Regulatory Focus™ > News Articles > EMA Recommends Limiting Indication of Cilostazol-Containing Medicines Because of Risks

EMA Recommends Limiting Indication of Cilostazol-Containing Medicines Because of Risks

Posted 25 March 2013 | By Alexander Gaffney, RAC

A warning issued by the European Medicines Agency (EMA) on 22 March 2013 cautions healthcare providers and the public not to use cilostazol-containing medicines to treat intermittent claudication, a condition in which poor blood flow to the legs results in pain and difficulty walking, due to the heightened risks of serious bleeding and adverse cardiovascular events.

EMA-approved medicines containing cilostazol include Pletal and Ekistol, both phosphodiesterase type 3 inhibitors used to widen blood vessels to increase blood flow in patients. EMA said that while the medicines provide a "modest benefit to patients," those benefits were outweighed by a more complete understanding of the product's risks, which were recently evaluated by EMA's Committee on Medicinal Products for Human Use (CHMP).

"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," EMA explained. "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."

The review of the medication was prompted by a request from the Spanish Agency for Medicines and Health Products (AEMPS), which reportedly became concerned after receiving a number of serious adverse event reports detailing bleeding and cardiovascular events in patients receiving the drugs.

The opinion is now being sent to the European Commission (EC) for an EU-wide binding decision, which would limit the drugs' indications based on the new information.

Patients were advised to review their current course of treatment during their next routine appointment, and were not told to cease using the drug before then.


Tags: CHMP, EU

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