Batches of drugs based on valsartan containing a potentially carcinogenic molecule have been recalled since July 6. What approach should the patients concerned follow? Should they continue or stop their treatment?
Who says new health crisis, also says new questions of prevention. The National Medicines Safety Agency (ANSM) organized the recall of batches of generic drugs based on valsartan on July 6, a treatment used to stabilize blood pressure, to prevent the onset or recurrence of stroke or myocardial infarction. Available in generics since 2012, some batches could indeed contain traces of N-nitrosodimethylamine (NDMA), a potentially carcinogenic substance.
Arterial hypertension (HTA) affects 15 million people in France, or nearly one in three adults. According to study Esteban recently published by Public Health France, 36% of adult men are hypertensive today, against 25% of women. 60% of people over 65 suffer from this pathology; figures which climb to 80% among the over 80s. There are therefore many people affected by this health crisis.
What if you are concerned?
Many wonder: should they stop their treatment? The answer is no, especially not. “Patients treated with one of the affected valsartan specialties must neither stop their treatment on their own, nor return their boxes to the pharmacy”, underlines the ANSM, indicating moreover “that there is no acute risk for the patient linked to this quality defect. On the other hand, the risk of abrupt stopping of treatment is real (hypertensive surges, cardiac decompensations, neurological accidents). Also, patients should not in any case stop themselves. – even their treatment “. If in doubt, it is best to contact your pharmacist or your doctor.
Lack of quality of certain medicinal products #valsartan : what approach should be followed for the patients concerned? Consult the information document for patients. A toll-free number is also at your disposal.
?? More information on : https://t.co/Qxd6VRLZMp pic.twitter.com/A9tLgiLTbP– ANSM (@ansm) July 24, 2018
You can consult the list of batches affected by this manufacturing defect in click here. During the next delivery, pharmacists will also offer you one of the valsartan-based specialties not concerned. A toll-free number (0800 97 14 03) is accessible free of charge from Monday to Friday from 9 a.m. to 7 p.m.
A manufacturing defect that could date from 2012
On his site, the agency lists nine laboratories involved. These companies are ARROW GENERIQUES, BIOGARAN, CRISTERS, EG LABO *, EVOLUPHARM, RANBAXY PHARMACIE GENERIQUES, SANDOZ, ZENTIVA and ZYDUS. All of them subcontracted, in part or in whole, the production of the molecule to Zhejiang Huahai Pharmaceuticals, a Chinese manufacturer. In order to reduce production costs, generic drugs are indeed usually designed in China or India.
In one communicated published on July 17, the European regulator estimates that the manufacturing defect could date back to 2012, when the Chinese manufacturer changed its manufacturing process. An investigation has been opened by the European Medicines Agency (EMA) to determine the origin of the problem.
This recall of batches was organized with town pharmacies, wholesalers-distributors as well as hospital pharmacies and carried out in consultation with the Member States of the European Union. The United States has also organized a batch recall.
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