Anvisa announced a new collection of losartan potassium for suspecting the presence of impurities and contamination during the manufacturing process. The measure was published on Wednesday, the 8th, in the Official Gazette, and involves the line produced by Vitamedic, in a dosage of 50 mg.
The drug is one of the leading prescriptions for treatments against hypertension and heart failure. In the whole of last year, sales moved R$ 721 million in the Brazilian market.
Losartan withdrawal is a precaution, says manufacturer
In a published statement, Vitamedic said the withdrawal of losartan represented a precautionary measure initiated by the drug’s own manufacturers, “as there are no data to suggest that the product containing the impurity caused a change in the frequency or nature of adverse events related to cancers, congenital anomalies or fertility disorders. Therefore, there is no immediate risk in relation to the use of this medication”.
“These impurities come from the manufacturing process of the active pharmaceutical ingredient and their presence was unknown until the publication of studies that indicated their possible formation during the synthesis of the substance losartan. The measures indicated in these cases have an impact on the entire losartan consumption market, not just restricted to Brazil”, he informed.
In February of this year, Sanofi Medley had already voluntarily suspended its production of losartan, as a precautionary measure due to the presence of mutagenic impurities in the drug batches.
Source: Panorama Farmacêutico Newsroom