European Medicines Agency recommends restricting use of cilostazol-containing medicines
The European Medicines Agency’s Committee on Medicinal Products for Human Use (CHMP) has 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 follow a review of current evidence which indicates 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 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 will now be sent to the European Commission for the adoption of a legally-binding decision throughout the European Union (EU).
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