An independent laboratory near San Francisco has discovered that levels of the Zantac carcinogen NDMA may rise over time during storage and in high temperatures.

According to tests results from Alameda-based Emery Pharma, the amount of NDMA can rise to unacceptably high levels in as little as five days. Emery CEO Ron Najafi told Bloomberg News these recent findings indicate that Zantac carcinogen levels may increase on their own by simply allowing the medication to sit in medicine cabinets at room temperature.

Now, Emery is calling on the Food and Drug Administration to issue a complete recall of all stocks of the commonly-prescribed antacid medication. Currently, the FDA is conducting its own investigation in attempts to determine whether or not ranitidine can turn into NDMA after a patient has ingested the medication.

About Zantac

Zantac (raniditine) is primarily indicated for the treatment of acid reflux. It is also prescribed for patients suffering from peptic ulcer and Zollinger-Ellison Syndrome, a condition in which tumors cause excess production of stomach acid. It is essentially an antihistamine, decreasing acid production by temporarily blocking the action of histamine receptors found in cells lining the stomach.

The Zantac Carcinogen: NDMA

NDMA is an abbreviation for n-nitrosodimethylamine, also known as dimethylnitrosamine. This chemical compound is part of a class known as nitrosamines; trace amounts are found in many everyday products, including cured or smoked meats, cosmetics and other household goods, although most exposure comes from tobacco products. According to a report from the Centers for Disease Control, NDMA can be formed accidentally as the result of various industrial processes as well as chemical reactions involving alkylamines.

This is what may have happened in a factory in China, where the active ingredient for the hypertension drug valsartan was manufactured. Around 2012, a number of modifications were made to the manufacturing process that scientists believe may have resulted in the formation of NDMA.

Potential Health Dangers of NDMA

NDMA is a hepatotoxin, meaning that it primarily affects the liver. Short-term (acute) exposure can result in liver damage, causing symptoms that include:

• nausea
• vomiting
• headaches
• general, undefined discomfort and/or fatigue

Based on data from animal studies, scientists believe that long-term exposure to NDMA can increase the risk of tumors in the liver and other organs. Because of this, the Environmental Protection Agency has classified NDMA as a probable human carcinogen.

Discovery of the Zantac Carcinogen

NDMA was first detected in batches of Zantac at Valisure, a small, independent pharmacy in Connecticut that specializes in testing medications for safety and efficacy. After their results were verified by a second lab, they reported the results to the FDA.

Since September, the FDA has been doing its own monitoring of Zantac, reporting levels of NDMA that range from insignificant to potentially dangerous. The FDA has not issued a recall for the product, but several drugmakers and at least one hospital has removed ranitidine from pharmacy shelves pending further investigation.