Recall of lots of irbesartan medicines: a toll-free number for information

As part of the ongoing investigations into the presence of N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) impurities in medicinal products belonging to the sartan family of medicinal products, controls on batches of irbesartan-based medicinal products have revealed the presence of NDEA at levels exceeding the acceptable limits. The laboratory, in agreement with the ANSM, shall therefore recall the non-compliant batches.

ANSM states that

the potential presence of NDMA and NDEA does not pose an acute health risk to patients

. This is why patients must not stop their treatment without medical advice, any sudden stopping exposing them to the risk of hypertensive attacks, cardiac decompensation, neurological accidents... They should check with a pharmacist whether their drug is affected by the quality defect. If it is, they continue to take it and consult their doctor who will adjust the treatment in the case of valsartan, or ask their pharmacist for a pack not affected by the defect in the case of irbesartan. If the drug is not affected, they can continue their treatment.

Regularly updated lists of the medicinal products concerned and those which are not are available on the ANSM website.