Infarmed pulled various batches of medicines containing the active substance valsartan, which is used to treat high blood pressure, after impurities were found in it.
According to the national drugs authority, the impurity (N-Nitrosodimethylamine [NDMA]) identified under the European System of Suspension of Medicines was only detected in drugs whose active substance valsartan was manufactured by Chinese company Zhejiang Huahai Pharmaceuticals.
N-Nitrosodimethylamine, according to Diário de Notícias (DN), is “an organic chemical that can be toxic to the liver and other organs”.
“The Member States of the European Union, in conjunction with the European Medicines Agency (EMA), have, as a precautionary measure, recalled batches throughout the distribution circuit for potentially affected medicines”, Infarmed explains.
Infarmed recommends that patients who are using the affected medications, identified by DN as Decorsan Odis and Valsartan + Hidroclorotiazida Sandoz, do not discontinue their treatment, and should contact their doctor or pharmacist for prescription or dispensing of a replacement drug.
The National Drug Authority further clarifies that there are medicines with the same active substance, or valsartan associated with another substance, that will not be withdrawn because they are not included in the list drawn up by the authorities and therefore will remain on the market.
There are other medicines and alternatives available on the market with the same therapeutic indications, it stressed.