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Disproportionality analysis of buprenorphine transdermal system and cardiac arrhythmia using FDA and WHO postmarketing reporting system data.

Authors
  • Sessler, Nelson E1
  • Walker, Ekaterina1
  • Chickballapur, Harsha1
  • Kacholakalayil, James1
  • Coplan, Paul M1, 2
  • 1 a Purdue Pharma L.P ., Stamford , CT , USA.
  • 2 b University of Pennsylvania , Philadelphia , PA , USA.
Type
Published Article
Journal
Postgraduate medicine
Publication Date
Jan 01, 2017
Volume
129
Issue
1
Pages
62–68
Identifiers
DOI: 10.1080/00325481.2016.1271698
PMID: 27977317
Source
Medline
Keywords
License
Unknown

Abstract

The signal identified in the transdermal buprenorphine thorough QTc study, which led to a dose limitation in its US label, does not translate into a signal of increased risk for cardiac arrhythmia in real world use, as assessed by this method of analyzing post-market surveillance data.

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