PRAC: Take Fusafungine Nose/Mouth Sprays Off Market in EU

Megan Brooks


February 12, 2016

Nasal and mouth sprays containing fusafungine should be taken off the market in the European Union (EU), the European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) recommended today.

Fusafungine is an antibacterial and anti-inflammatory agent used to treat infections in the upper airways, including sinusitis, tonsillitis, and laryngitis.

After reviewing fusafungine, the PRAC has concluded that the benefits of fusafungine do not outweigh its risks, particularly the risk for serious allergic reactions, according to an EMA statement.

As previously reported by Medscape Medical News, the PRAC review was initiated in September 2015 at the request of the Italian Medicines Agency, based on an uptick in reports of serious allergic reactions, including anaphylactic reactions, with fusafungine. Most of the serious allergic reactions were bronchospastic reactions, which occurred in both adults and children soon after the use of fusafungine-containing sprays.

The Italian Medicines Agency also had concerns about the benefit of fusafungine and its potential role in promoting antibiotic resistance, and therefore asked the EMA take a second look at the benefit–risk balance for fusafungine-containing medicines.

In the EU, fusafungine-containing medicines are currently marketed under the trade names Bioparox (Servier), Fusaloyos (Danval), Locabiotal (Servier), and Locabiosol (STADA).

"Although the PRAC review found that serious allergic reactions are rare, they can be life-threatening, and the PRAC considered that no measures had been identified to sufficiently reduce this risk. With regard to the benefits, the PRAC considered that the evidence for beneficial effects of fusafungine is weak," the EMA said today.

Given the mild and self-limited nature of upper airway diseases such as rhinopharyngitis, the PRAC concluded that the benefits of fusafungine did not outweigh the risks, the agency notes.

The PRAC found "insufficient" evidence to draw conclusions about fusafungine's role in promoting antibiotic resistance, but said this risk could not be excluded. "The PRAC therefore concluded that the benefit–risk balance for fusafungine-containing medicines is negative for all currently authorized uses and recommended that their marketing authorization be revoked in the European Union," the EMA said.

The PRAC recommendation will now be sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures–Human (CMDh), which will adopt a final position.

The EMA notes that marketing authorization of fusafungine-containing medicines have not yet been revoked and the medicines will remain available while a final decision is pending. "Further details including advice for patients and healthcare professionals will be published at the time of the CMDh position," the EMA said.


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