Final Guidance on Nitrosamine Impurities in U.S. Drugs
On September 3, 2020, the U.S. Food and Drug Administration (FDA) announced that they were making available final guidance on nitrosamine impurities in medications manufactured for human consumption. The 26-page guidance document recommends steps that manufacturers of drug products and pharmaceutical ingredients should take in order to detect and prevent unacceptable levels of nitrosamine impurities in their products. The guidance document also describes how nitrosamine impurities may be introduced during the manufacturing process. The guidance was spurred by the recent findings of nitrosamine impurities in drugs such as ranitidine, angiotensin II receptor blockers, metformin, and nizatidine. Nitrosamine impurities are recognized as likely human carcinogens. The discovery of these impurities in drug products has crystallized the need for a strategy of risk assessment to identify and minimize the dangerous chemicals in pharmaceutical products.
Timely Manufacturer Action is Necessary
The guidance document for the pharmaceutical industry is entitled “Control of Nitrosamine Impurities in Human Drugs.” The guide was issued early this month without prior public comment because of the importance of providing manufacturers with timely information about testing, risk assessments, and actions they should take in order to mitigate the impurities in drug products.
The guidance also seeks to inform drug manufacturers of the causes of NDMA formation. It recommends methods of risk assessments that drug manufacturers can conduct on their products. The guidance then gives suggestions for actions to prevent or reduce the presence of nitrosamines in their products. It was urged that the risk assessments be done in a timely manner. It was also advised that all risk assessment documents be retained by the manufacturer so they can be produced if subsequently requested.
FDA Recall Related to NDMA
The World Health Organization (WHO) has classified nitrosamines as probable human carcinogens. The FDA and other regulators have conducted a detailed study of the impurities found in active pharmaceutical ingredients and drug products. Recent stability testing done by the FDA revealed that levels of N-Nitrosodimethylamine (NDMA) in some ranitidine products that were stored at room temperature could increase to unacceptable levels with time. This is a departure from other studies that found that the levels of NDMA increased at higher temperatures. Other FDA tests suggested that NDMA levels could increase with storage time. Because of these findings, the FDA recalled all ranitidine products from the American market on April 1, 2020.
Recommendations for Approved or Already Marketed Drug Products
The guidance document concludes by saying that in order to ensure the safety of the United States drug supply, drugmakers should finish a risk assessment of approved or marketed products within six months of the date of the guidance publication (by March 3, 2021). Confirmatory testing should begin immediately for high-risk products, and as soon as any risk of nitrosamine is identified from a risk assessment. The guidance says confirmatory testing of pharmaceutical products should be done within three years of the guidance date (by September 3, 2023).
Watch the YouTube of a news report about NDMA entering the U.S. drug supply.
Sacramento Drug Products Liability Attorney
Hello, and thank you for reading. I’m Ed Smith, a drug products liability lawyer in Sacramento, California. Defective and dangerous drugs can cause cancer, injuries, and even death. If you have suffered harm to your health as a result of using a mislabeled or defective medication, reach out to my office for compassionate, free, and friendly advice. Our local number is (916) 921-6400, and from out of the area, call toll-free at (800) 404-5400. My website, AutoAccident.com, also offers an option to contact us online.
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