FDA statement on new testing results, including low levels of impurities in ranitidine drugs

In the ongoing investigation into the detection of N-Nitrosodimethylamine (NDMA) in ranitidine (Zantac) medications, an FDA official said Friday the agency "found levels of NDMA in ranitidine that are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats." According to Janet Woodcock, MD, direc

In the ongoing investigation into the detection of N-Nitrosodimethylamine (NDMA) in ranitidine (Zantac) medications, an FDA official said Friday the agency "found levels of NDMA in ranitidine that are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats." According to Janet Woodcock, MD, director of FDA's Center for Drug Evaluation and Research, results from tests that simulate what happens to ranitidine after it has been exposed to stomach acid with a normal diet indicate that NDMA is not formed in the process, nor is it formed if ranitidine is exposed to a simulated small intestine environment. She noted, however, the drugs must be tested in the human body to fully determine if ranitidine forms NDMA. She added, "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. ... We would also ask manufacturers to voluntarily recall nizatidine, commonly known as Axid, if they found NDMA above the acceptable daily intake level because it is chemically similar to ranitidine." Manufacturers are also asked to continue conducting their own lab tests for NDMA levels in ranitidine and nizatidine and to send samples to FDA for testing. The agency said that its recommendations for consumers have not changed. "Consumers taking OTC ranitidine or nizatidine can consider using other OTC products approved for their condition," FDA said. Additionally, individuals "taking prescription ranitidine or nizatidine should speak with their health care professional about other treatment options. There are multiple drugs approved for the same or similar uses as ranitidine and nizatidine," FDA noted.