Reactions 1446 - 6 Apr 2013 CHMP recommends restricting use of cilostazol The EMA’s CHMP is recommending restricting the use of cilostazol-containing medicines [Pletal, Ekistol], as it believes that the benefits only outweigh the risks – particularly the risks of serious bleeding and side effects affecting the heart – in a limited subgroup of patients. Cilostazol-containing medicines are used in the treatment of claudication, a condition where poor blood supply to the leg muscles causes pain and affects the ability to walk. The Spanish Agency for Medicines and Health Products (AEMPS) asked the CHMP to review these medicines after a number of reports of serious suspected side effects, particularly cardiac disorders and cases of serious bleeding. Current evidence indicates that these medicines have only modest benefits in terms of improving patients’ ability to walk. The CHMP is recommending that cilostazol should only be used in patients whose symptoms have not improved despite prior lifestyle changes such as smoking cessation, exercise and improved diet. The committee is also recommending that these medicines not be used in patients who have a history of severe tachyarrhythmia, ore recent unstable angina, myocardial infarction or bypass surgery, or patients taking two or more antiplatelet or anticoagulant medicines. 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 1 Reactions 6 Apr 2013 No. 1446 0114-9954/10/1446-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

CHMP recommends restricting use of cilostazol

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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