Contamination of drugs with nitrosamines: health risks and drug recalls in Brazil

Abstract

Nitrosamines are mutagenic compounds with high carcinogenic potential included in the cohort-of-concern list. In 2018, nitrosamine impurities were detected in active pharmaceutical ingredients and pharmaceuticals. Since then, controlling and monitoring nitrosamines in drugs has become a priority for regulatory agencies worldwide to protect the population’s health. This work aimed to survey drug recalls in Brazil from 2018 to March 2022 due to suspicion or confi rmation of the presence of nitrosamines. For this, online searches were carried out on the Brazilian Health Surveillance Agency website. The surveillance actions resulted in the suspension of imported active pharmaceutical ingredients and the recall of several batches of drugs
marketed in Brazil, such as valsartan, losartan, ranitidine, metformin, and varenicline. Drug recalls involved 20 companies and revealed many products, especially those containing ranitidine and metformin. Although nitrosamine impurities in drugs are found in low concentrations, products of continuous use and/or high doses deserve special attention to guarantee the treatment’s safety.