EMA 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, 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.

Medicines containing cilostazol have been approved in the European Union through national procedures since 2000 and are available in France, Germany, Italy, Spain, Sweden and the UK under the trade names Pletal (from Japan’s Otsuka Pharmaceuticals) and Ekistol (from Spanish drugmaker Lacer SA).