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A toll-free number was set up to rebadure the approximately 1.3 million patients concerned, nearly half of the patients treated with this molecule.
Le Monde
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• Updated
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By Pascale Santi
Valsartan-based medicinal products used in cases of heart failure, arterial hypertension and after recent cardiac infarction have is recalled in early July, worldwide, due to the presence of an undesirable substance detected in the active substance manufactured at the Chinese manufacturer. This impurity is N-nitrosodimethylamine (NDMA), a substance clbadified by the World Health Organization (WHO) as probably carcinogenic to humans. A substance that is also found in the air, water, certain foods …
The lots concerned by this quality defect have not been marketed since the end of June. The defect was reported by the European Medicines Agency (EMA). In France about 1.3 million patients are concerned, nearly half of the patients treated with this molecule. The National Agency for Drug Safety (ANSM) announced, Tuesday, July 24, in a statement, the establishment of a toll-free number 0-800-97-14-03 "to answer questions from patients or their entourage, available for free from Monday to Friday from 9 am to 7 pm ". The agency also posted information documents
Quality deficiency of certain #valsartan-based medicines: what steps should be followed for the patients concerned? … https://t.co/f9MCbMz5EQ
Immediate risk in case of abrupt discontinuation of the drug
"The important message is that there is no acute immediate risk to the health of patients, but the judgment Immediate treatment represents an immediate risk " told AFP the deputy general director of the ANSM, Christelle Ratignier-Carbonneil. The risk of abrupt cessation of treatment is real (hypertensive attacks, cardiac decompensations, neurological accidents), insists the ANSM. Also, patients should not stop it on their own. In case of doubt, patients should contact their pharmacist or doctor, who has received a letter.
This withdrawal of products from pharmacies concerns about half of valsartan medications. Nine laboratories are concerned (Arrow Generics, Biogaran, Cristers, Labo EG, Evolupharm, Ranbaxy Pharmacy Generics, Sandoz, Zentiva and Zydus), says the Agency. Other specialties containing valsartan or other medicinal products of the same therapeutic clbad are not concerned
The production of the active substance has been discontinued by the Chinese manufacturer. An investigation is underway at European level. This impurity, which was not detected during routine testing, is believed to be related to the change in the manufacturing process.
Research is ongoing to find out if it is found in tablets. The problem would be dated 2012. In order to prevent shortages, discussions are ongoing with laboratories that manufacture drugs based valsartan, not affected by this defect, including generics.
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