Fusafungine-containing medicines should be withdrawn, says European Medicines Agency
Nasal and mouth sprays containing fusafungine for treating the common cold, tonsillitis and some upper respiratory tract infections should no longer be marketed in the European Union because of the risk of potentially fatal allergic reactions, according to a recommendation from the European Medicines Agency (EMA).
A safety review of fusafungine, an anti-inflammatory and antibiotic medicine, concluded that its risks — although rare — outweighed its benefits.
The review, by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), found that the majority of serious reactions, which involved excessive and prolonged contractions of the airway muscles leading to breathing difficulties, occurred soon after the medicine was used.
The PRAC’s recommendation also takes into account its concern that the product has the potential to promote antibiotic resistance.
Fusafungine-containing sprays are currently licensed for use in Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Estonia, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Portugal, Romania, Slovakia and Spain. They have never been approved for use in the UK.
The PRAC recommendation now faces the EMA’s Co-ordination Group for Mutual Recognition and Decentralised Procedures for final approval.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2016.20200711
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