PMID- 23801882
OWN - NLM
STAT- MEDLINE
DCOM- 20140127
LR  - 20220419
IS  - 1449-1907 (Electronic)
IS  - 1449-1907 (Linking)
VI  - 10
IP  - 8
DP  - 2013
TI  - Pneumothorax as an adverse drug event: an exploratory aggregate analysis of the 
      US FDA AERS database including a confounding by indication analysis inspired by 
      Cornfield's condition.
PG  - 965-73
LID - 10.7150/ijms.5377 [doi]
AB  - INTRODUCTION: Pneumothorax is either primary or secondary. Secondary pneumothorax 
      is usually due to trauma, including various non-pharmacologic iatrogenic 
      triggers. Although not normally thought of as an adverse drug event (ADE) 
      secondary pneumothorax is associated with numerous drugs, though it is often 
      difficult to determine whether this association is causal in nature, or reflects 
      an epiphenomenon of efficacy or inefficacy, or confounding by indication (CBI). 
      Herein we explore this association in a large health authority drug safety 
      surveillance database. METHODS: A quantitative pharmacovigilance (PhV) 
      methodology known as disproportionality analysis was applied to the United States 
      Food and Drug Administration (US FDA) Adverse Event Reporting System (AERS) 
      database to explore the quantitative reporting dependencies between drugs and the 
      adverse event pneumothorax as well the corresponding reporting dependencies 
      between drugs and reported indications that may be risk factors for pneumothorax 
      themselves in order to explore the potential contribution of CBI. RESULTS: We 
      found 1. Multiple drugs are associated with pneumothorax; 2. Surfactants and 
      oncology drugs account for most statistically distinctive associations with 
      pneumothorax; 3. Pulmonary surfactants, pentamidine and nitric oxide have the 
      largest statistical reporting associations 4. CBI may play a prominent role in 
      reports of drug-associated pneumothorax. CONCLUSIONS: Disproportionality analysis 
      (DA) can provide insights into the spontaneous reporting dependencies between 
      drugs and pneumothorax. CBI assessment based on DA and Cornfield's inequality 
      presents an additional novel option for the initial exploration of potential 
      safety signals in PhV.
FAU - Hauben, Manfred
AU  - Hauben M
AD  - Pfizer Inc. Manfred.Hauben@Pfizer.com
FAU - Hung, Eric Y
AU  - Hung EY
LA  - eng
PT  - Journal Article
DEP - 20130613
PL  - Australia
TA  - Int J Med Sci
JT  - International journal of medical sciences
JID - 101213954
SB  - IM
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Humans
MH  - Pneumothorax/*chemically induced
MH  - United States
MH  - United States Food and Drug Administration
PMC - PMC3691794
OTO - NOTNLM
OT  - Pneumothorax
OT  - disproportionality analysis
COIS- Competing Interests: Manfred Hauben is a full time employee of, and owns stock 
      and stock options in, Pfizer Inc which manufactures/markets drugs discussed in 
      this article and/or competing drugs from the same pharmacological/therapeutic 
      class as those discussed in this article and owns stock and stock options in 
      other pharmaceutical companies that may manufacture drugs included in this study 
      and/or other drugs within the same pharmacological/therapeutic classes. Eric Hung 
      is a full time employee of Pfizer Inc and owns stock and stock options in Pfizer 
      Inc.
EDAT- 2013/06/27 06:00
MHDA- 2014/01/28 06:00
PMCR- 2013/01/01
CRDT- 2013/06/27 06:00
PHST- 2012/10/12 00:00 [received]
PHST- 2013/03/13 00:00 [accepted]
PHST- 2013/06/27 06:00 [entrez]
PHST- 2013/06/27 06:00 [pubmed]
PHST- 2014/01/28 06:00 [medline]
PHST- 2013/01/01 00:00 [pmc-release]
AID - ijmsv10p0965 [pii]
AID - 10.7150/ijms.5377 [doi]
PST - epublish
SO  - Int J Med Sci. 2013 Jun 13;10(8):965-73. doi: 10.7150/ijms.5377. Print 2013.