SPAIN’S medications agency has withdrawn drugs prescribed for high blood pressure after finding they may contain a substance that could be carcinogenic.
At least 100 types of prescription medicine containing the active ingredient ‘Valsartan’ have been removed from circulation and the healthcare products agency, AEMPS, urges anyone who has been taking them to go straight to their GP and arrange to be given a substitute.
According to the World Health Organisation (WHO) and the International Agency for Research into Cancer (IARC) has detected a substance in Valsartan known as N-Nitrosodymethylamine (NDMA) in Valsartan which is not suitable for human consumption and can cause cancer.
Although the risk is not high, especially if – as is sometimes the case – Valsartan is combined with other active ingredients, the alert has been launched across Europe and worldwide and patients advised not to continue taking their pills.
Arterial hypertension drugs containing Valsartan are distributed by a number of well-known pharmaceutical laboratories including Cinfa, Normon, Pensa, Kern, Sandoz, Stada, Almus, Aurovitas, Combix, Ranbaxy, Qualigen, Ratiopharm, Tarbis, Tecnimede and Tedec-Meiji.
Those affected are from certain batches manufactured in China, and the European Medicines Agency (EMA) is now working closely with Zhejiang Huahai to resolve the situation.
This is said to have been caused by a change in the Valsartan manufacturing process authorised by the European Directorate for the Quality of Medicines and Healthcare (EDQM), part of the Council of Europe.
Spanish health authorities warn patients not to stop their treatment suddenly, but to get to their doctor as soon as they can for a new prescription.
High-street pharmacies have been instructed to give this same advice to customers who present them with a prescription for medications that include Valsartan.