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Food and Drug Administration expands NDMA testing requirements

As the ranitidine recall situation continues to unfold across the country and here in Ohio, manufacturers, distributors and sellers are scrambling to get products off the shelves. In the meantime, the scientific community is attempting to figure out just how N-nitrosodimethylamine, popularly known as NDMA, ended up in this medication. As part of that initiative, the Food and Drug Administration has expanded its testing requirements of products containing ranitidine and now nizatidine as well. 

Manufacturers of products containing these two medications are required to test every lot produced before releasing them into the market, not just random samplings. Any lots that contain unacceptable levels of NDMA may not leave the manufacturing facility, and the company must notify the FDA. The "acceptable" limit of this human carcinogen in ranitidine medications made available to consumers is 0.32 parts per million or 96 nanograms.

Part of the inquiry revolves around how the medication acts in the human body since there appears to be a link between the presence of nitrites and the formation of NDMA in the digestive process. The FDA says that this process seems to occur with certain foods, not just ranitidine. The agency also continues to stress that other acid reducing medications are available that should serve as a suitable substitute for those who used to take the drugs in question.

While the Food and Drug Administration continues its search for answers, so do consumers who wonder whether they will end up with cancer because they trusted these medications were safe. The repercussions of this issue are just beginning, and it could take years for the true extent of the danger becomes clear. In the meantime, Ohio residents who believe their cancer may be connected to Zantac or some other medication containing ranitidine or nizatidine would probably benefit from discussing the matter with an attorney to determine whether litigation would be appropriate.

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