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PRAC recommends that fusafungine nose and mouth sprays are no longer marketed. Committee had concerns over serious allergic reactions and limited evidence of benefit

Notice type: 3rd Party Publications

Date: 12/02/2016

  

Product name or type:
Fusafungine-containing medicines

Problem Or Issue:
 EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that the marketing authorisation for fusafungine-containing medicines be revoked, so the medicines can no longer be marketed in the EU.  This follows a review by the 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-inflamatory nose and mouth spray used to treat upper airway infections such as rhinopharyngitis (common cold).

The PRAC recommendation will be considered by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which will adopt a final position.  HPRA will be contacting Healthcare Professionals in due course.

Background Information Or Related Documents:
PRAC Recommendation for fusafungine-containing medicines can be seen here

Further Information:
For full EMA statement please see here

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