Valsartan contaminated: what if I am concerned?

What to do when one of the 1,300,000 people on the drug Valsartan, some of whom have recently been recalled for contamination? First, do not stop the medication on its own, then follow the recommendations of the Medicines Agency (ANSM) below.

Contamination and batch recall

Valsartan is used in taking burden of heart failure, in arterial hypertension and post-myocardial infarction. Some of the medicinal products containing them have been withdrawn by ANSM at the beginning of July 2018. They had been informed by the European Medicines Agency (EMA) of contamination of the active substance by an impurity " unpredictable, potentially related to the change in the manufacturing process of valsartan "by the Chinese company Zhejiang Huahai Pharmaceuticals.

This substance, called N-nitrosodimethylamine (NDMA), is clbadified as a probable carcinogen by World Health Organization (WHO), but " can also be found in the environment (food, as well as, to a lesser extent, in water and air) ". According to the ANSM, it does however pose " no acute risk " for the patient, tempers the ANSM in a statement. " Toxicology experts from the European Medicines Agency (EMA) are currently evaluating the health impact of NDMA ," says the Medicines Agency. Consequently, " the Member States of the European Union decided collectively and in a concerted manner a reminder of the lots of specialties affected by this defect on the whole European territory ". " In France, the batches concerned by this quality defect have not been marketed since the end of June 2018 ", while " the other drugs based on valsartan, not affected by this defect, remain available ", explains the ANSM

What to do if I am concerned?

• First, check that your box is one of those that have been contaminated: list of medications concerned / list of drugs NO Concerned
• If your medication is concerned, do not stop taking it, because sudden discontinuation can lead to hypertensive attacks, cardiac decompensation, and potentially serious neurological accidents.
• If in doubt or to change for one uncontaminated equivalent medication, get closer to your doctor or pharmacist.
• To guide patients step by step, the ANSM sets up a free toll-free number from Monday to Friday at 9am at 7 pm on 0 800 97 14 03 .