The European Medicines Agency'sPharmacovigilance Risk Assessment Committee(PRAC) has recommended that themarketing authorisationfor drugs containing fusafungine be revoked, so the medicines can no longer be marketed in the EU.
It followed a review by PRAC,which concluded that the benefits of fusafungine did not outweigh its risks, particularly the risk of serious allergic reactions.
Fusafungine is an antibiotic and anti-inflammatory nose and mouth spray used to treat upper airway infections such as rhinopharyngitis (common cold).
With regard to the benefits, PRACconsidered that the evidence for beneficial effects of fusafungine is weak.
PRACwas also concerned about the potential for fusafungine to promote antibiotic resistance (the ability of bacteria to grow in the presence of an antibiotic that would normally kill them or limit their growth).