what to do if you are under treatment?

Who says new health crisis, also says new prevention issues. The National Agency for Drug Safety (ANSM) organized the recall of batches of generic drugs based on valsartan July 6, a treatment used to stabilize blood pressure, to prevent the occurrence or recurrence of stroke or stroke. myocardial infarction. Generic since 2012, some batches may indeed contain traces of N-nitrosodimethylamine (NDMA), a potentially carcinogenic substance.

Hypertension (hypertension) affects 15 million people in France, nearly one million one in three adults. According to the Esteban study recently published by Public Health France, 36% of adult men are now hypertensive, against 25% of women. 60% of people over the age of 65 also suffer from this pathology; figures that climb to 80% among the over 80s. The people affected by this health crisis are so many.

What to do if you are concerned?

Many wonder: should they interrupt their treatment? The answer is no especially not. "Patients treated with one of the impacted valsartan specialties should not stop their treatment themselves, nor bring back their boxes to the pharmacy," says the ANSM, adding that "it does not exist. the risk of abrupt cessation of treatment is real (hypertensive attacks, cardiac decompensations, neurological accidents), and patients should not stop them. themselves their treatment ". If in doubt, it is best to contact your pharmacist or doctor.

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 on: https://t.co/Qxd6VRLZMp pic.twitter.com/A9tLgiLTbP

– ANSM (@ansm) July 24, 2018

You can view the list of lots affected by this manufacturing defect by clicking here. At the next delivery, pharmacists will also offer you one of the valsartan specialties not concerned. A toll free number (0800 97 14 03) is available from Monday to Friday from 9am to 7pm.

A manufacturing defect that could date from 2012

On its website, the agency lists nine laboratories involved. These are ARROW GENERIC, BIOGARAN, CRISTERS, EG LABO *, EVOLUPHARM, RANBAXY PHARMACIE GENERIQUES, SANDOZ, ZENTIVA and ZYDUS companies. All subcontracted, in part or totally, the production of the molecule to Zhejiang Huahai Pharmaceuticals, a Chinese manufacturer. In order to reduce production costs, generic drugs are usually designed in China or India.

In a statement issued on July 17, the European regulator estimates that the manufacturing defect could go back to 2012, when the Chinese manufacturer changed its manufacturing process. An inquiry was launched by the European Medicines Agency (EMA) to determine the origin of the problem.

This batch recall was organized at city pharmacies, wholesaler-distributors and hospital pharmacies. in consultation with the Member States of the European Union. The United States also organized a batch recall.

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