CMDh endorses revocation of authorisations for fusafungine sprays used to treat airway infections
The CMDh has endorsed by consensus the revocation of marketing authorisations for fusafungine sprays in the EU. This follows a review by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) which concluded that the benefits of fusafungine do 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).
Serious allergic reactions have occurred soon after the use of these sprays and involved bronchospasm (excessive and prolonged contractions of the airway muscles leading to difficulty breathing). Although the review found that serious allergic reactions are rare, they can be life-threatening and no measures have been identified to sufficiently reduce or manage this risk.
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