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Volumn 22, Issue 4, 2013, Pages 335-344

Risk of adverse events following oseltamivir treatment in influenza outpatients, Vaccine Safety Datalink Project, 2007-2010

(13)  Greene, Sharon K a   Li, Lingling a   Shay, David K b   Fry, Alicia M b   Lee, Grace M a,c   Jacobsen, Steven J d   Baxter, Roger e   Irving, Stephanie A f,k   Jackson, Michael L g   Naleway, Allison L h   Nordin, James D i   Narwaney, Komal J j   Lieu, Tracy A a,c,l  


Author keywords

Adverse events; Influenza; Matched cohort; Oseltamivir; Pharmacoepidemiology; Propensity scores; Psychiatric events

Indexed keywords

OSELTAMIVIR;

EID: 84875775602     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.3363     Document Type: Article
Times cited : (19)

References (44)
  • 1
    • 84875763251 scopus 로고    scopus 로고
    • Genentech USA, Inc. Tamiflu (oseltamivir phosphate) capsules and for oral suspension [Package insert]. South San Francisco, CA: Genentech USA, Inc., Available from [4 April 2012].
    • Genentech USA, Inc. Tamiflu (oseltamivir phosphate) capsules and for oral suspension [Package insert]. South San Francisco, CA: Genentech USA, Inc., 2011. Available from http://www.gene.com/gene/products/information/tamiflu/pdf/pi.pdf [4 April 2012].
    • (2011)
  • 2
    • 79952217106 scopus 로고    scopus 로고
    • Antiviral agents for the treatment and chemoprophylaxis of influenza --- recommendations of the Advisory Committee on Immunization Practices (ACIP)
    • Fiore AE, Fry A, Shay D, Gubareva L, Bresee JS, Uyeki TM. Antiviral agents for the treatment and chemoprophylaxis of influenza --- recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2011; 60(1): 1-24.
    • (2011) MMWR Recomm Rep , vol.60 , Issue.1 , pp. 1-24
    • Fiore, A.E.1    Fry, A.2    Shay, D.3    Gubareva, L.4    Bresee, J.S.5    Uyeki, T.M.6
  • 3
    • 84875769370 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration. Tamiflu (oseltamivir phosphate), Available from: [24 May 2012].
    • U.S. Food and Drug Administration. Tamiflu (oseltamivir phosphate), 2006. Available from: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150758.htm [24 May 2012].
    • (2006)
  • 4
    • 33947583709 scopus 로고    scopus 로고
    • New concerns about oseltamivir
    • New concerns about oseltamivir. Lancet 2007; 369(9567): 1056.
    • (2007) Lancet , vol.369 , Issue.9567 , pp. 1056
  • 5
    • 84875782659 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration. Tamiflu (oseltamivir phosphate) capsules and for oral suspension. Detailed view: safety labeling changes approved by FDA Center for Drug Evaluation and Research (CDER) -- January 2008, Available from: [11 April 2012].
    • U.S. Food and Drug Administration. Tamiflu (oseltamivir phosphate) capsules and for oral suspension. Detailed view: safety labeling changes approved by FDA Center for Drug Evaluation and Research (CDER) -- January 2008, 2008. Available from: http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/ucm111024.htm [11 April 2012].
    • (2008)
  • 6
    • 67651017973 scopus 로고    scopus 로고
    • Oseltamivir and abnormal behaviors: true or not?
    • Yorifuji T, Suzuki E, Tsuda T. Oseltamivir and abnormal behaviors: true or not? Epidemiology 2009; 20(4): 619-621.
    • (2009) Epidemiology , vol.20 , Issue.4 , pp. 619-621
    • Yorifuji, T.1    Suzuki, E.2    Tsuda, T.3
  • 7
    • 33744995759 scopus 로고    scopus 로고
    • Oseltamivir and delirious behavior in children with influenza
    • Okumura A, Kubota T, Kato T, Morishima T. Oseltamivir and delirious behavior in children with influenza. Pediatr Infect Dis J 2006; 25(6): 572.
    • (2006) Pediatr Infect Dis J , vol.25 , Issue.6 , pp. 572
    • Okumura, A.1    Kubota, T.2    Kato, T.3    Morishima, T.4
  • 9
    • 35648973206 scopus 로고    scopus 로고
    • The safety of oseltamivir in patients with influenza: analysis of healthcare claims data from six influenza seasons
    • Blumentals WA, Song X. The safety of oseltamivir in patients with influenza: analysis of healthcare claims data from six influenza seasons. MedGenMed 2007; 9(4): 23.
    • (2007) MedGenMed , vol.9 , Issue.4 , pp. 23
    • Blumentals, W.A.1    Song, X.2
  • 10
    • 62549130251 scopus 로고    scopus 로고
    • Incidence of neuropsychiatric adverse events in influenza patients treated with oseltamivir or no antiviral treatment
    • Smith JR, Sacks S. Incidence of neuropsychiatric adverse events in influenza patients treated with oseltamivir or no antiviral treatment. Int J Clin Pract 2009; 63(4): 596-605.
    • (2009) Int J Clin Pract , vol.63 , Issue.4 , pp. 596-605
    • Smith, J.R.1    Sacks, S.2
  • 11
    • 65549115927 scopus 로고    scopus 로고
    • The association between oseltamivir use and adverse neuropsychiatric outcomes among TRICARE beneficiaries, ages 1 through 21 years diagnosed with influenza
    • Casscells SW, Granger E, Kress AM, Linton A. The association between oseltamivir use and adverse neuropsychiatric outcomes among TRICARE beneficiaries, ages 1 through 21 years diagnosed with influenza. Int J Adolesc Med Health 2009; 21(1): 79-89.
    • (2009) Int J Adolesc Med Health , vol.21 , Issue.1 , pp. 79-89
    • Casscells, S.W.1    Granger, E.2    Kress, A.M.3    Linton, A.4
  • 12
    • 84875782817 scopus 로고    scopus 로고
    • Surveillance for adverse events associated with oseltamivir in a healthcare claims database. Pediatric Advisory Committee Meeting. U.S. Food and Drug Administration, May 7, Available from [24 May 2012].
    • Mosholder AD. Surveillance for adverse events associated with oseltamivir in a healthcare claims database. Pediatric Advisory Committee Meeting. U.S. Food and Drug Administration, May 7, 2012. Available from http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/UCM303006.pdf [24 May 2012].
    • (2012)
    • Mosholder, A.D.1
  • 13
    • 79955660384 scopus 로고    scopus 로고
    • A pharmacoepidemiologic study on the relationship between neuropsychiatric symptoms and therapeutic drugs after influenza infection [in Japanese]
    • Fujita T, Fujii Y, Watanabe Y, et al. A pharmacoepidemiologic study on the relationship between neuropsychiatric symptoms and therapeutic drugs after influenza infection [in Japanese]. Jpn J Pharmacoepidemiol 2010; 15(2): 73-95.
    • (2010) Jpn J Pharmacoepidemiol , vol.15 , Issue.2 , pp. 73-95
    • Fujita, T.1    Fujii, Y.2    Watanabe, Y.3
  • 14
    • 56749106483 scopus 로고    scopus 로고
    • Assessment of neuropsychiatric adverse events in influenza patients treated with oseltamivir: a comprehensive review
    • Toovey S, Rayner C, Prinssen E, et al. Assessment of neuropsychiatric adverse events in influenza patients treated with oseltamivir: a comprehensive review. Drug Saf 2008; 31(12): 1097-1114.
    • (2008) Drug Saf , vol.31 , Issue.12 , pp. 1097-1114
    • Toovey, S.1    Rayner, C.2    Prinssen, E.3
  • 15
    • 84867700265 scopus 로고    scopus 로고
    • Patterns in influenza antiviral medication use before and during the 2009 H1N1 pandemic, Vaccine Safety Datalink Project, 2000-2010
    • Greene SK, Shay DK, Yin R, et al. Patterns in influenza antiviral medication use before and during the 2009 H1N1 pandemic, Vaccine Safety Datalink Project, 2000-2010. Influenza Other Respi Viruses 2012; 6(6): e143-e151.
    • (2012) Influenza Other Respi Viruses , vol.6 , Issue.6
    • Greene, S.K.1    Shay, D.K.2    Yin, R.3
  • 17
    • 0007630202 scopus 로고
    • Psychoses associated with influenza
    • Menninger KA. Psychoses associated with influenza. JAMA 1919; 72(4): 235-241.
    • (1919) JAMA , vol.72 , Issue.4 , pp. 235-241
    • Menninger, K.A.1
  • 18
    • 0036720453 scopus 로고    scopus 로고
    • Encephalitis and encephalopathy associated with an influenza epidemic in Japan
    • Morishima T, Togashi T, Yokota S, et al. Encephalitis and encephalopathy associated with an influenza epidemic in Japan. Clin Infect Dis 2002; 35(5): 512-517.
    • (2002) Clin Infect Dis , vol.35 , Issue.5 , pp. 512-517
    • Morishima, T.1    Togashi, T.2    Yokota, S.3
  • 19
    • 13744252411 scopus 로고    scopus 로고
    • Neurologic complications associated with influenza A in children during the 2003-2004 influenza season in Houston, Texas
    • Maricich SM, Neul JL, Lotze TE, et al. Neurologic complications associated with influenza A in children during the 2003-2004 influenza season in Houston, Texas. Pediatrics 2004; 114(5): e626-633.
    • (2004) Pediatrics , vol.114 , Issue.5
    • Maricich, S.M.1    Neul, J.L.2    Lotze, T.E.3
  • 20
    • 28944434329 scopus 로고    scopus 로고
    • Influenza-associated deaths among children in the United States, 2003-2004
    • Bhat N, Wright JG, Broder KR, et al. Influenza-associated deaths among children in the United States, 2003-2004. N Engl J Med 2005; 353(24): 2559-2567.
    • (2005) N Engl J Med , vol.353 , Issue.24 , pp. 2559-2567
    • Bhat, N.1    Wright, J.G.2    Broder, K.R.3
  • 21
    • 33847287697 scopus 로고    scopus 로고
    • Neurologic complications in children hospitalized with influenza: characteristics, incidence, and risk factors
    • Newland JG, Laurich VM, Rosenquist AW, et al. Neurologic complications in children hospitalized with influenza: characteristics, incidence, and risk factors. J Pediatr 2007; 150(3): 306-310.
    • (2007) J Pediatr , vol.150 , Issue.3 , pp. 306-310
    • Newland, J.G.1    Laurich, V.M.2    Rosenquist, A.W.3
  • 22
    • 78650161021 scopus 로고    scopus 로고
    • Pediatric neurologic complications associated with influenza A H1N1
    • Landau YE, Grisaru-Soen G, Reif S, Fattal-Valevski A. Pediatric neurologic complications associated with influenza A H1N1. Pediatr Neurol 2010; 44(1): 47-51.
    • (2010) Pediatr Neurol , vol.44 , Issue.1 , pp. 47-51
    • Landau, Y.E.1    Grisaru-Soen, G.2    Reif, S.3    Fattal-Valevski, A.4
  • 23
    • 67651091664 scopus 로고    scopus 로고
    • Neurologic complications associated with novel influenza A (H1N1) virus infection in children - Dallas, Texas, May 2009
    • U.S. Centers for Disease Control and Prevention.
    • U.S. Centers for Disease Control and Prevention. Neurologic complications associated with novel influenza A (H1N1) virus infection in children - Dallas, Texas, May 2009. MMWR Morb Mortal Wkly Rep 2009; 58(28): 773-778.
    • (2009) MMWR Morb Mortal Wkly Rep , vol.58 , Issue.28 , pp. 773-778
  • 24
    • 84875796267 scopus 로고    scopus 로고
    • Tamiflu (oseltamivir phosphate) pediatric safety update: Background summary and review of clinical review team activities, to present. 2012. FDA Center for Drug Evaluation and Research. Available from: [24 May 2012].
    • Lewis LL. Tamiflu (oseltamivir phosphate) pediatric safety update: Background summary and review of clinical review team activities, 2007 to present. 2012. FDA Center for Drug Evaluation and Research. Available from: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/UCM302462.pdf [24 May 2012].
    • (2007)
    • Lewis, L.L.1
  • 25
    • 79952474136 scopus 로고    scopus 로고
    • The Vaccine Safety Datalink: a model for monitoring immunization safety
    • Baggs J, Gee J, Lewis E, et al. The Vaccine Safety Datalink: a model for monitoring immunization safety. Pediatrics 2011; 127(1): S45-53.
    • (2011) Pediatrics , vol.127 , Issue.1
    • Baggs, J.1    Gee, J.2    Lewis, E.3
  • 26
    • 2642513257 scopus 로고    scopus 로고
    • Quality assessments of HMO diagnosis databases used to monitor childhood vaccine safety
    • Mullooly J, Drew L, DeStefano F, et al. Quality assessments of HMO diagnosis databases used to monitor childhood vaccine safety. Methods Inf Med 2004; 43(2): 163-170.
    • (2004) Methods Inf Med , vol.43 , Issue.2 , pp. 163-170
    • Mullooly, J.1    Drew, L.2    DeStefano, F.3
  • 27
    • 65249188436 scopus 로고    scopus 로고
    • Swine influenza A (H1N1) infection in two children--Southern California, March-April 2009
    • U.S. Centers for Disease Control and Prevention.
    • U.S. Centers for Disease Control and Prevention. Swine influenza A (H1N1) infection in two children--Southern California, March-April 2009. MMWR Morb Mortal Wkly Rep 2009; 58(15): 400-402.
    • (2009) MMWR Morb Mortal Wkly Rep , vol.58 , Issue.15 , pp. 400-402
  • 28
    • 77950933862 scopus 로고    scopus 로고
    • Negative controls: a tool for detecting confounding and bias in observational studies
    • Lipsitch M, Tchetgen E, Cohen T. Negative controls: a tool for detecting confounding and bias in observational studies. Epidemiology 2010; 21(3): 383-388.
    • (2010) Epidemiology , vol.21 , Issue.3 , pp. 383-388
    • Lipsitch, M.1    Tchetgen, E.2    Cohen, T.3
  • 29
    • 84949193513 scopus 로고
    • Reducing bias in observational studies using subclassification on the propensity score
    • Rosenbaum PR, Rubin DB. Reducing bias in observational studies using subclassification on the propensity score. J Am Stat Assoc 1984; 79(387): 516-524.
    • (1984) J Am Stat Assoc , vol.79 , Issue.387 , pp. 516-524
    • Rosenbaum, P.R.1    Rubin, D.B.2
  • 30
    • 79961226937 scopus 로고    scopus 로고
    • Multivariate and propensity score matching software with automated balance optimization: the matching package for R
    • Sekhon JS. Multivariate and propensity score matching software with automated balance optimization: the matching package for R. J Stat Software 2011; 42(7): 1-52.
    • (2011) J Stat Software , vol.42 , Issue.7 , pp. 1-52
    • Sekhon, J.S.1
  • 31
    • 80054734942 scopus 로고    scopus 로고
    • Referral to an extracorporeal membrane oxygenation center and mortality among patients with severe 2009 influenza A(H1N1)
    • Noah MA, Peek GJ, Finney SJ, et al. Referral to an extracorporeal membrane oxygenation center and mortality among patients with severe 2009 influenza A(H1N1). JAMA 2011; 306(15): 1659-1668.
    • (2011) JAMA , vol.306 , Issue.15 , pp. 1659-1668
    • Noah, M.A.1    Peek, G.J.2    Finney, S.J.3
  • 32
    • 17844393082 scopus 로고    scopus 로고
    • Reader's guide to critical appraisal of cohort studies: 2. Assessing potential for confounding
    • Mamdani M, Sykora K, Li P, et al. Reader's guide to critical appraisal of cohort studies: 2. Assessing potential for confounding. Br Med J 2005; 330(7497): 960-962.
    • (2005) Br Med J , vol.330 , Issue.7497 , pp. 960-962
    • Mamdani, M.1    Sykora, K.2    Li, P.3
  • 33
    • 84857159967 scopus 로고    scopus 로고
    • Signal identification and evaluation for risk of febrile seizures in children following trivalent inactivated influenza vaccine in the Vaccine Safety Datalink Project, 2010-2011
    • Tse A, Tseng HF, Greene SK, Vellozzi C, Lee GM. Signal identification and evaluation for risk of febrile seizures in children following trivalent inactivated influenza vaccine in the Vaccine Safety Datalink Project, 2010-2011. Vaccine 2012; 30(11): 2024-2031.
    • (2012) Vaccine , vol.30 , Issue.11 , pp. 2024-2031
    • Tse, A.1    Tseng, H.F.2    Greene, S.K.3    Vellozzi, C.4    Lee, G.M.5
  • 34
    • 42149166157 scopus 로고    scopus 로고
    • Fatal neuropsychiatric adverse reactions to oseltamivir: Case series and overview of causal relationships
    • Hama R. Fatal neuropsychiatric adverse reactions to oseltamivir: Case series and overview of causal relationships. Int J Risk Saf Med 2008; 20: 5-36.
    • (2008) Int J Risk Saf Med , vol.20 , pp. 5-36
    • Hama, R.1
  • 35
    • 77749326569 scopus 로고    scopus 로고
    • Possible neuropsychiatric reaction to high-dose oseltamivir during acute 2009 H1N1 influenza A infection
    • Nakamura K, Schwartz BS, Lindegardh N, Keh C, Guglielmo BJ. Possible neuropsychiatric reaction to high-dose oseltamivir during acute 2009 H1N1 influenza A infection. Clin Infect Dis 2010; 50(7): e47-49.
    • (2010) Clin Infect Dis , vol.50 , Issue.7
    • Nakamura, K.1    Schwartz, B.S.2    Lindegardh, N.3    Keh, C.4    Guglielmo, B.J.5
  • 36
    • 84875797591 scopus 로고    scopus 로고
    • Tamiflu[R] (oseltamivir) Safety Update. Pediatric Advisory Committee Meeting. FDA Center for Drug Evaluation and Research, November 16, Available from: [15 November 2011].
    • Johann-Liang R, Mosholder A. Tamiflu[R] (oseltamivir) Safety Update. Pediatric Advisory Committee Meeting. FDA Center for Drug Evaluation and Research, November 16, 2006. Available from: www.fda.gov/ohrms/dockets/AC/06/slides/2006-4254s_09_Johann-Liang_Tamiflu.ppt [15 November 2011].
    • (2006)
    • Johann-Liang, R.1    Mosholder, A.2
  • 37
    • 84875778455 scopus 로고    scopus 로고
    • R Development Core Team. R: A language and environment for statistical computing. Vienna, Austria: R Foundation for Statistical Computing, ISBN: 3-900051-07-0
    • R Development Core Team. R: A language and environment for statistical computing. Vienna, Austria: R Foundation for Statistical Computing, 2009. ISBN: 3-900051-07-0, URL http://www.R-project.org
    • (2009)
  • 38
    • 82755192487 scopus 로고    scopus 로고
    • Oseltamivir prescription and regulatory actions vis-a-vis abnormal behavior risk in Japan: drug utilization study using a nationwide pharmacy database
    • Urushihara H, Doi Y, Arai M, et al. Oseltamivir prescription and regulatory actions vis-a-vis abnormal behavior risk in Japan: drug utilization study using a nationwide pharmacy database. PLoS One 2011; 6(12): e28483.
    • (2011) PLoS One , vol.6 , Issue.12
    • Urushihara, H.1    Doi, Y.2    Arai, M.3
  • 39
    • 84870492394 scopus 로고    scopus 로고
    • Biologically plausible and evidence-based risk intervals in immunization safety research
    • Epub ahead of print].
    • Rowhani-Rahbar A, Klein NP, Dekker CL, et al. Biologically plausible and evidence-based risk intervals in immunization safety research. Vaccine 2012. [Epub ahead of print].
    • (2012) Vaccine
    • Rowhani-Rahbar, A.1    Klein, N.P.2    Dekker, C.L.3
  • 40
    • 34748847390 scopus 로고    scopus 로고
    • Impact of safety alerts on measures of disproportionality in spontaneous reporting databases: the notoriety bias
    • Pariente A, Gregoire F, Fourrier-Reglat A, Haramburu F, Moore N. Impact of safety alerts on measures of disproportionality in spontaneous reporting databases: the notoriety bias. Drug Saf 2007; 30(10): 891-898.
    • (2007) Drug Saf , vol.30 , Issue.10 , pp. 891-898
    • Pariente, A.1    Gregoire, F.2    Fourrier-Reglat, A.3    Haramburu, F.4    Moore, N.5
  • 41
    • 84856038227 scopus 로고    scopus 로고
    • A systematic review of validated methods for identifying depression using administrative data
    • Townsend L, Walkup JT, Crystal S, Olfson M. A systematic review of validated methods for identifying depression using administrative data. Pharmacoepidemiol Drug Saf 2012; 21(1): 163-173.
    • (2012) Pharmacoepidemiol Drug Saf , vol.21 , Issue.1 , pp. 163-173
    • Townsend, L.1    Walkup, J.T.2    Crystal, S.3    Olfson, M.4
  • 42
    • 84856039801 scopus 로고    scopus 로고
    • A systematic review of validated methods for identifying suicide or suicidal ideation using administrative or claims data
    • Walkup JT, Townsend L, Crystal S, Olfson M. A systematic review of validated methods for identifying suicide or suicidal ideation using administrative or claims data. Pharmacoepidemiol Drug Saf 2012; 21(1): 174-182.
    • (2012) Pharmacoepidemiol Drug Saf , vol.21 , Issue.1 , pp. 174-182
    • Walkup, J.T.1    Townsend, L.2    Crystal, S.3    Olfson, M.4
  • 43
    • 0023092594 scopus 로고
    • A new method of classifying prognostic comorbidity in longitudinal studies: development and validation
    • Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis 1987; 40(5): 373-383.
    • (1987) J Chronic Dis , vol.40 , Issue.5 , pp. 373-383
    • Charlson, M.E.1    Pompei, P.2    Ales, K.L.3    MacKenzie, C.R.4
  • 44
    • 0026639706 scopus 로고
    • Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases
    • Deyo RA, Cherkin DC, Ciol MA. Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases. J Clin Epidemiol 1992; 45(6): 613-619.
    • (1992) J Clin Epidemiol , vol.45 , Issue.6 , pp. 613-619
    • Deyo, R.A.1    Cherkin, D.C.2    Ciol, M.A.3


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