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Trimetazidine:
witholding information from patients

Trimetazidine has an unfavourable risk-benefit balance. Contrary to the information provided to health professionals, the patient information leaflet does not inform patients of the need to review the prescription after three months' treatment.

Trimetazidine has been on the market for more than 45 years in France, despite its unfavourable risk-benefit balance. Its efficacy has not been firmly established in its various therapeutic indications, which include cardiology (angina), ophthalmology (visual disorders), and neurology (dizziness, buzzing and whistling in the ears); and it exposes patients to the risk of Parkinsonian syndromes in particular.

In December 2007, information from the French health authorities on this drug was amended to include the following information: "the benefit of treatment should be reviewed after three months and trimetazidine should be halted if the patient is not responding".

Regrettably, this warning is not included on the patient information leaflet. The French drug regulatory agency (Afssaps) explains this is not specified because it is up to the doctor to supervise the halting of treatment. However this is vital information for patients, who are the people most concerned by the treatment.

Just who benefits from this lack of transparency over a drug with an unfavourable risk-benefit balance?

© Prescrire May 2008

Source: "Trimétazidine : rétention d'informations vis-à-vis des patients" Rev Prescrire 2008; 28 (295) 339.

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