ABSTRACT
Background:
Flurbiprofen 8.75 mg lozenges and oromucosal sprays are used for symptomatic relief of
sore throat in
patients aged 12 years and over. The documented adverse events of
flurbiprofen use include those related to its pharmacological actions, namely, increased
risk of haemorrhagic events, however other adverse events (such as nephrotoxicity and
cardiac failure) have been known to occur. The likelihood of occurrence of adverse events increases when
flurbiprofen is used concomitantly with some other medications. Therefore, the objective of this
systematic review was to collate the current evidence on adverse events which occur with
flurbiprofen 8.75 mg
dose (any formulation), in particular as a result of interaction with other medicinal products, with a focus on non-haemorrhagic events.
Methods:
Systematic searches of the
literature were conducted to identify
literature on any formulation of
flurbiprofen 8.75 mg up to the date of the
electronic database search (data lock 28 April 2020).
Publications were screened to identify studies
reporting non-haemorrhagic adverse events with
flurbiprofen 8.75 mg and/or non-haemorrhagic adverse events in the comparator
arm. Data extraction was performed for eligible studies according to pre-defined criteria and summarised in narratives, tables and figures.
Risk of
bias and certainty of evidence assessments were planned for each included study where results relating to the primary objective of the
systematic review were available.
Results:
Of 1,528
publications identified by systematic
literature searches, 26 met the inclusion criteria and were included in this
review. None of these 26 studies contained information on non-haemorrhagic adverse events occurring as a result of a
drug-
drug interaction (interaction with concomitant medication used with
flurbiprofen 8.75 mg), as per the primary objective and
secondary objectives of the
systematic review.
Conclusion:
Results from this
systematic review on the
risk of non-haemorrhagic events did not provide evidence for these events occurring as a result of interaction with other medicinal products. Additional appropriately designed studies would be required to confirm whether these findings suggest a true absence of
risk or limitations in
reporting.