FDA Explains Levels of Impurity Found in Recalled Heartburn Drugs

Regulatory NewsRegulatory News | 01 November 2019 |  By 

Following a series of recalls for the heartburn drug Zantac and other ranitidine drugs due to a genotoxic impurity, the US Food and Drug Administration (FDA) said Friday that the levels of the impurity in ranitidine drugs for heartburn and also in the chemically similar ulcer drug nizatidine “are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.”

The agency also published a table of the ranitidine and nizatidine samples tested, showing how some of the products would and would not be considered reasonably safe for human ingestion based on lifetime exposure.

The impurity, N-Nitrosodimethylamine (NDMA), was present in all samples tested, FDA said. 

“Although many of these levels of NDMA observed through FDA testing are much lower than the levels some third-party scientists first claimed, some levels still exceed what the FDA considers acceptable for these medicines,” said Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research.

For instance, ranitidine products from Sandoz, Aurobindo and Dr Reddy's exceeded the acceptable daily intake limit for NDMA, while ranitidine products from Strides Shasun and Watson did not, according to FDA’s analysis. The agency’s tests of samples of other drugs, such as Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole) and Prilosec (omeprazole) show no NDMA impurities.

FDA is now calling on the companies to voluntarily withdraw ranitidine and nizatidine products that do not meet the agency's NDMA threshold (96 nanograms per day or 0.32 ppm).

Laboratory Tests | Ranitidine


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