In a recent press release, the Anational drug safety agency (Ansm) informed of supply tensions in trandolapril (Biogaran, Viatris, Odrik), a drug indicated in the treatment of arterial hypertension and in secondary prevention post-myocardial infarction in patients with left ventricular dysfunction. It suggests a course of action to best take care of patients.
It is a variation in the active substance content in certain Trandolapril 2 mg and 4 mg capsules which may lead to a risk of underdosing or overdosing in patients which is the cause of a batch recall leading to drug tensions. ‘supply.
In terms of safety, “no case of pharmacovigilance linked to this quality defect has been reported to the laboratory to date”, indicates the agency which adds that “the probability of occurrence of an adverse effect linked to this defect quality is very low compared to the risk of abrupt cessation of treatment.
Note that the specialties Odrik and Trandolapril 0.5 mg Biogaran are not affected by this defect and remain available “but in insufficient quantities to cover all needs”.
In practice
Faced with this shortage of Trandolapril 2 mg and 4 mg, the Ansm, in consultation with representatives of health professionals, has developed a course of action.
The agency recommends that doctors no longer initiate treatment with these specialties and reserve the prescription of Odrik and Trandolapril Biogaran 0.5 mg for post-MI patients with heart failure with reduced ejection fraction who are likely to experience poorer health. tolerate a change in treatment.
Failing this, another IEC may be prescribed. The ACE inhibitors with an indication in secondary prevention after myocardial infarction are ramipril and captopril.
For patients treated for hypertension, the Ansm recommends prescribing as an alternative, “another inhibitor of the renin angiotensin system and scheduling a follow-up visit within a reasonable time after the change in treatment in order to monitor effectiveness and tolerance. of the new treatment.
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