MORE batches of the high blood pressure drug Valsartan have been taken off the shelves after tests revealed the presence of N-Nitrosodimethylamine (NDMA), a substance which could be cancerous, in some samples.
Changes in the manufacturing process at the Zhejiang Huahai Pharmaceutical laboratory in China – authorised by the European Directorate of Quality in Medications (EDQM), part of the Council of Europe – involved a fresh battery of tests on drugs containing Valstartan as its principal ingredient or in combination with others.
The traces of NDMA have led to numerous countries being placed on immediate alert.
As a result, the Spanish Medications and Healthcare Products Agency (AEMPS) had already withdrawn several batches in July, but has now announced another list of the drugs are to be taken off sale.
Pharmacies have been warned and anyone taking medication for high blood pressure should check the ingredients carefully on their pill boxes, and return to their GP for a new prescription straight away.
Patients should not stop taking their pills in the meantime, since the risk to health of hypertension being unmedicated is greater than that present in Valsartan if taken for a few more days.
Boxes can be taken to the pharmacy to check whether they are part of the withdrawn batches and can be replaced without cost to the patient.
Those retailed by 17 pharmaceutical laboratories are affected: Almus, Aurovitas, Kern Pharma, Alter, Combix, Cinfa, Normon, Ranbaxy, Stada, Pensa, Qualigen, Ratiopharm, Sandoz, Stada Generics, Tarbis, Tecnimede and Tedec-Meiji.
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