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Zantac — a heartburn medication considered safe enough to be sold over the counter — has tested positive for a cancer-causing chemical. The discovery has led to a U.S. Food and Drug Administration (FDA) investigation and subsequent recall of Zantac and its generics.

The possibility that a drug used by millions of patients could cause cancer is deeply troubling. Our attorneys are prepared to file lawsuits on behalf of Zantac users diagnosed with cancer. If you or a family member takes Zantac, you may want to consider treatment alternatives and speak with an attorney about possible legal action.

What’s the Problem With Zantac?

The antacid drug ranitidine, commonly sold under the brand name Zantac, was found to contain N-Nitrosodimethylamine (NDMA), a chemical classified as a probable carcinogen by the FDA, Environmental Protection Agency, and World Health Organization. According to the Centers for Disease Control (CDC), NDMA has been linked to severe liver disease, liver cancer, and lung cancer.

Although human testing is limited, the CDC said, “exposure to NDMA by eating, drinking, or breathing could cause cancer in humans.” Harvard Medical School noted that NDMA “may cause cancer only after exposure to high doses over a long period of time.” NDMA has also been found in blood pressure medications such as Valsartan. It is commonly used in pesticides and rocket fuel.

How Was NDMA Discovered in Zantac?

The impurity was discovered by Valisure, a Connecticut-based online pharmacy. According to Valisure, its testing found “extremely high levels” of NDMA in every lot of ranitidine it tested across multiple manufacturers and dosages. Valisure detected more than 3,000,000 nanograms of NDMA per tablet — an amount more than 31,000 times higher than the FDA’s permissible daily intake of 96 nanograms.

In a citizen petition to the FDA, Valisure requested that the agency request a recall and suspend sales of ranitidine from the U.S. market. The FDA announced that its own preliminary testing has detected NDMA in ranitidine but at levels lower than those detected by Valisure. The FDA is continuing its testing and has asked manufacturers to conduct their own. David Light, CEO of Valisure, said: “There’s no acceptable cancer risk for a drug like this.”

Has Zantac Been Recalled?

Yes. In April 2020, the FDA ordered a recall of all ranitidine products. This was after multiple manufacturers had already issued voluntary recalls of the drug. These drug-makers included Sanofi, the maker of brand-name Zantac, as well as generic ranitidine-makers Apotex, Novartis, and Dr. Reddy’s Laboratories. In addition, major pharmacy chains CVS, Walgreens, and Walmart had already suspended sales of Zantac and its generic versions because of the drug's link to cancer.

NDMA has been linked to severe liver disease, liver cancer, and lung cancer.

Should I Stop Taking Zantac?

Yes. The FDA has advised that individuals stop taking ranitidine and speak with their healthcare provider about other treatment options. A number of alternatives are available: FDA testing of Zantac competitors such as Pepcid, Tagamet, Nexium, Prevacid, and Prilosec has shown no NDMA in these medicines.

What Is the Cause of NDMA Found in Zantac?

Valisure, the laboratory that first detected NDMA in ranitidine, theorizes that the contaminant was the result of the “inherent instability” of the ranitidine molecule. This is a potentially different source of NDMA than what was discovered in drugs like Valsartan, which were contaminated through manufacturing flaws at plants in China and India.

Did Drugmakers Know About the Problem?

Peer-reviewed studies published on the topic of ranitidine and NDMA suggest that Sanofi and other drugmakers knew — or should have known — that Zantac use potentially exposes users to NDMA.

For example, a study published in the journal Carcinogenesis found that patients taking ranitidine had a 400-fold increase of NDMA concentration in their urine. Other studies, including those published in Chemosphere and Environmental Science{ :target="_blank"} & Technology, have shown that ranitidine is a possible NDMA precursor (in chemistry, a precursor is a substance from which another substance is formed).

Medicinal chemist Wolfgang Hinz provided a statement to Valisure about NDMA formation risk from ranitidine. He explained, “Both chemical components and precursors of NDMA — nitrite (“N”) and dimethylamine (“DMA”) — are present in the ranitidine molecule,” and “once liberated, the N and DMA could combine in physiological conditions to form NDMA.”

Valisure further wrote in its FDA petition, “Since 2002, the formation of NDMA by the reaction of DMA and a nitroso source (such as nitrite) has been well characterized in the scientific literature.”

Was Sanofi aware of these scientific findings, and if so, why did it fail to inform the public? These questions will feature prominently in our attorneys’ lawsuit investigation.

Who Can File a Zantac Lawsuit?

Anyone who has taken Zantac or generic ranitidine and been diagnosed with cancer may be eligible for legal action against manufacturers. In February 2020, 15 Zantac lawsuits were consolidated into a multidistrict litigation (MDL) and moved forward to a South Florida court.

There are currently over 125 Zantac lawsuits pending in 21 districts across the country.

Drugmakers knew — or should have known — that Zantac use potentially exposes users to NDMA.

What Can I Recover From a Zantac Lawsuit?

Economic damages — including past and future medical bills, and lost earnings — as well as noneconomic damages for losses such as physical and mental pain and suffering are potentially available from a Zantac lawsuit. The actual compensation a plaintiff is eligible to receive depends on the specific details of their case.

How Can a Lawyer Help?

Pharmaceutical companies have virtually endless resources to spend on legal defense. Sanofi, for example, has annual revenue of nearly $40 billion. To have the best chance at being fairly compensated, you should work with a law firm that has the experience and resources needed to stand up to Big Pharma. With more than 500 attorneys, Morgan & Morgan is one of the few firms in the country that can successfully challenge Big Pharma in the courtroom — and our results prove it.

How Do I Know if I Have a Case?

If you were diagnosed with cancer after using Zantac OTC or a generic equivalent, our attorneys may be able to help you. For a free legal consultation, call 877-378-3148 or submit a case review form. It costs nothing to get started, and we get paid only if your case is successful.


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