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A toll-free number was set up by the ANSM on Tuesday, July 24, by the Agence du médicament after the precautionary recall in early July of certain drugs based on valsartan.
Some of these drugs, used in cases of heart failure, high blood pressure and after a recent cardiac infarction, were the subject of a global recall at the beginning of July. At issue: the presence of an undesirable substance detected in the Chinese manufacturer.
The ANSM has set up a toll free number, the 0 800 97 14 03 free of charge from Monday to Friday from 9am to 19h. Information documents and the list of medications concerned and those that are not, are available online on the ANSM website.
Failure of quality of certain drugs based #valsartan : what approach to follow for the patients concerned? Consult the information document for patients. A toll-free number is also available
▶ ️ More information at: https://t.co/Qxd6VRLZMp pic.twitter.com/A9tLgiLTbP– ANSM (@ansm) ] July 24, 2018
Talk to your doctor before stopping treatment
The most important thing is to stop treatment in any case. If you take a medicine that you are concerned with, you should talk to your doctor or pharmacist, who will replace you with another one that is not.
"The important message is is that there is no immediate risk, acute for the health of patients (who take the drugs concerned, ed), however the immediate cessation of treatment represents an immediate risk " explained the Director General badistant of ANSM, Christelle Ratignier-Carbonneil
"No immediate risk"
About 1.3 million patients are concerned, nearly half of the patients treated in France with this molecule.
This measure of withdrawal of products in pharmacies concerns about half of valsartan medicines. Nine laboratories are concerned (Arrow Generics, Biogaran, Cristers, Labo EG, Evolupharm, Ranbaxy Pharmacy Generics, Sandoz, Zentiva and Zydus).
A defect of quality because of the Chinese manufacturer
The anomaly was reported by the European Medicines Agency (EMA), and has led to recall measures at international level
The quality defect detected is the presence of an impurity in the active substance manufactured by the Chinese company Zhejiang Huahai Pharmaceuticals. This impurity is N-nitrosodimethylamine (NDMA), a substance clbadified as probably carcinogenic in humans.
The production of the active substance of this company has been stopped and an investigation is underway at European level.
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