FDA Pulls Heartburn Medication Zantac Off of the Market

By Gilreath & Associates

Ranitidine, better known by its brand name Zantac, is an over-the-counter and prescription drug used to treat heartburn. Recently, the U.S. Food and Drug Association (FDA) sent out a recall to manufacturers of this medication after running new tests and finding startling results.

The FDA’s ongoing investigation has revealed a contaminant in ranitidine known as N-nitrosodimethylamine (NDMA for short), which is considered a probable human carcinogen. This means it can cause cancer in human tissue.

When Zantac is stored for increased periods of time and at higher-than-normal temperatures (the average recommended temperature being between 68°F and 77°F), it can cause NDMA levels in the drug to increase as well. 

To date, other products used to treat the same problem as Zantac have not come back with the same results, according to the FDA.

Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, stated in a recent announcement that “the FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern.”

The FDA also urges patients who currently take Zantac over-the-counter or as a prescription to stop and take a different approved drug to treat their heartburn.

“There are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA,” according to the FDA. Some of these drugs include famotidine (Pepcid), esomeprazole (Nexium) and omeprazole (Prilosec).

Sanofi, the manufacturer of Zantac, initially recalled the drug in October 2019 from pharmacies in the U.S. and Canada because of inconsistent results found in their preliminary tests. Prior to this, certain stores like Walmart, CVS Pharmacy and Walgreens announced they wouldn’t sell Zantac over-the-counter due to the NDMA concerns.

It is the duty of drug makers to properly manufacture and distribute their drugs in a safe and ethical manner with directions for the consumer on how to use the drugs. They are also required to warn consumers of any potential risks or side effects associated with the drugs.

Common and generally minor  side effects of Zantac, for example, include:

• Itchy skin
• Rashes
• Stomach pain

• Constipation
• Diarrhea
• Nausea

• Vomiting
• Pneumonia
• Liver damage

Exposure to high levels of a probable carcinogen can now be added to the list as well. NDMA can cause:

• Cancer in human tissue
• Cramps
• Nausea

• Vomiting
• Damage to vital organs such as the bladder, kidneys, liver, lungs, pancreas and stomach

When drug makers fail to provide these risks to the consumer, manufacturers can be held legally liable for their product.

Don’t let a defective medical product or device affect your health

The Tennessee product liability lawyers at Gilreath & Associates have the experience, compassion, and commitment to listen to your case. If you or a loved one have taken Zantac and want to learn if you can receive compensation, we encourage you to call a Tennessee defective drug lawyer today for your free consultation.

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