Reactions 1446 - 6 Apr 2013

CHMP recommends restricting useof cilostazol

The EMA’s CHMP is recommending restricting theuse of cilostazol-containing medicines [Pletal, Ekistol],as it believes that the benefits only outweigh the risks –particularly the risks of serious bleeding and side effectsaffecting the heart – in a limited subgroup of patients.

Cilostazol-containing medicines are used in thetreatment of claudication, a condition where poor bloodsupply to the leg muscles causes pain and affects theability to walk. The Spanish Agency for Medicines andHealth Products (AEMPS) asked the CHMP to reviewthese medicines after a number of reports of serioussuspected side effects, particularly cardiac disorders andcases of serious bleeding.

Current evidence indicates that these medicines haveonly modest benefits in terms of improving patients’ability to walk. The CHMP is recommending thatcilostazol should only be used in patients whosesymptoms have not improved despite prior lifestylechanges such as smoking cessation, exercise andimproved diet. The committee is also recommendingthat these medicines not be used in patients who have ahistory of severe tachyarrhythmia, ore recent unstableangina, myocardial infarction or bypass surgery, orpatients taking two or more antiplatelet or anticoagulantmedicines.EMA. European Medicines Agency recommends restricting use of cilostazol-containing medicines. Media Release : [4 pages], 22 Mar 2013. Available from:URL: http://www.ema.europa.eu 803085352

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Reactions 6 Apr 2013 No. 14460114-9954/10/1446-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved