Other safety alerts
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| European Union: European Medicines Agency recommends restricting use of trimetazidine-containing medicines for patients with stable angina pectoris |
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The European Medicines Agency has 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 (treatment of vertigo, tinnitus and vision disturbance), 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 the risks. The CHMP therefore recommended their deletion from the marketing authorisation. The EMA recommends:-
There is no need for an urgent change in treatment, but 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 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.
The review was initiated by France, mainly because of concerns that the efficacy of trimetazidine was not sufficiently demonstrated. It also looked at reports regarding the occurrence of movement disorders such as Parkinsonian symptoms, restless leg syndrome, tremors and gait instability associated with the medicine. Although patients usually recovered fully within four months after treatment with trimetazidine was discontinued, the Committee recommended new contraindications and warnings to reduce and manage the possible risk of movement disorders associated with the use of this medicine, which includes:-
Doctors are advised not to prescribe the medicine to patients with Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome orother related movement disorders, nor to patients with severe renal impairment.
Doctors should exercise caution when prescribing trimetazidine to patients with moderate renal impairment and to elderly patients, and consider dose reduction in these patients.
Trimetazidine should be discontinued permanently in patients who develop movement disorders such as Parkinsonian symptoms. If Parkinsonian symptoms persist for more than four months after discontinuation, a neurologist’s opinion should be sought.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_001541.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are 7 registered pharmaceutical products containing trimetazidine and are prescription-only medicines. In view of the EMA's recommendation, a letter to inform healthcare professionals will be issued and the matter will be discussed in the meeting of Registration Committee of the Pharmacy and Poisons Board.
Ends/ Monday, June 25, 2012
Issued at HKT 14:00
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