NDMA in Ranitidine Similar to Levels in Grilled Meats, FDA Says

By Amy Orciari Herman

Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH

Levels of N-nitrosodimethylamine (NDMA) in many tested ranitidine products are similar to those consumed through "common foods like grilled or smoked meats," the FDA said on Friday. Beginning in September, numerous ranitidine products have been recalled owing to high levels of NDMA, a probable human carcinogen.

The acceptable daily intake limit for NDMA in ranitidine has been set at 0.096 micrograms or 0.32 ppm. The FDA is asking manufacturers to recall all products that exceed these levels. It's also asking manufacturers to recall any nizatidine that has unacceptably high NDMA (nizatidine is chemically similar to ranitidine).

Additionally, the FDA conducted simulation tests to see what happens to ranitidine when exposed to gastric and intestinal fluids. The agency found that no additional NDMA forms in these environments, although tests in the human body are warranted.

The FDA says its recommendations for patients remain unchanged:

• Those using OTC ranitidine or nizatidine "can consider" using OTC alternatives, like famotidine or omeprazole.

• Those using prescription ranitidine or nizatidine should talk with their clinicians about other options.