The generic drug industry is urging the Food and Drug Administration (FDA) to “revisit and potentially reassess” its safety limits for common nitrosamines in pharmaceutical drugs and is proposing the agency instead adopt a “balanced risk-based approach” to evaluating drugs for the potential of nitrosamines using science-based considerations based on duration and type of use.

“The generics industry stands ready to work with the FDA so that we can strike the right balance, that of quality and safety,” the Association for Accessible Medicines said in a statement. “Further we stand ready to work with the FDA to mitigate creating or potentially exasperating unintended consequences, such as drug shortages, process improvements that are overburdensome and unsustainable for the FDA and industry, and we refine risk-based approaches to better manage the concerns nitrosamines present.”

On Sept. 1, the FDA announced that it had released new guidance to help drug companies detect and prevent nitrosamine impurities from getting into drugs. The announcement came after waves of drug recalls due to contamination with the nitrosamine NDMA, short for N-nitrosodimethylamine, a probable human carcinogen.

zantac label 375x210 Generic drug agency urges FDA to rethink its stance on NDMAThe environmental contaminant turned up two years ago in the blood pressure medicine valsartan and other so-called ARB drugs. Last year, NDMA was found in the heartburn drug Zantac and other medicines containing ranitidine. The FDA ultimately pulled all Zantac products from the market due to safety concerns. More recently, NDMA has turned up in several extended-release versions of the first-line diabetes drug metformin, as well as some tuberculosis treatments.

“There are many reasons why these impurities might appear in some drugs, and consequently many approaches to screening for and preventing the appearance of nitrosamines to help ensure drug quality and safety. 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 in its statement about the new guidance. “Under FDA’s oversight, manufacturers are responsible for mitigating these impurities.”

No studies have been published that identify a person’s risk of developing NDMA from medication they consumed, or what specific cancers for which they may be at risk. Some cancers that may be related to NDMA include stomach, small intestine, bladder, kidney, colorectal, esophageal, prostate, pancreatic, leukemia, non-Hodgkin’s lymphoma, and multiple myeloma.

Zantac lawsuits

Attorneys with Beasley Allen Law Firm are currently investigating claims of those who have used Zantac, which was voluntarily recalled from the market on Sept. 13, 2019, and withdrawn on April 1, and has been linked to certain types of cancer, including liver, bladder, stomach, colon, kidney and pancreatic cancer. If you or a loved one was a regular user of Zantac or any other product containing ranitidine and have been diagnosed with cancer, we would like to talk with you. Contact Frank Woodson, one of our leading pharmaceutical attorneys in charge of Zantac cancer claims.

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