FDA Recalls More Heartburn Medications Over Presence Of Cancer Causing Chemical NDMA

FDA Recalls More Heartburn Medications Over Presence Of Cancer Causing Chemical NDMA


Three more heartburn medications have been recalled after traces of cancer-causing chemical NDMA. Both Denton Pharma and Appco Pharma have voluntarily recalled their ranitidine products this week. Ranitidine tablets are generic forms of the popular heartburn medication Zantac. Both the companies have recalled several batches of ranitidine tablets of 150 mg and 300 mg tablets. These tablets were delivered to Crosswind Pharmacy and Northwind Pharmaceuticals LLC. According to the Food and Drug Administration, pharmaceutical company Mylan had issued a recall of nizatidine after finding some traces of the same carcinogen. There are no reports of any individual getting sick related to these recalls.

The US Environmental Protection Agency considers NDMA as an impurity that carries possible carcinogen. Certain chemical reactions can cause the unintentional introduction of NDMA into manufacturing. FDA started testing several drugs after the impurity was found in medicines of heart failure and blood pressure known as ARBs. The testing has been going on since 2018. In October last year, several major retailers decided to halt the sale of ranitidine medications over concerns of the presence of impurity. Earlier, pharmaceutical company Novartis announced that it would stop the distribution of all ranitidine drugs manufactured by Sandoz.

Several lawsuits have already been filed that asserted that drug Zantac caused cases of cancers. A Citizen Petition has been submitted to the FDA asking it to suspend sales and recall all ranitidine in the United States. The drug regulator said the level of NDMA found in ranitidine were those comparable to what one might get exposed to from eating grilled or smoked meat. Caleb Alexander, a pharmacy epidemiologist, said that more research needs to be conducted to find out more about antacid medications. Alexander said that getting cancer from taking heartburn medications are very low. However, countries liked Switzerland, Canada, and German have pulled ranitidine from stores. In the US, individual companies decided to pull their medications. The FDA has advised people to consult their doctors about switching drugs.

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