The agency said nitrosamines are common in water and foods but they may increase the risk of cancer if people are exposed to them above acceptable levels for long periods of time.
The FDA said Aug. 26 that it was aware of nitrosamine contamination in the antibiotics rifampin and rifapentine, but that it wouldn’t ask drugmakers to recall them because it wanted to avoid a shortage of the lifesaving drugs.
The most common nitrosamine, N-Nitrosodimethylamine, or NDMA, has prompted numerous recalls in the last year after it was discovered in ranitidine and metformin.
The FDA published the guidance, titled “Control of Nitrosamine Impurities in Human Drugs” Sept. 1 to be immediately implemented by drugmakers, who are responsible for reducing nitrosamine impurities, the agency said.
Nitrosamines can be formed in drugs via the manufacturing process, materials used in manufacturing, a drug’s chemical structure, or the conditions in which drugs are stored or packaged, the FDA said.
Read the FDA’s full news release here.
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