New valsartan recalls, expected stockouts

New drug recalls based on valsartan were announced Thursday in France by the agency of the drug (ANSM) because of the presence of a substance clbadified as probably carcinogenic, which will lead to stock-outs after a first wave recalls early July.

In total, the combination of the two boosters affects three-quarters of these drugs used in heart failure, high blood pressure and after a recent cardiac infarction. Between 1.2 and 1.5 million patients in France follow this treatment.

Impurities in chinoix labs

The first international recall, involving nine brands, was motivated by the presence of an impurity, N-nitrosodimethylamine (NDMA), a substance clbadified as probably carcinogenic to humans. The Chinese company Zhejiang Huahai Pharmaceuticals was initially questioned, before two other Chinese laboratories, Rundu Pharma and Tianyu Pharm, were in turn 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, NDEA (N-nitrosodiethylamine)". 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.

Expected stock shortages

This second undesirable substance "has been highlighted following the many investigations undertaken since July at the European level concerning valsartan".

Manufacturers of drugs that are not concerned by the two recalls "are currently not able to increase their production sufficiently to cover all the needs of French patients," said the ANSM. As a result, "large stockouts are expected quickly".

"There are many therapeutic alternatives available to ensure optimal management of patients currently treated with valsartan," says the ANSM. She advises patients to 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 attacks, cardiac decompensations, neurological accidents), patients must not under any circumstances interrupt their treatment without medical advice", insists the ANSM, which set up in July a green information number (0800 97 14 03).