EU medicines agency to restrict use of Otsuka drug

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LONDON (Reuters) – The European Medicines Agency said on Friday it was recommending restricting the use of medicines containing cilostazol, sold by Otsuka under the brand name Pletal, following concerns over side effects.

A review of evidence found the drug’s modest benefit was only greater than its risk of damaging the heart or causing serious bleeding in a limited number of patients.

Cilostazol, also sold as Ekistol, is used for treatment of intermittent claudication, or limping, usually as a result of arterial disease.

The agency said cilostazol should only be used in patients whose symptoms had not improved despite lifestyle changes. It should also not be used in patients who have fast, abnormal heartbeats, or those with recent unstable angina, heart attack or bypass surgery, or who take two or more blood-thinning drugs.

(Reporting by Ben Hirschler- Editing by Helen Massy-Beresford)

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