The Ministry of Health has ordered the withdrawal of more than a hundred of medicines that contain the active ingredient “valsartan”, prescribed to control hypertension, but warns users not to leave your treatment without your doctor’s substitute on the other.
According to have informed to Efe sources of Health, “is very important” that those affected do not interrupt your treatment suddenly without informing your doctor.
The recall and alert of these drugs has been carried out by “prevention” after detecting “N-Nitrosodimetilamina (NDMA)”, an impurity that could cause cancer, according to the International Agency for Research on Cancer (IARC) of the World Health Organization (WHO).
The drugs affected, all of them in the form of tablets, have been distributed by the pharmaceutical laboratories and Kern Pharma, Alter, Cinfa, Normon, Pensa Pharma, Sandoz, Almus, Aurovitas Spain, Combix, Ranbaxy, Stada, Qualigen, Ratiopharm, Tarbis, Tecnimede España, Tedec-Meiji Farma.
And affect the batches manufactured in China, explains on its website the Spanish drugs Agency (AEMPS).
The alert, which is due to a defect of quality, has taken place in multiple european countries and the rest of the world.
In the case of Spain, affects several presentations of medicines manufactured by Zhejing Huahai Pharmaceutical Co. including valsartan.
The Spanish Agency of medicines informs that, after receiving the relevant research, we have proceeded to order the recall of the products concerned.
The impurity “probably carcinogenic” has been generated as a result of a change in the manufacturing process of valsartan authorized by the EDQM (acronym in English of the European Directorate for the Quality of Medicines & HealthCare), the European directorate for the Quality of Medicines, Council of Europe.
Valsartan is an active ingredient that is used to treat high blood pressure and is available alone or in combination with other active principles.
And while the european authorities of medicines work with Zhejiang Huahai to resolve this situation as quickly as possible” and to evaluate their risks, have decided to order the withdrawal of medicinal products containing valsartan, explains the AEMPS.
In this situation, the health authorities recommend that patients who do not interrupt the treatment of stroke and who go to their doctor to be replaced by another with the same composition.
Physicians advised to look for the treatments in progress and change those that present the above-mentioned problem. And pharmacists urged to, with a prescription one of the drugs affected, inform the patient of the situation and indicate that you do not stop your treatment and contact your doctor.