FDA Recalls More Antacids After Carcinogen Detected

fda recall antacidFDA Recalls More Antacids After Carcinogen Detected

The Food and Drug Administration (FDA) announced more recalls for Antacids after a cancer-causing carcinogen was detected. Zantac and other generic heartburn medications have been found to contain trace amounts of N-Nitrosodimethylamine (NDMA). The World Health Organization classifies NDMA as a “probable human carcinogen.” It is an environmental contaminant that can occur in drinking water. Exposure to high amounts of NDMA may cause gastric or colorectal cancer, according to the World Health Organization. It is extremely toxic to the liver. Even small amounts are linked to liver damage.

Ranitidine and Nizatidine Recall

Ranitidine is the generic version of the popular heartburn drug Zantac. It is an H2 (histamine-2) blocker that decreases the acidity in the stomach and frequently used for heartburn. Several batches of unexpired ranitidine tablets were initially recalled by Denton Pharma Inc, according to the FDA. This was followed by two more pharmaceutical companies – Appco Pharma and Northwind Pharmaceuticals – voluntarily recalling generic ranitidine tablets. CVS and Walgreens issued a statement that they have suspended the sale of Zantac and other ranitidine medications until further notice.

Nizatidine is another antacid found to contain trace amounts of NDMA. It is used for short-term treatment of stomach ulcers as well as heartburn caused by gastroesophageal reflux disease (GERD).

FDA guidelines

While NDMA levels were (at times) above acceptable limits, the amount found in the drugs is similar to levels you would be exposed to if you ate “grilled or smoked meats.” The FDA continues to investigate the potential health risks associated with the amount of NDMA identified in the drugs. It advises companies to recall antacid drugs if they find NDMA levels exceeding 96 nanograms per day or 0.32 parts per million. The full list of recalled medications can be found here. More information will be posted to that page as the FDA learns more.

As of now, the FDA recommends patients taking prescription ranitidine who wish to stop should talk to their health care professional about other treatment options. Multiple drugs are approved for the same or similar uses as ranitidine. Heartburn medications, such as famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) and omeprazole (Prilosec) have not tested positive for signs of NDMA, according to federal regulators.

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