Cilostazol-containing medicines

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

Overview

European Medicines Agency recommends restricting use of cilostazol-containing medicines

On 22 March 2013, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended that the use of cilostazol-containing medicines in the treatment of intermittent claudication – a condition where poor blood supply to the leg muscles causes pain and affects the ability to walk – should be restricted with a range of new measures aimed at targeting a patient population in which there are clinical benefits, and at the same time minimising important risks.

The recommendations followed a review of current evidence, which indicated that the modest benefits of these medicines, i.e. their ability to increase the distance patients are able to walk, are only greater than their risks, in particular the risks of side effects affecting the heart or serious bleeding, in a limited subgroup of patients.

Cilostazol-containing medicines are available in the European Union (EU) under the names Pletal and Ekistol.

The Committee recommended that cilostazol should only be used in patients whose symptoms have not improved despite prior lifestyle changes such as exercise, healthy diet and stopping smoking. In addition, cilostazol-containing medicines should not be used in patients who have suffered severe tachyarrhythmia (fast, abnormal heart rhythm), or recent unstable angina, heart attack or bypass surgery, or who take two or more antiplatelet or anticoagulant medicines such as aspirin and clopidogrel.

Doctors should review their patients at their next routine appointment and assess the continued suitability of cilostazol treatment.

Detailed recommendations for patients and healthcare professionals are available below.

The Spanish Agency for Medicines and Health Products (AEMPS) asked the CHMP to carry out a review of these medicines following a number of reports of serious suspected side effects, in particular affecting the heart, as well as cases of serious bleeding.

The CHMP examined available clinical-trial data on the benefits and risks of the medicines provided by the companies that market these medicines, as well as data from scientific literature, reports of suspected side effects, post-marketing studies and experimental studies before making its recommendations. More information on the studies and the CHMP's conclusions is available below.

The CHMP recommendation was sent to the European Commission, which endorsed it and adopted a legally-binding decision throughout the EU on 24 June 2013.

Key facts

About this medicine
Approved name
Cilostazol-containing medicines
International non-proprietary name (INN) or common name
cilostazol
Associated names
  • Pletal
  • Ekistol
Class
antiplatelet agents
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-31/1306
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.

Key dates and outcomes
CHMP opinion date
21/03/2013
EC decision date
24/06/2013

All documents

Opinion provided by Committee for Medicinal Products for Human Use

European Commission final decision

  • List item

    Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines (PDF/93.75 KB)


    First published: 11/09/2013
    Last updated: 11/09/2013
    EMA/423411/2013

  • List item

    Cilostazol-containing medicines - Article-31 referral - Annex II (cilostazol) (PDF/86.33 KB)


    First published: 11/09/2013
    Last updated: 11/09/2013

  • List item

    Cilostazol-containing medicines - Article-31 referral - Annex III (cilostazol) (PDF/383.94 KB)


    First published: 11/09/2013
    Last updated: 11/09/2013

  • List item

    Cilostazol-containing medicines - Article-31 referral - Annex IV (cilostazol) (PDF/55.58 KB)


    First published: 11/09/2013
    Last updated: 11/09/2013

  • List item

    Assessment report for cilostazol-containing medicinal products (PDF/482.05 KB)

    Adopted

    First published: 11/09/2013
    Last updated: 11/09/2013
    EMA/CHMP/428525/2013

  • List item

    Cilostazol-containing medicines - Article-31 referral - Annex I (cilostazol) (PDF/92.46 KB)


    First published: 11/09/2013
    Last updated: 11/09/2013

  • 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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