Inhaled corticosteroids containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease

  • Procedure started
  • Under evaluation
  • PRAC recommendation
  • CHMP opinion
  • European Commission final decision
Current status
European Commission final decision

Overview

 

EMA completes review of inhaled corticosteroids for chronic obstructive pulmonary disease

Review finds no differences between products in risk of pneumonia

On 28 April 2016 EMA completed a review of the known risk of pneumonia (lung infection) in patients who take inhaled corticosteroid medicines to treat chronic obstructive pulmonary disease (COPD). COPD is a long-term disease of the lungs in which the airways and air sacs in the lungs become damaged or blocked, leading to breathing difficulties. Corticosteroid inhalers are widely used in the European Union (EU) to treat COPD and pneumonia is a common side effect of such treatment.

The review confirmed the risk of pneumonia with these products, which has been known for many years, and that it is common (can affect between 1 and 10 COPD patients in 100 using these medicines). The review did not find any conclusive evidence of differences in this risk for different products.

Overall the benefits of inhaled corticosteroid medicines in treating COPD continue to outweigh their risks and there should be no change to the way in which these medicines are used. Patients with COPD and their doctors should however be alert for signs and symptoms of pneumonia, bearing in mind that the clinical features of pneumonia overlap with those of a worsening (exacerbation) of the underlying disease.

The review was carried out by the Agency's Pharmacovigilance Risk Assessment Committee (PRAC), which recommended that the product information for these medicines should be updated to adequately reflect current knowledge about the risks. The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), which adopted the Agency's opinion. The CHMP's opinion was then sent to the European Commission, which issued a final legally-binding decision valid throughout the EU.

Key facts

About this medicine
Approved name
Inhaled corticosteroids containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease
International non-proprietary name (INN) or common name
  • beclometasone
  • budesonide
  • flunisolide
  • fluticasone propionate
  • fluticasone furoate
Class
-
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-31/1415
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
Centrally and nationally authorised products (mixed)
Decision making model
PRAC-CHMP-EC
Key dates and outcomes
Procedure start date
07/05/2015
PRAC recommendation date
17/03/2016
CHMP opinion/CMDh position date
28/04/2016
EC decision date
29/06/2016
Outcome
Variation

All documents

Procedure started

Recommendation provided by Pharmacovigilance Risk Assessment Committee

Opinion provided by Committee for Medicinal Products for Human Use

European Commission final decision

  • List item

    Inhaled corticosteroids Article-31 referral – EMA completes review of inhaled corticosteroids for chronic obstructive pulmonary disease (PDF/87.66 KB)


    First published: 15/07/2016
    Last updated: 15/07/2016
    EMA/488280/2016

  • List item

    Inhaled corticosteroids Article-31 referral – PRAC assessment report (PDF/228.27 KB)


    First published: 15/07/2016
    Last updated: 15/07/2016
    EMA/330021/2016

  • List item

    Inhaled corticosteroids Article-31 referral – EMA completes review of inhaled corticosteroids for chronic obstructive pulmonary disease (PDF/87.66 KB)


    First published: 15/07/2016
    Last updated: 15/07/2016
    EMA/488280/2016

  • List item

    Inhaled corticosteroids Article-31 referral – Annex II (PDF/43.42 KB)


    First published: 15/07/2016
    Last updated: 15/07/2016

  • List item

    Inhaled corticosteroids Article-31 referral – Annex III (PDF/38.4 KB)


    First published: 29/04/2016
    Last updated: 15/07/2016

  • List item

    Inhaled corticosteroids Article-31 referral – Annex I (PDF/815.13 KB)


    First published: 19/05/2015
    Last updated: 15/07/2016

  • 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.

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