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FDA: Carcinogen found in diabetes and heartburn drugs

This Oct. 14, 2015, file photo, shows the U.S. Food & Drug Administration campus in Silver Spring, Md. Photo: AP/Andrew Harnik, File
This Oct. 14, 2015, file photo, shows the U.S. Food & Drug Administration campus in Silver Spring, Md.

Updated: December 10, 2019 06:26 PM

The U.S. Food and Drug Administration is investigating possible carcinogens called N-Nitrosodimethylamine (NDMA) in some diabetes drugs. 

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According to a news release, the FDA announced the detection of an impurity known as NDMA in some diabetes drugs. NDMA has also been found in common heartburn medications like ranitidine, which is commonly known as Zantac and nizatidine. 

The FDA states that everyone is exposed to some level of NDMA because it is a common contaminant found in water and foods, including cured and grilled meats, dairy products, and vegetables. The FDA and the international scientific community do not expect it to cause harm when ingested at low levels. The acceptable daily intake limit for NDMA in the U.S. is 96 nanograms. 

Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, stated that while the agency is aware that some regulatory bodies outside the U.S. may be recalling some metformin diabetes drugs, there are no recalls affecting the U.S. market at this time. The FDA is investigating whether metformin drugs in the U.S. market contain NDMA, and whether it is above the acceptable daily intake limit of 96 nanograms. 

If someone is exposed above the acceptable levels of NDMA over a long period of time, it may increase the risk of cancer, according to the FDA. But a person taking a drug that contains NDMA at-or-below the acceptable daily intake limit every day for 70 years is not expected to have an increased risk of cancer. 

On Dec. 4, the FDA has announced it has asked the manufacturers of ranitidine and nizatidine products to expand their testing of NDMA. They want them to include all of the lots of the medication before making them available to consumers. 

According to a statement, the FDA will continue to work with others to figure out the issue of the NDMA.  

"We continue to work with industry and regulatory agencies around the world to determine the reasons for NDMA in these drugs and have developed and posted multiple testing methods to identify NDMA in ranitidine. Our scientists have determined ranitidine does not form NDMA in typical stomach conditions. However, we need further investigation to fully test how ranitidine and nizatidine behave in the human body and have plans to study this. There is also some evidence that there may be a link between the presence of nitrites and the formation of NDMA in the body if ranitidine or nizatidine is also present. Because of this, consumers who wish to continue taking these drugs should consider limiting their intake of nitrite-containing foods, e.g. processed meats and preservatives like sodium nitrite."

According to the FDA, their testing has not found NDMA in Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole), or Prilosec (omeprazole).

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Helen Do

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