Revised SPC: Froben (flurbiprofen) 100 mg Tablets
SPC now carries a warning that flurbiprofen can mask symptoms of infection with advice for caution if a patient currently has an infection. It also includes updated information use during pregnancy.
Source:
electronic Medicines compendium
SPS commentary:
In July 2023, the EMA's pharmacovigilance risk assessment committee (PRAC) advised that flurbiprofen products (systemic, oromucosal formulations and transdermal patches) carry additional warnings. This was based on periodic safety update reports from marketing authorisation holders. They said that a new warning was required on the possible masking effect of flurbiprofen for the symptoms of infection, with consequent delay in the initiation of appropriate treatment and worsening of the infection. In addition, all flurbiprofen products with oromucosal formulations and transdermal patches should be updated to include a contraindication and a warning on the risk of topical flurbiprofen use in pregnancy.