Popular Heartburn Medication May Contain Carcinogens, Says FDA

The Food and Drug Administration recently announced an immediate recall of all over-the-counter heartburn drugs containing the active ingredient ranitidine. Popularly sold under the brand name Zantac, these medications are designed to treat chronic acid reflux and stomach ulcers.

In 2019, the FDA scrutinized Zantac and related pharmaceuticals for containing trace amounts of probable cancer-causing contaminants. However, at that time the FDA did not issue a recall and also did not recommend to the public that they should stop taking the medication despite a voluntary recall of ranitidine by some manufacturers.

The administration has seemingly reversed course—now recommending that consumers immediately stop taking Zantac and discard any remaining supply.

Why did the FDA recall it?

An agency spokesperson admitted that levels of a carcinogen known colloquially as NDMA could increase in the drug after it manufacture, depending on how it was stored or transported. High storage temperatures could naturally increase levels of the cancer-causing agent. Over time, prolonged use of drugs containing the contaminate may cause cancer in humans.

“Since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients,” explains FDA Division Director Dr. Janet Woodcock.

Woodcock also notes that a number of similar alternatives to Zantac remain on the market today, including brand name products like Nexium, Prilosec, and Tagament. These drugs are not known to contain the same cancer-causing chemical (NDMA) as Zantac.

While dozens of voluntary recalls have been initiated by Zantac and its manufacturers within the last year, this mandated removal of the product from store shelves is sure to raise questions about culpability on the part of the company and the FDA. Making matters worse is the indefinite suspension of all foreign and domestic FDA inspections due to travel restrictions put in place following the novel coronavirus outbreak.

It remains unclear when the agency may complete an investigation into the contamination of the popular heartburn medication Zantac. At this time, however, at least one manufacturing plant in India has been sanctioned.

Should consumers dispose of existing Zantac tablets?

The FDA advises consumers to stop taking Zantac immediately and throw any remaining liquids or tablets in the trash. As mentioned above, a number of name brand heartburn medications and generic antacids are still available for purchase. Lifestyle and dietary changes are also recommended for people experiencing chronic acid reflux and stomach ulcers.

Consumers who have used Zantac to treat heartburn and have received a subsequent cancer diagnosis may consider safely storing any remaining supply in its original packaging and sealing it in a plastic bag. An attorney may wish to retain opened Zantac containers for use as evidence in the event the consumer seeks legal representation.