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- Title
Metformin recalls: regulatory background, concerns and challenges.
- Authors
Sadasivam, Balakrishnan; Fatima, Zeenat; Atal, Shubham
- Abstract
In February 2020, the FDA released laboratory results for some metformin products approved in the USA stating that the levels of NDMA in the metformin products tested did not exceed the acceptable daily intake for NDMA. Conclusion Although such instances of drug recalls are not uncommon and faced by many drug manufacturers during routine and stress testing and even after marketing, these have been largely minimized with the implementation of regulations for the registration of pharmaceutical drugs. Global regulatory background Nitrosamine contamination with N-nitrosodimethylamine (NDMA), nitrosodiethylamine (NDEA), and N-nitroso-N-methyl-4-aminobutyric acid (NMBA) exceeding the US FDA acceptable limits was first detected in in angiotensin receptor blocker (ARB) drugs in 2018 with the FDA issuing voluntary recalls of three batches of valsartan manufactured by Zhejiang Huahai Pharmaceuticals, which was later expanded to irbesartan and losartan [[7]]. Metformin is the most widely prescribed orally active anti-hyperglycemic drug in the world today, which was discovered way back in the seventeenth century and launched in the twentieth century [[1]].
- Subjects
TYPE 2 diabetes; METFORMIN; ANGIOTENSIN-receptor blockers
- Publication
Wiener Klinische Wochenschrift, 2021, Vol 133, Issue 15/16, p851
- ISSN
0043-5325
- Publication type
Article
- DOI
10.1007/s00508-021-01822-1