US FDA announces more recalls of antacids containing traces of carcinogen

USFDA announces more recalls of antacids containing traces of carcinogen

To remove confusion the drug label must have NDMA free

Dr KK Aggarwal

President CMAAO< HCFI and Past National President IMA

In the last few years NDMA has, made more news. More and more drugs are being withdrawn due to presence of this carcinogen.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 medications, Ranitidine that have been found to contain trace amounts of a substance that may be linked to cancer. The WHO has classified that substance, N-Nitrosodimethylamine (NDMA), as a "probable human carcinogen. None of the recalled lots has been associated with any injuries or adverse events.

It's unclear whether such trace amounts of the 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.

Ask Dr KK : How to combine clopidogrel with omeprazole?

There is a strong negative clopidogrel/esomeprazole interaction, compensated by increasing the dose of clopidogrel to 150mg or replacing esomeprazole with ranitidine. That is a simple solution to the PPI-induced clopidogrel resistance. [Moceri P, Doyen D, Cerboni P, Ferrari E; Thrombosis Research (Jul 2011)]

 Dr K K Aggarwal is Padmashri and Dr B C Roy National Awardee, President Heart Care Foundation of India, Dean Board of Medical Education Moolchand Medcity, Sr. Physician & Cardiologist, Visiting professor Clinical Research DIPSAR, Past President Delhi Medical Association, Past Academic and Research Wing Head IMA, Chairman Ethics Committee Delhi Medical Council.