Shalabi, M., Abzug, M. J., Lang, D., Jacobs, R. F., Storch, G., ... Whitley, R. J. (2010). Safety of oseltamivir compared with the adamantanes in children less than 12 months of age. Pediatric Infectious Disease Journal, 29(3), 195-198. https://doi.org/10.1097/INF.0b013e3181bbf26b

Safety of oseltamivir compared with the adamantanes in children less than 12 months of age. / Kimberlin, David W.; Shalabi, Marwan; Abzug, Mark J.; Lang, David; Jacobs, Richard F.; Storch, Gregory; Bradley, John S.; Wade, Kelly C.; Ramilo, Octavio; Romero, José R.; Shelton, Mark; Leach, Charles; Guzman-Cottrill, Judith; Robinson, Joan; Abughali, Nazha; Englund, Janet; Griffin, Jill; Jester, Penny; Cloud, Gretchen A.; Whitley, Richard J.

In: Pediatric Infectious Disease Journal, Vol. 29, No. 3, 03.2010, p. 195-198.

Research output: Contribution to journalArticle

Kimberlin, DW, Shalabi, M, Abzug, MJ, Lang, D, Jacobs, RF, Storch, G, Bradley, JS, Wade, KC, Ramilo, O, Romero, JR, Shelton, M, Leach, C, Guzman-Cottrill, J, Robinson, J, Abughali, N, Englund, J, Griffin, J, Jester, P, Cloud, GA & Whitley, RJ 2010, 'Safety of oseltamivir compared with the adamantanes in children less than 12 months of age', Pediatric Infectious Disease Journal, vol. 29, no. 3, pp. 195-198. https://doi.org/10.1097/INF.0b013e3181bbf26b
Kimberlin, David W. ; Shalabi, Marwan ; Abzug, Mark J. ; Lang, David ; Jacobs, Richard F. ; Storch, Gregory ; Bradley, John S. ; Wade, Kelly C. ; Ramilo, Octavio ; Romero, José R. ; Shelton, Mark ; Leach, Charles ; Guzman-Cottrill, Judith ; Robinson, Joan ; Abughali, Nazha ; Englund, Janet ; Griffin, Jill ; Jester, Penny ; Cloud, Gretchen A. ; Whitley, Richard J. / Safety of oseltamivir compared with the adamantanes in children less than 12 months of age. In: Pediatric Infectious Disease Journal. 2010 ; Vol. 29, No. 3. pp. 195-198.
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AU - Jacobs, Richard F.

AU - Storch, Gregory

AU - Bradley, John S.

AU - Wade, Kelly C.

AU - Ramilo, Octavio

AU - Romero, José R.

AU - Shelton, Mark

AU - Leach, Charles

AU - Guzman-Cottrill, Judith

AU - Robinson, Joan

AU - Abughali, Nazha

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