Regulators in the EU have restricted the use of Otsuka Pharmaceutical’s Pletal after a review of current evidence indicated the drug’s benefits in patients with a blood supply disorder did not outweigh the risks.
The European Medicines Agency (EMA) said that cilostazol-containing medicines, such as Pletal, should only be used in patients with intermittent claudication whose symptoms have not improved despite lifestyle changes and who do not live with certain heart conditions.
This is because the “modest” benefits provided by cilostazol, such as increasing the distance a patient is able to walk, were only greater than its associated bleeding and heart risk when used in this limited subgroup.
Intermittent claudication is a condition where poor blood supply to the leg muscles causes pain and affects the ability to walk.
The EMA’s new recommendation means patients with the condition will only have access to Pletal if they still experience symptoms once they have made efforts to increase exercise, commit to a healthy a diet and to stop smoking, if applicable.
In addition, the EMA also restricted the use of cilostazol-containing medicines in patients with certain heart conditions such as severe tachyarrhythmia , recent unstable angina and heart, as well individuals with intermittent claudication who have undergone heart attack or bypass surgery.
The medicine is also recommended to be contraindicated in patients who take two or more antiplatelet or anticoagulant medicines, such as aspirin and clopidogrel.
According to the EMA: “Doctors should review their patients at their next routine appointment and assess the continued suitability of cilostazol treatment.”
Dr Giuseppe Di Benedetto, senior VP medical affairs and compliance at Otsuka commented on the restricted use of Pletal, which is known as Pletaal and Ekistol in certain countries.
He said: “Otsuka has worked in collaboration with the EMA in the review of the benefits and risks of cilostazol.
“We endorse the CHMP recommendation which has identified a more restricted target population in the approved indication in Europe, for whom the balance of benefits and risks is positive.”