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Trimetazidine: unfavourable risk-benefit balance confirmed

Despite a markedly unfavourable risk-benefit balance, trimetazidine is still on the market in France for various situations.

Trimetazidine has been marketed in France since 1965 for various situations, ranging from angina to visual disorders, including vertigo and tinnitus, with no tangible clinical efficacy beyond a placebo effect.

A French pharmacovigilance study revealed more than 300 reported adverse effects of trimetazidine (in addition to known risks of thrombopenia and Parkinsonian syndromes).

Numerous organs are affected: decrease in the number of platelets and red cells, skin lesions, adverse cardiac effects, neuropsychological disorders, etc.

These newly reported adverse effects of trimetazidine confirm its unfavourable risk-benefit balance.

These sometimes severe adverse effects are all the more worrying since trimetazidine is prescribed mainly to elderly patients and some of these adverse effects increase the risk of falls. Furthermore, trimetazidine is eliminated by the kidneys, which carries a risk of accumulation in elderly patients.

When will the French health authorities make up their minds to withdraw a product that has no proven efficacy and whose adverse effects are numerous and sometimes severe?

©Prescrire May 2010

"Trimetazidine: new French pharmacovigilance data" Prescrire Int 2010; 19 (106): 74 (pdf, subscribers only).
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