US FDA announces more recalls of antacids containing traces of carcinogen

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To remove confusion, every drug label must mention that this drug is NDMA-free

In the last few years, N-Nitrosodimethylamine (NDMA) has made more news. More and more drugs are being withdrawn due to the presence of this carcinogen. The pharma companies should voluntarily mention on the label that their said molecule is NDMA-free.

The US Food and Drug Administration has recalled several more lots of heartburn medication, ranitidine, that have been found to contain trace amounts of a substance that may be linked to cancer. The WHO has classified the substance, NDMA, as a “probable human carcinogen.” None of the recalled lots has been associated with any injuries or adverse events.

Its unclear whether such trace amounts of carcinogens would cause harm when taken as directed. FDA testing of recalled ranitidine detected NDMA levels similar to the levels found in grilled and smoked meats. Federal regulators said other heartburn medications, such as famotidine, cimetidine, esomeprazole, lansoprazole, and omeprazole have not tested positive for signs of NDMA.

Dr KK Aggarwal

President CMAAO, HCFI and Past National President IMA