96 nanograms
Is the maximum daily amount of NDMA advised for consumption by FDA
3,000,000 nanograms
of NDMA was found during previous testing of one Zantac pill.
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Based upon recent testing by a popular independent laboratory and a resulting petition filed with the FDA, there are claims that Zantac (ranitidine) causes high levels of Nitrosodimethylamine (NDMA) exposure in patients. Essentially, the claims are that, aside from this testing, recent studies have confirmed that the unstable molecules of the medication break down in the digestive tract to create harmful levels of NDMA (especially if the ranitidine comes into contact with nitrites in the digestive tract). Based upon these claims, significant NDMA exposure could result from taking brand name or generic ranitidine products, regardless of where they were manufactured.
NDMA is listed by the International Agency for Research on Cancer (IARC) as a compound that is probably carcinogenic to humans, and by the US National Toxicology Program (NTP) as a compound reasonably anticipated to be a human carcinogen. In fact, NDMA is actually used in the research laboratory setting to induce cancer in rats.
Similar types of NDMA exposure have been linked to various primary cancers, including:
And, in more limited circumstances:
Laboratory analysis of ranitidine & nizatidine products
For reference, consuming up to 0.096 micrograms or 0.32 parts per million (ppm) of NDMA per day is considered reasonably safe for human ingestion based on lifetime exposure. FDA has set the acceptable daily intake limit for NDMA at 0.096 micrograms or 0.32 ppm for ranitidine.