Global Scare Over Nitrosamine Impurities Extends To Diabetes Medication
Singapore recalls trigger international reaction as metformin is added to growing list of chronic medications found to contain NDMA.
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FDA made request after finding unacceptable levels of nitrosamine NDMA can form during storage above room temperature or beyond expiry. Forthcoming guidance on detecting impurities like nitrosamines in any drug will call for routine testing as well as a chemical risk assessment “to look at what is the probability of generating them.
Agency worried what might happen beyond expiry or room temperature to generate carcinogenic impurities in ranitidine; will guide assessment of nitrosamine risks in other drugs.
An online pharmacy that tests medications before dispensing them advocated for regulations requiring independent testing and verification of the chemical content of pharmaceuticals; it also alleged that the US FDA’s testing method for evaluating the carcinogenic risk of metformin needs refinement.