CMDh endorses revocation of authorisations for fusafungine sprays used to treat airway infections
Medicines to be withdrawn due to serious allergic reactions and limited evidence of benefit
The CMDh1 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.
With regard to the benefits, the evidence for beneficial effects of fusafungine is weak. Taking into account the mild and self-limiting nature of upper airway infections such as rhinopharyngitis, the benefits of fusafungine were not considered to outweigh the risks.
In addition, there were concerns 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 there is insufficient evidence to establish that fusafungine can increase the risk of resistance, this risk could not be ruled out. The benefit-risk balance for fusafungine-containing medicines is therefore negative for all currently authorised uses.
Following the CMDh consensus position, EU Member States will start revoking the marketing authorisations of these medicines in their territories, according to an agreed timetable.
1 The CMDh is a medicines regulatory body representing the European Union (EU) Member States.
- Information for patients and healthcare professionals
- Fusafungine nose and mouth sprays have been used to treat upper airway infections.
- These sprays are being taken off the market in the EU because of rare cases of serious allergic reactions and the lack of strong evidence that these medicines work.
- Upper airway infections are usually mild and self-limiting.
- Healthcare professionals should advise patients on alternative treatments, if needed.
- Patients with any questions should speak to their healthcare professional.
- More about the medicine
Fusafungine is an antibiotic and anti-inflammatory medicine used in the form of a nasal and oromucosal (to be applied to the mouth) spray for the treatment of the following infections of the upper airways: sinusitis (sinus infection), rhinitis (stuffy and runny nose), rhinopharyngitis (common cold), tonsillitis (inflammation of the tonsils caused by an infection) and laryngitis (inflammation of the voice box).
Fusafungine-containing medicines have been available in several EU countries for over 50 years. They were authorised through national approval procedures under various trade names (Bioparox, Fusaloyos, Locabiotal and Locabiosol) in the following countries: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Portugal, Romania, Slovakia and Spain.
In some Member States, these medicines were available without prescription.
- More about the procedure
The review of fusafungine-containing medicines was initiated on 11 September 2015 at the request of Italy, under Article 31 of Directive 2001/83/EC.
The review has been carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations. During its review the PRAC consulted EMA’s paediatric scientific committee as well as experts in the field of anti-infective medicines.
As fusafungine-containing medicines are all authorised nationally, the PRAC recommendations were forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which adopted a final position on 31 March 2016.
The CMDh is a regulatory body representing EU Member States as well as Iceland, Liechtenstein and Norway. It is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
As the CMDh adopted its position by consensus, the measures recommended by the PRAC will be implemented directly by the Member States where the medicines are authorised, according to an agreed timetable.
About this medicine
|Approved name||Fusafungine containing medicinal products for oromucosal and nasal use|
|International non-proprietary name (INN) or common name|
About this procedure
|Current status||Position provided by CMDh|
|Type||Article 31 referrals|
This type of referral is triggered when the interest of the Community is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.
|Decision making model||PRAC-CMDh|
|Authorisation model||Nationally authorised product(s)|
Key dates and outcomes
|Procedure start date||10/09/2015|
|PRAC recommendation date||11/02/2016|
|CHMP opinion/CMDh position date||31/03/2016|
|Name||Language||First published||Last updated|
|Fusafungine Article-31 referral - PRAC list of questions||HR = Hrvatski||2015-09-11|
|Fusafungine Article-31 referral - Annex I||HR = Hrvatski||2015-09-11|
|Fusafungine Article-31 referral - Review started||HR = Hrvatski||2015-09-11|
|Fusafungine Article-31 referral - Timetable for the procedure||HR = Hrvatski||2015-09-11||2015-12-04|
|Fusafungine Article-31 referral - Notification||HR = Hrvatski||2015-09-11|
Recommendation provided by Pharmacovigilance Risk Assessment Committee
|Name||Language||First published||Last updated|
|Fusafungine Article-31 referral - PRAC recommends that fusafungine nose and mouth sprays are no longer marketed||HR = Hrvatski||2016-02-12|
Position provided by CMDh
- Annex I - List of the medicines affected by the referral
- Annex II - Scientific conclusions of the Committee for Medicinal Products for Human Use (CHMP) or Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh)
- Annex III - Changes to the summary of product characteristics, labelling or package leaflet - available when the CHMP or CMDh recommends changes to the product information. Also includes conditions for lifting of suspensions, if applicable
- Annex IV - Conditions of the marketing authorisation - available when the CHMP or CMDh recommends other measures to be taken for the marketing authorisation such as safety measures or additional studies
- Notification - A letter from a Member State, the European Commission or a marketing-authorisation holder requesting the initiation of a referral procedure
- Rationale for triggering - Background provided by the party triggering the referral explaining the issues leading to the initiation of the procedure
- PRAC list of questions - Questions agreed by the PRAC requesting further information to evaluate the issues identified
- PRAC timetable - Timeframe agreed by the PRAC to receive information, assess the issues and adopt a recommendation
- PRAC / CHMP / CMDh assessment report - The assessment and conclusions of the PRAC and CHMP or CMDh on the issues investigated