THE ESSENTIAL
- Lots of trandolapril are being recalled due to a manufacturing defect.
- This creates supply tensions: some patients no longer have access to the medicine.
- They must consult their treating physician quickly to find an alternative, without interrupting or modifying their treatment.
A simple error in the manufacture of a medicine can have serious consequences. Recently, Biogaran and Viatris laboratories reported a variation in the content of an active substance in certain batches of trandolapril. Capsules of this anti-hypertensive medication are recalled. In pharmacies, supply tensions appear due to insufficient stocks.
Supply tensions linked to a fault in the dosage
The drug is prescribed against high blood pressure, but also for secondary prevention post-myocardial infarction in patients with left ventricular dysfunction. The non-compliant batches identified by the laboratories only concern the 2 mg and 4 mg boxes. “Some have a very variable trandolapril content, which can lead to a risk of underdosing or overdosing in patients, explain the ANSM in a press release. (…) 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.”
Trandolapril: how to react if you are affected by supply tensions?
The ANSM has developed a “conduct to follow” for the patients concerned and healthcare professionals in order to limit the risk of incidents linked to these supply tensions. Patients treated with Trandolapril Viatris, Trandolapril Biogaran or Odrik should contact their GP as soon as possible. “If necessary, he will prescribe an equivalent medication so that your treatment is not interrupted under any circumstances.”she warns. For people with hypertension, other treatments from the renin-angiotensin system inhibitor family may be prescribed. For people taking trandolapril for prevention after a myocardial infarction, two other medications may be used: ramipril and captopril.
Hypertension: treatment should not be interrupted without medical advice
The ANSM insists on one point: patients must not interrupt their treatment suddenly, or even change it without the advice of a healthcare professional. The risks associated with abrupt termination of treatment are significant.
Furthermore, if you are still taking trandolapril and symptoms suggestive of hypertension, such as headache, shortness of breath or dizziness, appear, you should consult a doctor. “The probability of occurrence of an adverse effect linked to this quality defect is very low compared to the real risk in the event of abrupt cessation of treatment.however reassures the ANSM.
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