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Certain valsartan drugs are subject to a "booster" as a precaution. The presence of an impurity has been detected in their Chinese manufacturer, said Friday the
National Agency for Drug Security (ANSM). About 1.3 million people are concerned, almost a third of French patients treated with this molecule. Nine laboratories are involved. "There is no risk of acute toxicity. Patients must not stop
their treatment, "said Dominique Martin, head of the ANSM.
European level survey
Valsartan is prescribed in case of heart failure, arterial hypertension or after cardiac infarction. The anomaly was reported by the European Medicines Agency (EMA), prompting a collective and concerted recall of batches concerned by the Member States. An investigation into this quality defect is in progress at European level
The impurity in question is N-nitrosodimethylamine (NDMA), a substance clbadified as probably carcinogenic to humans. The productions of the active substance have been stopped. Medicines containing it and marketed in France have been quarantined by the laboratories at the end of June 2018.
The other valsartan or other medicinal products of the same therapeutic clbad are not concerned to this day and remain available, note l 'ANSM. During a forthcoming delivery, the pharmacist will propose a valsartan drug not affected by this defect to patients
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