Updated on 25 March 2013
EMA recommends restricting use of cilostazol-containing medicines
Singapore: 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 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.
Intermittent claudication is a condition where poor blood supply to the leg muscles causes pain and affects the ability to walk. Cilostazol-containing medicines are available in the EU under the names Pletal and Ekistol.
The recommendations follow a review of current evidence, which indicates that the modest benefits of these medicines, ie 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.
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.