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Zantac does not cause stomach upset, says the FDA



Laboratory test results showed that within the human digestive system, Zantac medicine does not form the impurity known as N-nitrosodimethylamine or NDMA, said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, in a statement on Friday.

Zantac is a type of ranitidine, a medicine for heartburn, stomach ulcers and other conditions that cause too much stomach acid.

"The information we have gathered as part of our ongoing investigation of ranitidine has been crucial in answering the questions we have been given about the potential risk of these products," Woodcock said.

"We also performed tests that simulate what happens to ranitidine after it has been exposed to acid in the stomach with a normal diet and the results of these tests indicate that NDMA is not formed through this process," she said. "Similarly, if ranitidine is exposed to a simulated small intestine environment, NDMA does not form. We still need to test the drugs in the human body to fully understand whether ranitidine forms NDMA."

NDMA has been classified as probable human carcinogen based on laboratory tests, and concern about Zantac containing levels of impurity appeared in September.

The FDA issued a statement in September that it had experienced that some ranitidine drugs, including Zantac, contain low levels of NDMA.

In the weeks following the statement, retailers Walmart, CVS Pharmacy and Walgreens Zantac and other ranitidine drugs undoubtedly withdrew from their shelves, and drug maker Sanofi voluntarily recalled the drug.
  after found contamination

Now it turns out that "although many of these levels of NDMA are observed through FDA testing is much lower than the levels that third-party researchers first claimed, exceeding some levels the FDA still considers acceptable for these drugs, "Woodcock said.

The "acceptable limits" for NDMA are 96 nanograms per day or 0.32 ppm. In Woodcock's statement, she said that if the FDA or manufacturers find NDMA levels above this limit, companies will be asked to voluntarily recall their ranitidine products.

"We would also ask manufacturers to voluntarily remember nizatidine, often known as Axid, if they found NDMA above the acceptable daily intake level because it chemically resembles ranitidine," Woodcock said, adding that manufacturers should continue to carry out their own laboratory tests.

"We are still working with manufacturers to investigate the true source of NDMA and to understand the root cause of the low levels of NDMA present in medicine," she said.

If you are taking non-disk ranitidine products or nizatidine, antacid medications, the FDA recommends considering other products that have not received disk for their conditions.

FDA tests of other medications, such as Pepcid, Tagamet, Nexium, Prevacid and Prilosec, have not shown any NDMA impurities in the drugs, according to Woodcock's statement. If you are taking prescription ranitidine or nizatidine, you should talk to your doctor about another treatment option.

"There are several drugs that are approved for the same or similar uses as ranitidine and nizatidine," Woodcock said.


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