Safety review: Nonsteroidal anti-inflammatory drugs (NSAIDs) and spontaneous abortion

Version 1.0, September 2016

11 October 2016

A review has been carried out of the Product Information documents and package warnings for all non-steroidal anti-inflammatory drugs (NSAIDs) in relation to information provided about the potential increased risk of miscarriage due to exposure in early pregnancy. The evaluation included comparisons of Australian and international product information documents across the range of NSAIDs; a review of mandated warnings, published literature and therapeutic guidelines; and an analysis of case reports from the TGA Adverse Drug Reactions System database.

Report

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Contents

  • Executive summary
  • 1 Introduction
  • 2 Background
  • 3 The safety concern
  • 4 Product Information and Labelling
  • 5 Literature
  • 6 Adverse Drug Reaction System (ADRS) data
  • 7 Discussion
  • References