As FDA continues ranitidine testing, says alternatives are safe

In the ongoing investigation into the detection of N-nitrosodimethylamine (NDMA) in ranitidine (Zantac) medications, FDA said it has "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, that the drugs must be tested in the human body to fully determine if ranitidine forms NDMA.

In the meantime, FDA continues to stand by its recommendation that consumers consider using OTC alternatives such as famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid), and omeprazole (Prilosec). FDA’s tests of samples of these alternative products show no NDMA impurities.

In addition, FDA said 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.”

So far, FDA and industry testing of medicines in the histamine-2 blocker and PPI classes has identified NDMA only in ranitidine and nizatidine.

Woodcock 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 being asked to continue conducting their own lab tests for NDMA levels in ranitidine and nizatidine and to send samples to FDA for testing.