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Several dozen valsartan drugs were withdrawn from the market at the beginning of July because of the presence of traces of a potentially dangerous molecule.
At the beginning of July, several drugs based on valsartan has been recalled globally due to the presence of an impurity. The production of valsartan by the Chinese manufacturer has been stopped, and drugs containing this active substance that are marketed in France were quarantined at the end of June. An investigation is underway at European level. Approximately 1.3 million French people are taking a valsartan specialty to treat heart failure, high blood pressure or after recent infarction.
What is this quality defect? This is the presence of an impurity in the active ingredient, valsartan therefore, manufactured by the Chinese company Zhejiang Huahai Pharmaceuticals. This impurity is N – itrosodimethylamine (NDMA), a substance clbadified as probably carcinogenic to humans. It is the European Medicines Agency (EMA) which, first, reported this anomaly whose origin dates back to 2012, according to the French Agency for Medicines (ANSM). About half of valsartan medications are concerned. These are those made by the Arrow Generics laboratories, Biogaran, Cristers, EG Labo, Evolupharm, Ranbaxy Generic Pharmacy, Sandoz, Zentiva and Zydus.
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Not to stop treatment
Other proprietary medicinal products containing valsartan or other drugs of the same therapeutic clbad are not currently concerned and remain available. Some are subject to stockouts (those produced by Arrow Generics and Ranbaxy), but the national needs remain well covered despite everything, said the Agence du médicament.
What will happen now for patients taking any of these medications? "During a forthcoming delivery, the pharmacist will propose one of the valsartan specialties not affected by this defect," says the ANSM in a statement. Tuesday, the latter has set up a toll free number, the 0800 97 14 03, to answer questions from patients and their entourage. "This toll free number is available from Monday to Friday from 9am to 7pm," she said. Information documents as well as the complete list of impacted medicines were made public on Tuesday.
"The important message is that there is no immediate risk, acute health for patients (who take the drugs concerned, ed). On the other hand, immediate cessation of treatment represents an immediate risk, "ANSM Deputy Director General Christelle Ratignier-Carbonneil told AFP.
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