Fusafungine containing medicinal products for oromucosal and nasal use - referral

Current status

CMDh final position

Overview

 

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Medicines to be withdrawn due to serious allergic reactions and limited evidence of benefit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.

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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.

Fusafungine Article-31 referral - CMDh endorses revocation of authorisations for fusafungine sprays used to treat airway infections

AdoptedReference Number: EMA/227560/2016

Key facts

About this medicine

• Approved name:
  Fusafungine containing medicinal products for oromucosal and nasal use
• International non-proprietary name (INN) or common name:
  fusafungine
• Class:
  -

About this procedure

• Current status:
  CMDh final position
• Reference number:
  EMEA/H/A-31/1420
• Type:
  Article 31 referrals

  This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

• Authorisation model:
  Nationally authorised product(s)
• Decision making model:
  PRAC-CMDh

Key dates and outcomes

• Procedure start date:
  10/09/2015
• PRAC recommendation date:
  11/02/2016
• CHMP opinion date:
  31/03/2016
• Outcome:
  Revocation

All documents

Procedure started

Fusafungine Article-31 referral - PRAC list of questions

Adopted

Fusafungine Article-31 referral - Timetable for the procedure

Fusafungine Article-31 referral - Review started

Fusafungine Article-31 referral - Notification

Fusafungine Article-31 referral - Annex I

Reference Number: EMA/323030/2015

Recommendation provided by Pharmacovigilance Risk Assessment Committee

Fusafungine Article-31 referral - PRAC recommends that fusafungine nose and mouth sprays are no longer marketed

Reference Number: EMA/91073/2016

Position provided by CMDh

Fusafungine Article-31 referral - Annex II

Fusafungine Article-31 referral - Annex I

Fusafungine Article-31 referral - Assessment report

AdoptedReference Number: EMA/194153/2016

Fusafungine Article-31 referral - Annex III

AdoptedReference Number: EMA/227560/2016

Fusafungine Article-31 referral - CMDh endorses revocation of authorisations for fusafungine sprays used to treat airway infections

AdoptedReference Number: EMA/227560/2016

Fusafungine Article-31 referral - CMDh endorses revocation of authorisations for fusafungine sprays used to treat airway infections

AdoptedReference Number: EMA/227560/2016

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

• Overview - lay-language summary of the stage of the procedure
• Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
• Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
• List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
• Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
• List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
• List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
• Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
• Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
• Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
• Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
• Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
• Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
• Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
• Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

Note that older documents may have different titles.