PMID- 23129321
OWN - NLM
STAT- MEDLINE
DCOM- 20130927
LR  - 20131121
IS  - 1099-1557 (Electronic)
IS  - 1053-8569 (Linking)
VI  - 22
IP  - 4
DP  - 2013 Apr
TI  - Risk of adverse events following oseltamivir treatment in influenza outpatients, 
      Vaccine Safety Datalink Project, 2007-2010.
PG  - 335-44
LID - 10.1002/pds.3363 [doi]
AB  - PURPOSE: An association between the influenza antiviral medication oseltamivir 
      and neuropsychiatric events has been suggested by post-marketing case reports in 
      Japan. This possible association was not supported by cohort studies in the U.S. 
      conducted prior to the 2009 influenza A (H1N1) pandemic, when usage rates were 
      comparatively low. We assessed oseltamivir safety before and during the pandemic 
      using biologically plausible risk intervals, particularly focusing on psychiatric 
      events. METHODS: Outpatients with influenza episodes from January 2007 through 
      June 2010 were identified using diagnosis codes and positive tests at eight 
      health care systems (sites) in the Vaccine Safety Datalink Project. 
      Oseltamivir-treated and untreated patients were matched according to calendar 
      week, age, sex, site, and propensity for treatment. Within this matched cohort, 
      conditional logistic regression models were used to estimate the risk of four 
      neuropsychiatric and five other adverse events (AEs) during pre-specified risk 
      intervals. RESULTS: Among 27,684 matched pairs, no associations were identified 
      between oseltamivir treatment and any pre-defined AE. The absolute risks of 
      incident psychiatric events in the 1-7 day risk interval were 0.126% for 
      oseltamivir-treated and 0.105% for untreated patients (odds ratio = 1.21, 95% 
      confidence interval [CI]: 0.74, 1.97; risk difference = 0.022%, 95% CI: -0.035%, 
      0.078%); the most common diagnosis was unspecified anxiety state. Results were 
      similar for 1-14 and 1-2 day risk intervals and for pediatric/adolescent 
      subgroups. CONCLUSIONS: Consistent with prior U.S. cohort studies, no evidence 
      was identified for an increased risk of neuropsychiatric or other AEs following 
      oseltamivir treatment. Safety should be prospectively monitored to inform 
      antiviral medication usage recommendations.
CI  - Copyright (c) 2012 John Wiley & Sons, Ltd.
FAU - Greene, Sharon K
AU  - Greene SK
AD  - Department of Population Medicine, Harvard Medical School and Harvard Pilgrim 
      Health Care Institute, Boston, Massachusetts 02215-3920, USA. 
      Sharon_Greene@harvardpilgrim.org
FAU - Li, Lingling
AU  - Li L
FAU - Shay, David K
AU  - Shay DK
FAU - Fry, Alicia M
AU  - Fry AM
FAU - Lee, Grace M
AU  - Lee GM
FAU - Jacobsen, Steven J
AU  - Jacobsen SJ
FAU - Baxter, Roger
AU  - Baxter R
FAU - Irving, Stephanie A
AU  - Irving SA
FAU - Jackson, Michael L
AU  - Jackson ML
FAU - Naleway, Allison L
AU  - Naleway AL
FAU - Nordin, James D
AU  - Nordin JD
FAU - Narwaney, Komal J
AU  - Narwaney KJ
FAU - Lieu, Tracy A
AU  - Lieu TA
LA  - eng
PT  - Journal Article
PT  - Research Support, U.S. Gov't, P.H.S.
DEP - 20121105
PL  - England
TA  - Pharmacoepidemiol Drug Saf
JT  - Pharmacoepidemiology and drug safety
JID - 9208369
RN  - 0 (Antiviral Agents)
RN  - 0 (Influenza Vaccines)
RN  - 20O93L6F9H (Oseltamivir)
SB  - IM
MH  - Antiviral Agents/*adverse effects
MH  - Humans
MH  - Influenza Vaccines/*adverse effects
MH  - Influenza, Human/*prevention & control
MH  - Mental Disorders/chemically induced
MH  - Oseltamivir/*adverse effects
MH  - Risk
EDAT- 2012/11/07 06:00
MHDA- 2013/09/28 06:00
CRDT- 2012/11/07 06:00
PHST- 2012/07/18 00:00 [received]
PHST- 2012/09/27 00:00 [revised]
PHST- 2012/10/02 00:00 [accepted]
PHST- 2012/11/07 06:00 [entrez]
PHST- 2012/11/07 06:00 [pubmed]
PHST- 2013/09/28 06:00 [medline]
AID - 10.1002/pds.3363 [doi]
PST - ppublish
SO  - Pharmacoepidemiol Drug Saf. 2013 Apr;22(4):335-44. doi: 10.1002/pds.3363. Epub 
      2012 Nov 5.