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DSRU Systematic Reviews for Safety: latest publication

The DSRU conducts systematic literature reviews to support evidence-based decisions in drug safety.

We recently published a systematic review on the safety of a non-steroidal anti-inflammatory drug (NSAID) that we conducted at the request of the marketing authorisation holder (MAH). The objective of the systematic review was to collate evidence on adverse events (AEs) which occur with this NSAID (flurbiprofen 8.75mg), especially AEs that result from interaction with other drugs. This part of the review focused on non-haemorrhagic AEs.

Following discussions with the MAH, members of the DSRU’s experienced systematic review team 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, which included 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 one or more non-haemorrhagic events considered by the authors to be possibly or probably treatment related. Further research would be required to determine whether the results of this systematic review suggest a true absence of risk or are due to limitations in reporting.

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.

Read the paper in full here: https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2024.1107185/full

Evans, A., Roy, D., Dhanda, S., Lane, S., Coutinho, G., Kulasekaran, A., Miller-Shakesby, D., Ramamoorthi, N., & Shakir, S. (2024). A systematic review of flurbiprofen 8.75 mg dose and risk of adverse events (excluding haemorrhagic) resulting from drug-drug interactions. Frontiers in pharmacology, 15, 1107185. https://doi.org/10.3389/fphar.2024.1107185