FDA Asks Ranitidine and Nizatidine Makers to Expand NDMA Testing

By Amy Orciari Herman

Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS

The FDA is now asking manufacturers to test all lots of ranitidine (brand name, Zantac) and nizatidine (brand, Axid) for N-nitrosodimethylamine (NDMA) — a probable human carcinogen — before releasing them to the public.

If the NDMA level exceeds the acceptable daily intake limit (for ranitidine, 96 nanograms per day or 0.32 parts per million), the product should be held back, and the company should inform the FDA.

In its announcement, the agency notes 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." Accordingly, people who continue using these medications "should consider limiting their intake of nitrite-containing foods, e.g. processed meats and preservatives like sodium nitrite."