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Review of Aspirin / Reye's syndrome warning statement

30 April 2004

As part of the Review of non-prescription analgesics (1998) and the subsequent Review of non-prescription analgesics - an update (2003), recommendations were made regarding changes to the cautionary and advisory statements required on the labels of non-prescription analgesics containing aspirin or NSAIDs. After recent changes to the recommended aspirin warning statements regarding Reye's Syndrome in the UK, the Update recommended consideration of the UK warning statement for adoption in Australia.

At its meeting on 3 April 2003, the MEC agreed to re-examine the evidence linking aspirin use in children or teenagers with chicken pox, influenza or fever, with Reye's Syndrome, with a view to making further recommendations to the NDPSC about the advisability of adopting the UK warning statement. The purpose of this review is to provide advice on the current evidence linking aspirin use in children or teenagers to Reye's Syndrome and the suitability/necessity of adopting the UK warning statement.

How to access a pdf document

Review of Aspirin / Reye's syndrome warning statement (pdf,114kb)

Contents

  • Review of aspirin/Reye's Syndrome warning statement
    • Acknowledgements
    • Abbreviations
  • Introduction
    • Background
    • Terms of reference
    • History of Appendix F warning statement
    • Recent overseas regulatory action
  • What is Reye's Syndrome?
  • The association between aspirin and Reye's Syndrome
    • Epidemiology studies
    • The Australian situation
    • Mechanism of action of aspirin in Reye's Syndrome
  • Incidence of Reye's Syndrome
    • Incidence of Reye's Syndrome in the UK
    • Incidence of Reye's Syndrome in Australia
    • Incidence of Reye's Syndrome in the US
  • Summary
  • Recommendation
  • References

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