Oseltamivir use for viral pneumonia in newborns

Abstract

Objective: Viruses are demonstrated to be an uncommon etiologic agent of early and late pneumonia. In this study we aimed to investigate the safety and affectivity of oseltamivir use for viral pneumonia in newborns. Methods: This was a retrospective study conducted in a single tertiary neonatal intensive care unit between September 2009 and April 2013. Demographic, clinical and laboratory data before and after treatment, duration of hospitalization, time of clinical improvement were recorded. Results: During the study period, a total of 69 newborn cases who were treated by oseltamivir for H1N1 swine flu (n=12) or suspicious influenza (n=57) were evaluated. Mean birth weight and gestational age were 3100±601 grams and 37.9±1.8 weeks, respectively. On admission, median postnatal age was 20.6 (7-47) days. Oseltamivir, along with supportive care, was administered as 3.0 mg/kg/dose twice a day for 5 days according to the recommendations of Food and Drug Administration (FDA). The median time of initiation of oseltamivir was 2.3 days (1-4) after admission and the median hospitalization day was 10.4 days (5-22). No adverse effects associated with oseltamivir were observed and all patients were discharged after full recovery. Conclusion: Oseltamivir use in addition to supportive therapy seems to be safe and effective in newborns with severe viral pneumonia.

Keywords

• Pneumonia, newborn, antiviral treatment

Yenidoğanlarda viral pnömonide oseltamivir kullanımı

Abstract

Amaç: Yenidoğanlarda en sık pnömoni etkenleri sıklıkla bakteriyel olmakla birlikte daha az sıklıkta viral etkenler de saptanabilmektedir. Yöntemler: Bu çalışmada 2009-2013 yılları arasında Dr. Sami Ulus Kadın Doğum, Çocuk Sağlığı ve Hastalıkları Eğitim ve Araştırma Hastanesi\'nde oseltamivir verilen hastalar retrospektif olarak değerlendirilmiştir. Hastaların demografik ve klinik bulguları ile tedavinin kaçıncı gününde klinik iyileşmenin sağlandığı, hastanede yatış süresi dosyalardan kayıt edilmiştir. Bulgular: Çalışma süresi boyunca kanıtlanmış H1N1 gribi (n=12) ve şüpheli vakalara (n=57) oseltamivir tedavisi verilen hastalar değerlendirilmeye alınmıştır. Ortalama doğum ağırlığı 3100±601 gram ve gestasyonel yaş 37.9±1.8 hafta; ortanca başvuru yaşı 20.6 (7-47) gün olarak bulunmuştur. Oseltamivir, bu vakalarda FDA\'nın acil kullanım izni doğrultusunda oral 3.0 mg/kg/doz, günde iki kez 5 gün boyunca kullanılmıştır. Hastaneye yatışın ardından oseltamivir başlama zamanı 2.3 (1-4) gün olarak saptanmıştır; hastanede yatış süresi ise 10,4 (5-22) gün olarak bulunmuştur. Tedavi sırasında olguların hiçbirinde oseltamivir ilişkili yan etkiler gözlenmemiştir ve tüm vakalar sağlıklı olarak taburcu edilmiştir. Sonuç: Ağır viral pnömoni düşünülen yenidoğan olgularda destek tedavilerinin yanı sıra oseltamivir verilmesi etkin ve güvenilir görülmektedir

Keywords

• Pnömoni, yenidoğan, antiviral tedavi

References

1. Duke T. Neonatal pneumonia in developing countries. Arch Dis Child Fetal Neonatal Ed 2005;90:F211-219.
2. Barnett ED, Klein, JO. Bacterial Infections of the Respira- tory Tract. In: Remington, JS, eds. Infectious Diseases of the Fetus and the Newborn, 7th edn, Philadelphia: Elsevier Saunders, 2010:276.
3. American Academy of Pediatrics. Herpes simplex. In: Pick- ering LK ed. Red Book: 2012 Report of the Committee on Infectious Diseases, 29th edn, Elk Grove Village, IL: Ameri- can Academy of Pediatrics, 2009:398.
4. Swanson EC, Schleiss MR. Congenital cytomegalovirus in- fection: new prospects for prevention and therapy. Pediatr Clin North Am 2013;60:335-349.
5. Randolph AG, Wang EE. Ribavirin for respiratory syncytial virus infection of the lower respiratory tract. Cochrane Da- tabase Syst Rev 2000;CD000181.
6. Pannaraj PS, Tam B, Akan D. Oseltamivir treatment and prophylaxis in a neonatal intensive care unit during a 2009 H1N1 influenza outbreak. J Perinatol 2011;31:487-493.
7. Tasher D, Bishop B, Stein M, Somekh E. Compliance and safety of oseltamivir treatment in children and infants less than one year of age. Harefuah 2012;151:450-454.
8. Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Office of Surveillance and Epide- miology. Pediatric Postmarket Adverse Event Review. 24 April 2012

9. World Health Organization. WHO guidelines for pharmaco- logical management of pandemic (H1N1) 2009 influenza and other influenza viruses. Geneva, Switzerland: World Health Organization; 2010.
10. Acosta EP, Jester P, Gal P, et al. Oseltamivir dosing for influenza infection in premature neonates. J Infect Dis 2010;303:563–566.
11. Stein A, Keller M, Ross S, et al. Pandemic A/H1N1(2009) influenza infections in very-low-birth-weight infants--a case series from the German Neonatal Network. Klin Padi- atr 2011;223:267-270.
12. Takahashi N, Kitajima H, Kusuda S, Morioka I, Itabashi K. Pandemic (H1N1) 2009 in neonates, Japan. Emerg Infect Dis 2011;17:1763-1765.
13. Moscona A. Neuraminidase inhibitors for influenza. N Engl J Med 2005;353:1363-1373.
14. He G, Massarella J, Ward P. Clinical pharmacokinetics of the prodrug oseltamivir and its active metabolite Ro 64- 0802. Clin Pharmacokinet 1999; 37:471-484.
15. Wooltorton E. Oseltamivir (Tamiflu) unsafe in infants under 1 year old. CMAJ 2004;170:336.
16. Zenciroglu A, Kundak AA, Aydin M, et al. Swine influ- enza A (H1N1) virus infection in infants. Eur J Pediatr 2011;170:333-338.
17. Greer LG, Sheffield JS, Rogers VL, et al. Maternal and neo- natal outcomes after antepartum treatment of influenza with antiviral medications. Obstet Gynecol 2010;115:711–716.
18. Svensson T, Granath F, Stephansson O, Kieler H. Birth outcomes among women exposed to neuraminidase in- hibitors during pregnancy. Pharmacoepidemiol Drug Saf 2011;20:1030-1034.
19. Tsagris V, Nika A, Kyriakou D, et al. Influenza A/ H1N1/2009 outbreak in a neonatal intensive care unit. J Hosp Infect 2012;81:36-40.
20. Leick-Courtois C, Haÿs S, Perpoint T, et al. Influenza A H1N1 in neonatal intensive care unit: analysis and lessons. Arch Pediatr 2011;18:1069-1075.
21. Holgate SL, Bekker A, Rabie H, Cotton MF. Oseltamivir use in low-birth weight infants during the 2009 nH1N1 influenza a outbreak in the Western Cape, South Africa. J Trop Pediatr 2012;58:102-106.
22. Roche Laboratories Inc. Tamiflu (oseltamivir phosphate) capsules and oral suspension [package insert]. Nutley, NJ: Roche laboratories, Inc.;2009.