Series 1 - Nitrosamine Introduction

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1# What are nitrosamines?


First found 100 years ago, nitrosamines never received the spotlight in the pharmaceutical or chemistry world, as happened earlier in 2018. Back then, the world was shocked by the United States Food and Drug Administration's (US-FDA) discovery of one of the nitrosamine compounds, N-Nitrosodimethylamine (NDMA), contaminating the Valsartan drug beyond acceptable levels. Valsartan is one of the hypertension drugs that works by relaxing blood vessels to prevent heart failure and its complications. This discovery led to a massive voluntary recall of Valsartan drug across all drug manufacturer companies worldwide, which later caused a drug shortage phenomenon.
Figure 1. Valsartan Tablets
(Source: https://www.aboutlawsuits.com/valsartan/)

Maybe we all wonder why these actions are necessary. This NDMA compound was identified as a carcinogenic compound that may cause cancer, and its presence in vast amounts in life-saving drugs is undoubtedly a serious concern. According to Tuesuwan and Vongsutilers, more than 41 nitrosamine compounds have been identified. Not just Valsartan, these nitrosamines are also possibly found in 173 other drugs, according to Wichitnithad et al.

Why are there numerous drugs that might be affected by nitrosamines? 
This may be answered by how nitrosamines formed itself.


References:

  1. US-FDA, https://www.fda.gov/media/141720/download, (accessed May 2024).
  2. US-FDA, https://www.fda.gov/news-events/press-announcements/fda-announces-voluntary-recall-several-medicines-containing-valsartan-following-detection-impurity, (accessed May 2024).
  3. B. Tuesuwan and V. Vongsutilers, J Pharm Sci, 2023, 112, 1192–1209.
  4. W. Wichitnithad, S. Nantaphol, K. Noppakhunsomboon, W. Thitikornpong and P. Rojsitthisak, Talanta, 2023, 254, DOI: 10.1016/j.talanta.2022.124102.


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