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A manufacturing defect on certain batches of trandolapril 2 mg and 4 mg is leading to a recall and supply tensions for this medication, indicated in cases of hypertension or in secondary post-infarction prevention. Find out what to do if you are concerned.
Don’t panic! If you are being treated with trandolapril, do not interrupt your treatment. Consult your doctor promptly so that he can prescribe an alternative.
Trandolapril: Defect detected, batches recalled
The Viatris and Biogaran laboratories have detected a variation in the active substance content in certain trandolapril 2 mg and 4 mg capsules. This defect led to the recall of the batches concerned and caused supply tensions. Fortunately, 0.5 mg versions, such as Odrik and Trandolapril Biogaran 0.5 mg, are not affected by this problem, but their availability remains insufficient to cover total demand.
To date, no pharmacovigilance cases linked to this quality defect have been reported. However, it is important not to stop or change your treatment without consulting your doctor. The risk of side effects is very low, but abruptly stopping treatment can lead to serious complications.
What should patients and doctors do?
If you are affected by this recall, the priority is to consult your doctor. He may prescribe you a therapeutic alternative, for example another ACE inhibitor (ACE inhibitor) or an angiotensin II receptor antagonist (Sartan). Do not stop your treatment without medical advice, as this could be much riskier than the manufacturing defect itself.
Pharmacists are invited to return defective batches and inform their patients. As for doctors, they should avoid prescribing the affected trandolapril 2 mg and 4 mg and turn to alternative medications.
An impact on the management of hypertension and post-infarctions
Trandolapril is mainly used in the treatment of high blood pressure and to prevent recurrence of myocardial infarction in patients with left ventricular dysfunction. The detected defect could lead to a risk of underdosing or overdosing, which requires careful medical monitoring.
Alternatives exist, and if you are post-infarction, other ACE inhibitors, such as ramipril or captopril, may be prescribed to you. In any case, remember to schedule a follow-up visit with your doctor to check the effectiveness of your new treatment.
Information for patients
The anti-hypertensives Trandolapril 2 mg and 4 mg Biogaran and Viatris are subject to supply constraints due to a quality defect detected in certain batches. This quality defect results in a variable content of trandolapril, which can lead to a risk of underdosing or overdose. The probability of occurrence of an adverse effect linked to this quality defect is very low compared to the risk of abrupt cessation of treatment.
If you are being treated with trandolapril (Trandolapril Viatris, Trandolapril Biogaran or Odrik):
- Do not interrupt your treatment;
- Contact your doctor now: he or she will prescribe an equivalent medication if necessary so that your treatment is not interrupted under any circumstances.
If you experience symptoms suggestive of hypertension, such as headache, shortness of breath, dizziness, etc. :
- We invite you to consult your doctor.
We invite you to also make a declaration on the reporting portal.