EMA calls for curbs on trimetazidine-containing and tolperisone medicines

The European Medicines Agency on Friday recommended restricting the use of trimetazidine-containing medicines in the treatment of patients with angina pectoris to second-line, add-on therapy. For all other indications the Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of these medicines were not sufficiently demonstrated and did not outweigh their risks. The CHMP therefore recommended their deletion from the marketing authorization.

There is no need for an urgent change in treatment, the EMA says, but adds that doctors should review their patients’ treatment at their next routine appointment. Doctors should no longer prescribe trimetazidine for the treatment of patients with tinnitus, vertigo or disturbances in vision. Patients who are taking trimetazidine in these indications should discuss alternatives with their doctor.

Doctors can continue to prescribe trimetazidine - the active ingredient of French drugmaker Servier’s Vestrel - for the treatment of angina pectoris, but only as an add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line anti-anginal therapies.