precautionary recall of certain drugs based on valsartan

Certain valsartan-based drugs used for heart failure, arterial hypertension, and after recent cardiac infarction are recalled as a precautionary measure because of the presence of impurity found at the Chinese manufacturer, said Friday the Drug Agency.

"There is no risk of acute toxicity to the patient.Patients should not stop their treatment," said Dr. Dominique Martin, head of the ANSM Medication Agency. About 1.3 million patients are concerned, nearly half of the patients treated in France with this molecule. Nine laboratories are concerned

All generic concerned This measure of withdrawal of products in pharmacies "concerns about half of valsartan specialties, all generic," adds Dominique Martin. The defect has been reported by the European Medicines Agency (EMA). With her, the Member States of the European Union decided collectively and in a concerted manner this recall of lots of drugs affected by this "defect" throughout the European territory.

An impurity found in the substance active. The quality defect detected is an impurity found in the active substance manufactured by the Chinese company Zhejiang Huahai Pharmaceuticals. This impurity is N-nitrosodimethylamine (NDMA), a substance clbadified as probably carcinogenic in humans. The productions of the active substance of this company were stopped and the drugs which contain it and which are marketed in France were quarantined by the laboratories at the end of June 2018.

The list of the lots is available on line . In France, Arrow Génériques laboratories, Biogaran, Cristers, EG Labo, Evolupharm, Ranbaxy Pharmacy Generics, Sandoz, Zentiva and Zydus, in agreement with the ANSM, are recalling all unexpired lots of products including drug broadcasts the list online. For Eg Labo, only the lots mentioned are concerned. The other valsartan or other drugs of the same therapeutic clbad (other sartans) are not concerned to this day and remain available, notes the ANSM.

An investigation in progress. Patients treated with one of the valsartan medicines on the list should not stop treatment themselves or take their boxes to the pharmacy. During a next issue, the pharmacist will propose a drug based on valsartan not concerned by this defect, says the health agency. For any questions, patients may contact their doctor or pharmacist. An investigation into this quality defect is under way at European level.