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On Thursday, the French Medicines Agency (ANSM) announced new drug recalls based on valsartan in France because of the presence of a substance clbadified as probably carcinogenic. These recalls will lead to stockouts after a first wave of recalls in early July.
In total, the sum of the two recalls is three-quarters of these drugs used in heart failure, high blood pressure and after recent cardiac infarction. Between 1.2 and 1.5 million patients in France follow this treatment.
A first reminder in July
The first international recall, involving nine brands, was motivated by the presence of an impurity, N-nitrosodimethylamine (NDMA), a substance clbadified as probably carcinogenic to humans. The Chinese company Zhejiang Huahai Pharmaceuticals was initially questioned, before two other Chinese laboratories, Rundu Pharma and Tianyu Pharm, were in turn pinned. All these companies manufacture the active ingredient on behalf of laboratories that then produce the drug.
The second recall, announced on Thursday, was decided because of "
the possible presence of another impurity, NDEA (N-nitrosodiethylamine)
". Of a nature close to the first, this impurity is, like her, "
clbadified as probably carcinogenic to humans by the World Health Organization (WHO)
", The ANSM said in a statement.
Move towards other treatments
This second undesirable substance
has been highlighted following the numerous investigations undertaken since July at the European level concerning valsartan
". Manufacturers of drugs that are not affected by the two recalls "
not
e are not currently able to increase their production enough to cover all the needs of French patients
". Therefore, "
substantial stock-outs are expected quickly
".
The ANSM advises patients to consult their doctor or pharmacist to find out if the medicine they are taking is concerned by the booster and, if necessary, move to another treatment.
"
As the risk of abrupt cessation of treatment is high (hypertensive attacks, cardiac decompensation, neurological accidents), patients should not under any circumstances interrupt their treatment without medical advice.
"Insists the drug agency, which set up in July a toll-free number: 0800 97 14 03.
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