Trimetazidine has been in the spotlight for several months. This drug, indicated ” in the adjunctive treatment of reduced acuity and visual field disturbances of vascular origin, in the adjunct symptomatic treatment of dizziness and tinnitus, and in the prophylactic treatment of angina pectoris ” indeed appears in the list of 77 drugs placed under special surveillance at the beginning of the year by Afssaps.
In addition, last April, after being alerted to undesirable neurological effects (balance disorders, tremors, parkinsonian syndromes, etc.), the Marketing Authorization Commission of the French Product Health Safety Agency de santé has requested the suspension of the Marketing Authorization for Vastarel and all its generic versions. The Commission then re-examined the benefit / risk ratio of the medicinal product in its indications and concluded “ that there was no proven benefit at the present time in the three indications “.
Responsible for arbitrating this decision, the European Medicines Agency, in turn, recommended the deletion of two indications out of the three which had until now been recognized for trimetazidine. Only one indication is maintained and modified: that of the symptomatic treatment of angina, provided that the drug is prescribed as second-line and in combination in insufficiently controlled patients. The European Medicines Agency therefore recommends “to patients who receive trimetazidine for tinnitus, dizziness or vision problems ”, to consult their doctor without emergency, so that another treatment can be offered to them.
Remember that Vastarel has been marketed in France since 1978 but has not been reimbursed by Health Insurance since March 2012.
