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Systematic review of NSAID safety to support reclassification application

  • We conducted a systematic review at the request of the marketing authorisation holder (MAH) on adverse events (AEs) which occur with a non-steroidal anti-inflammatory drug (NSAID) (flurbiprofen 8.75mg), focusing on drug interactions and non-haemorrhagic AEs.
  • Following discussions with the MAH, our experienced systematic review experts formulated the research question and defined inclusion criteria, exclusion criteria and the search strategy.
  • Systematic searches of literature were conducted within these parameters from a defined list of information sources, including PubMed/ MEDLINE, Embase, the Cochrane Library, Web of Science, ClinicalTrials.gov and the EU Clinical Trials Register. The resulting studies were reviewed independently by two DSRU reviewers.
  • In this case, 1528 publications were identified by the search strategy and of these 26 were found to be eligible and met the inclusion criteria. There were no AEs resulting from drug-drug interactions amongst these 26 studies, although 14 studies described non-haemorrhagic events judged to be possibly or probably treatment related.
  • The systematic review contributed to evidence used to support an application reclassify this drug from ‘Prescription Only’ to ‘Not Subject to Medical Prescription’ status in France.
  • This systematic review is published here