N-nitrosodimethylamine (NDMA) and some prescribed medicines: A mini-review

Abstract

Recently, there have been notices of drug recalls by different pharmaceutical companies. This is based on the finding of high level of N-nitrosodimethylamine (NDMA) in such medications. These medications are useful in the management of some diseases which affect a significant percentage of the population. It is therefore necessary to evaluate the chemical substance (NDMA), the sources, mechanisms, and the effects it can pose on the users of implicated medications. It is also important to consider the possible ways to avert the entry of NDMA into the medications. The substance, NDMA, has been found to be present as an impurity in high concentration in certain drugs, especially metformin slow release, valsartan and ranitidine. The approved healthy daily intake of NDMA by Food and Drug Administration (FDA) is about 96 ng. However, the concentrations of NDMA found in these drugs were exceptionally high which led to their recall. The high level of NDMA may arise from contamination, direct synthetic process, or from the degradation process of the medicine. Chromatography is the best detection modality of NDMA. The carcinogenic risk is the most feared effect of accumulated NDMA beyond the acceptable limit. On the basis of the frequent recalls of these medications, it is therefore imperative that pharmacists, pharmacologists, and physicians are acquainted with the sources of NDMA. This is in view of the serious risk it can pose to patients’ safety and quality of life. These concerns have given rise to this review article.