The U.S. Food and Drug Administration has released a guidance document for drug manufacturers outlining steps they can take to ensure their products are free of nitrosamines, an impurity that may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time, the agency said in a press release.
The guidance, Control of Nitrosamine Impurities in Human Drugs, recommends medication manufacturers develop a comprehensive risk assessment strategy and includes other actions that manufacturers can take to reduce or prevent the presence of nitrosamine impurities in their drugs.
“The source of these impurities can be related to the drug’s manufacturing process, the materials used in manufacturing, the drugs’ chemical structure, or even the conditions in which drugs are stored or packaged,” the FDA said.
The most common nitrosamine impurity, N-nitrosodimethylamine (NDMA), is found at low levels in water and foods, including cured and grilled meats, dairy products and vegetables. The FDA and the international scientific community do not expect NDMA to cause harm when ingested at low levels. However, given the risk that genotoxic substances such as NDMA may increase the risk of cancer if people are exposed to them above certain levels and over long periods of time, manufacturers have recalled drugs with NDMA levels higher than the FDA’s recommended acceptable intake levels.
