The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that the marketing authorisation for 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).
The majority of the serious allergic reactions occurred soon after the use of the medicine and involved bronchospasm (excessive and prolonged contractions of the airway muscles leading to difficulty breathing).
Although the PRAC review found that serious allergic reactions are rare, they can be life-threatening, and PRAC considered that no measures had been identified to sufficiently reduce this risk.
With regard to the benefits, PRAC considered that the evidence for beneficial effects of fusafungine is weak.
PRAC was 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).
Although the evidence was insufficient to conclude on the risk of resistance, this risk could not be excluded.
Fusafungine-containing medicines have been available in a number of EU countries for over 50 years.
They have been authorised through national approval procedures. They are currently marketed under various trade names (Bioparox, Fusaloyos, Locabiotal and Locabiosol) in the following countries: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Portugal, Romania, Slovakia and Spain.