Medicines based on valsartan, used in heart failure and high blood pressure, have been recalled due to the possible presence of a carcinogenic substance with prolonged use. This defect could date from 2012.
The National Medicines Safety Agency (ANSM) warned Friday, July 6 on the recall of batches of generic drugs based on valsartan (or valsartan / hydrochlorothiazide), used in arterial hypertension and heart failure. The incriminated batches are no longer delivered on European territory, due to the possible presence of impurities. The United States and Canada have since followed suit with the European Union.
A long-standing fault?
The problem stems from one of the producers of valsartan, the Chinese giant Zhejiang Huahai Pharmaceutical. Due to a defect in the manufacturing process, some batches of valsartan may contain traces of N-nitrosodimethylamine (NDMA), a potentially carcinogenic substance upon prolonged exposure.
The European Medicines Agency (EMA) has launched an investigation to determine the origin of this quality defect. In a press release published Tuesday July 17th, the European regulator estimates that the manufacturing defect could date back to 2012, when the Chinese generic company modified its manufacturing process.
Do not interrupt your treatment
“NDMA is an unexpected impurity that had not been detected through routine tests carried out by Zhejiang Huahai,” said the EMA. The ongoing investigation should make it possible to know with certainty since when patients have been exposed to NDMA, and at what level of exposure.
The list of the fifty affected lots is available on the ANSM website. The agency recalls that there is “no acute risk for the patient”, NDMA being harmful only in the event of long-term exposure. On the other hand, it is not recommended to interrupt your treatment with valsartan, otherwise your cardiac risk will be greatly increased. Better to talk to your pharmacist or doctor if you want to change medication.
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