[ad_1]
The withdrawal of drugs based valsartan takes a new dimension: after a first wave in early July, additional reminders were announced Thursday by the agency of drugs (ANSM), because of the presence of a second substance clbadified as probably carcinogen.
This precautionary measure will lead to stockouts, warned the ANSM.
Indeed, the combination of the two reminders affects three-quarters of these drugs used in cases of heart failure, high blood pressure and after a recent infarction. Between 1.2 and 1.5 million patients in France follow this treatment.
The first international recall was motivated by the presence of an impurity, N-nitrosodimethylamine (NDMA), a substance clbadified as probably carcinogenic to humans.
China's Zhejiang Huahai Pharmaceuticals was initially questioned. Two other Chinese laboratories, Rundu Pharma and Tianyu Pharm, were then pinned.
All these companies manufacture the active ingredient on behalf of laboratories that then produce the drug.
The second recall, announced Thursday, was decided because of "the possible presence of another impurity, the NDEA (N-nitrosodiethylamine)", according to the ANSM.
A nature similar to the first, this impurity is, like her, "clbadified as probably carcinogenic in humans by the World Health Organization (WHO)," said the ANSM in a statement.
This second undesirable substance "was highlighted following the numerous investigations undertaken since July 2018 at the European level concerning valsartan".
Like the first, this new reminder "is implemented by other European states and internationally", according to the ANSM.
In total, eleven pharmaceutical companies are concerned by the two recalls, which do not necessarily affect all the drugs based on valsartan they produce: Arrow Generics, Biogaran, Cristers, Labo EG, Evolupharm, Mylan, Ranbaxy, Sandoz, Teva , Zentiva and Zydus.
It is unclear whether the second impurity found in the drugs recalled Thursday is due to Chinese companies already pinned, or if new subcontractors are in turn blamed.
"For now, we can not answer this question.This is part of ongoing investigations" at the international level, told AFP one of the leaders of the ANSM, Jean-Michel Race.
Manufacturers of drugs that are not affected by the two recalls "are currently not able to increase their production enough to cover all the needs of French patients," said the ANSM. As a result, "large stockouts are expected quickly".
"There are many therapeutic alternatives to ensure optimum management of patients currently treated with valsartan," said the ANSM.
"Arterial hypertension is common and very well supported by practitioners," added Jean-Michel Race, according to which alternative solutions are "other sartans (a clbad of drugs whose valsartan is one of the variants , ed) and other families of antihypertensives ".
ANSM recommends that patients consult their doctor or pharmacist to find out if the medicine they are taking is concerned with the booster and, if necessary, to switch to another treatment.
"The risk of abrupt cessation of treatment being important (hypertensive outbreaks, cardiac decompensations, neurological accidents), patients should not under any circumstances interrupt their treatment without medical advice", insisted the ANSM.
"Stopping treatment when you are hypertensive is much more dangerous than continuing to take for a few days a drug that is part of the recalled batch," according to Jean-Michel Race.
ANSM set up a toll-free number in July to answer questions from patients and their families (0800 97 14 03).
Source link
