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FDA Provides Guidance Regarding Impurities In Zantac, Other Drugs


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The FDA issued new guidance on Tuesday for the pharmaceutical industry on how to avoid drugs being contaminated with nitrosamines such as NDMA. Many drugs have been recalled due to NDMA contamination as of late, including medications containing ranitidine and valsartan.

The guidance called on the pharmaceutical industry to implement a series of recommended steps to avoid medications being contaminated by nitrosamines. The recommendations are not legally binding. Drug manufacturers could be exposed to liability if they don’t follow the recommendations, though.

“While nitrosamines are common in water and foods, nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time. For this reason, the discovery of unexpected nitrosamine impurities in some drug products is a serious concern,” the FDA said in a statement.

The EPA and the International Agency for Research on Cancer classify NDMA as a probable human carcinogen.

The guidance “suggests several general root causes of the presence of nitrosamine impurities” in medications, including acidic reaction conditions. It states that “in general, processes that use nitrites in the presence of secondary, tertiary, or quaternary amines are at risk of generating nitrosamine impurities.” It also notes that vendor-sourced materials can be contaminated, introducing nitrosamines to 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 guidance recommends a comprehensive risk assessment strategy as well as other steps drug makers can take to prevent or reduce nitrosamine impurities in their products.

The FDA said that patients taking drugs that might be contaminated by nitrosamines shouldn’t stop taking their medications and should consult with a healthcare professional.

“We believe that the guidance we’ve issued today will assist manufacturers in preventing unacceptable levels of nitrosamines in drugs,” the FDA said.

The FDA requested the removal of all products containing ranitidine from the United States market in April, due to contamination with NDMA. The FDA announced the recall of several valsartan-containing drugs due to contamination with NDMA in July 2018 and many other valsartan-containing drugs have been recalled since. Apotex Corp voluntarily recalled their metformin tablets due to contamination with NDMA in May and several other metformin-containing drugs have been recalled since.


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