BRIEF—Expand testing of heartburn drugs, FDA tells manufacturers

Companies that manufacture ranitidine and nizatidine have been told to include all lots for N-nitrosodimethylamine (NDMA) before making them available to consumers.

The FDA has previously warned about the detection of NDMA in the common heartburn medications, which are available over the counter or by prescription, and had asked manufacturers to conduct tests prior to this instruction to expand testing.

Ranitidine is commonly known as Zantac while nizatidine has gone by brand names including Tazac and Axid.

If testing shows NDMA above the acceptable daily intake limit – 96 nanograms per day or 0.32 parts per million for ranitidine – the manufacturer must inform the agency and should not release the lot for consumer use.