PMID- 21448900
OWN - NLM
STAT- MEDLINE
DCOM- 20110902
LR  - 20131121
IS  - 1099-1557 (Electronic)
IS  - 1053-8569 (Linking)
VI  - 20
IP  - 5
DP  - 2011 May
TI  - Safety profile of oseltamivir during the 2009 influenza pandemic.
PG  - 532-43
LID - 10.1002/pds.2136 [doi]
AB  - PURPOSE: This study evaluated the safety of oseltamivir during the 2009 influenza 
      pandemic. METHODS: Case reports were obtained from the Roche safety database. The 
      incidence of adverse events (AEs) during the pandemic (1 May 2009 to 31 December 
      2009) was compared with that beforehand (during previous influenza seasons) for 
      USA and Japan only, as exposure data in other countries were collected 
      inconsistently. Events with significantly higher reporting during the pandemic 
      (lower bound of 95%CI for crude rate ratio >1) were analyzed further. RESULTS: 
      Global exposure in the pandemic and prepandemic periods was 18.3 and 64.7 million 
      patients, respectively. In USA and Japan, exposure was 15.5 (1382 cases, 2225 
      events) and 62.0 million (8387 cases, 12,749 events), respectively. AEs with 
      significantly higher reporting during the pandemic were generally consistent with 
      influenza and its complications and/or with the circulation of a novel virus 
      strain. As might be expected in a pandemic, mortality increased (crude rate 
      ratio, 2.83; 95%CI, 2.23-3.59) versus the prepandemic period. Medical review of 
      serious AEs (fatal or non-fatal outcome) found that most were consistent with 
      pre-existing risk factors, underlying disease, and/or progression of influenza or 
      its complications. Analysis of the remainder did not suggest a causal link with 
      oseltamivir. A review of AEs in previously underexposed subpopulations did not 
      support an association with oseltamivir. CONCLUSIONS: During the first 8 months 
      of the 2009 influenza pandemic, AEs reported in patients exposed to oseltamivir 
      were consistent with the drug's labeled safety profile, underlying medical 
      conditions, or infection with the pandemic virus.
CI  - Copyright (c) 2011 John Wiley & Sons, Ltd.
FAU - Donner, Barbara
AU  - Donner B
AD  - F. Hoffmann-La Roche Ltd, Basel, Switzerland. barbara.donner@roche.com
FAU - Bader-Weder, Silvia
AU  - Bader-Weder S
FAU - Schwarz, Roman
AU  - Schwarz R
FAU - Peng, Michael M
AU  - Peng MM
FAU - Smith, James Robert
AU  - Smith JR
FAU - Niranjan, Viswanathan
AU  - Niranjan V
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Pharmacoepidemiol Drug Saf
JT  - Pharmacoepidemiology and drug safety
JID - 9208369
RN  - 0 (Antiviral Agents)
RN  - 20O93L6F9H (Oseltamivir)
SB  - IM
MH  - Adult
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Aged
MH  - Antiviral Agents/administration & dosage/*adverse effects/therapeutic use
MH  - Child
MH  - Child, Preschool
MH  - Female
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - Influenza, Human/*drug therapy/epidemiology
MH  - Japan/epidemiology
MH  - Male
MH  - Medication Errors/statistics & numerical data
MH  - Middle Aged
MH  - Oseltamivir/administration & dosage/*adverse effects/therapeutic use
MH  - *Pandemics/prevention & control/statistics & numerical data
MH  - United States/epidemiology
MH  - Young Adult
EDAT- 2011/03/31 06:00
MHDA- 2011/09/03 06:00
CRDT- 2011/03/31 06:00
PHST- 2011/03/31 06:00 [entrez]
PHST- 2011/03/31 06:00 [pubmed]
PHST- 2011/09/03 06:00 [medline]
AID - 10.1002/pds.2136 [doi]
PST - ppublish
SO  - Pharmacoepidemiol Drug Saf. 2011 May;20(5):532-43. doi: 10.1002/pds.2136.