This Thursday, the National Medicines Safety Agency (ANSM) announced a new recall of valsartan-based medicines. In question: the detection of a second probably carcinogenic substance.
The health scandal surrounding varsaltan since this summer has not ended. In early July, the National Medicines Safety Agency (ANSM) announced the recall of certain generic medicines based on valsartan, used to stabilize blood pressure and thus prevent the risk of stroke or myocardial infarction.
A second potentially carcinogenic substance detected
In question, according to the Medicines Agency: the presence in these drugs manufactured by the Chinese laboratories Zhejiang Huahai Pharmaceuticals, Rundu Pharma and Tianyu Pharm, of traces of N-nitrosodimethylamine (NDMA), a potentially carcinogenic substance.
This Thursday, November 29, a new recall was issued against varsaltan-based medicines. The ANSM justifies this new withdrawal from French pharmacies by the “possible presence of another impurity, NDEA (N-nitrosodiethylamine)”, also “classified as probably carcinogenic in humans by the World Health Organization ( WHO)”.
In his press release, the ANSM specifies that this second undesirable substance “has been highlighted following numerous investigations undertaken since July 2018 at European level concerning valsartan”. Other European and international states have also recalled the drugs concerned.
A high risk of out of stock
This precautionary measure will be followed by an immediate effect, warns the ANSM: that of the shortage of stocks of drugs based on valsartan. Indeed, by combining the two recalls carried out by the Medicines Agency, three-quarters of the stocks produced by eleven pharmaceutical laboratories (Arrow Generics, Biogaran, Cristers, EG Labo, Evolupharm, Mylan, Ranbaxy, Sandoz, Teva, Zentiva and Zydus) which are disappearing from pharmacies.
This could have serious health effects for people on treatment with valsartan. According to the ANSM, 1.2 to 1.5 million patients follow this treatment in France.
“The risk of a sudden cessation of treatment being significant (hypertensive flare-ups, cardiac decompensation, neurological accidents), patients should in no case interrupt their treatment without medical advice”, warns Jean-Michel Race, one of the directors of the ANSM medicines.
Joined last July by Why Doctor, Professor Jean-Jacques Mourad (AP-HP), specialist in hypertension, had the same speech: “It is crucial not to stop your treatment. Stopping can induce significant complications , such as flare-ups of heart failure or elevated blood pressure, including an increased risk of stroke.
The Agency recalls that there are alternatives to these treatments withdrawn from sale and recommends that the patients concerned consult their doctor or pharmacist without delay.
Quality defect of certain medicinal products #valsartan : what approach should be followed for the patients concerned? Consult the information document intended for patients. A toll-free number is also available.
?? More information on : https://t.co/Qxd6VRLZMp pic.twitter.com/A9tLgiLTbP—ANSM (@ansm) July 24, 2018
A toll-free number has also been made available to patients and their relatives by the ANSM: 0800 97 14 03. The list of medicines affected by the withdrawal is also available.
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