On the heels of recent recalls, both consumers and the medical community have been asking “does Zantac cause cancer?” and the answer is quite possibly yes. A small pharma lab in Connecticut discovered evidence suggesting that the active pharmaceutical ingredient (API) in ranitidine is inherently unstable and can transform into the carcinogen NDMA under the right conditions.

Heartburn medications containing ranitidine, such as Zantac, have been recalled 14 times since September. This issue is a serious concern for approximately 15 million Americans who have prescriptions for ranitidine – as well as millions of others who take a low dose over-the-counter version on a regular basis.

People who have been taking Zantac may have a number of questions: What kind of cancer does Zantac cause? How does Zantac cause cancer? And what is the Zantac cancer risk?

What Is the Zantac Cancer Risk?

A growing number of patients are coming forward with claims of Zantac cancer risk caused by the impurity known as NDMA, an abbreviation for N-Nitrosodimethylamine. NDMA is a byproduct of numerous industrial processes, including the manufacture of jet fuel. NDMA is also found in a number of food products (such as smoked meats), tobacco and certain pesticides. A potent hepatotoxin (affecting the liver), NDMA has been shown to cause tumors in several organs of the body. NDMA is considered a probable human carcinogen, or substance capable of causing cancer in humans.

How Did NDMA Get Into Prescription Drugs?

How does Zantac cause cancer? It’s not by virtue of the drug itself being carcinogenic. Instead, it’s because of contamination with the NDMA impurity.

NDMA has been found in a number of different drugs. In 2018, it was detected in a class of blood pressure medications, known as angiotensin II receptor blockers (ARBs). The U.S. Food and Drug Administration (FDA) believes NDMA contamination occurred during the manufacturing process when certain ingredients were used that were not meant to be part of the final product. Letters from the FDA to these drug makers indicate that these ingredients were not completely “purged,” or that recycled materials used in the process (solvents and catalysts) came into contact with equipment that had not been cleaned properly.

NDMA was found in ranitidine at Valisure, a small, independent testing lab for pharmaceutical products. To confirm its findings, Valisure sent a ranitidine sample to a second lab in California, Emery Pharma. Scientists at Emery not only confirmed the existence of NDMA in ranitidine, but they also found that the problem was with the molecule itself, not contamination from an outside source. It turns out that ranitidine can actually turn into NDMA when exposed to warm temperatures.

Levels of NDMA discovered in Zantac were found to be up to 26,000 times greater than the FDA-approved limit of 0.32 parts per million.

“Patients should be able to trust that their medicines are as safe as they can be and that the benefits of taking them outweigh any risk to their health,” the FDA noted in a statement issued about NDMA risk. “Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods.”

How Does Zantac Cause Cancer?

So exactly how does Zantac cause cancer? According to a toxicology review from the World Health Organization, NDMA induces cancer through a process known as biotransformation, interacting with a certain enzyme in the liver. This causes DNA mutation, which is known to be a precursor to the formation of malignant tumors.

What Kind of Cancer Does Zantac Cause?

So, what kind of cancer does Zantac cause, and what might a patient who has taken Zantac be on the lookout for? So far, Zantac has been linked with a number of different kinds of cancer due to NDMA contamination.

These include, but are not limited to:

• Stomach cancer
• Breast cancer
• Bladder cancer

How Has the FDA Responded?

In April 2020, the FDA sent letters to all manufacturers of ranitidine medications, like Zantac, asking that they voluntarily recall their products from the market immediately. The agency also advised patients to dispose of any Zantac, brand name or generic, immediately. This recall request is in response to the agency’s ongoing investigation of NDMA contamination in ranitidine, which has found that levels of the human carcinogen increase considerably if the medication is stored in higher temperatures. Even in perfect storage conditions, NDMA levels increase over time.

“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 unless its quality can be assured,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research in a statement about the recall.

Other ranitidine-free heartburn medications are still available in the marketplace.

Although the recall helps prevent undue exposure to ranitidine, Sanofi may face further liability from consumers.

Has Anyone Gotten Cancer From Taking Zantac?

For those asking, “What kind of cancer does Zantac cause?” to help determine the Zantac cancer risk they face, it may be beneficial to also take a look at the lawsuits that have been filed so far, and what cancers have been cited in these lawsuits.

As of October 2019, neither the FDA or drug manufacturers had received any adverse event reports associated with NDMA in ranitidine. A class action lawsuit filed in San Francisco in September claims that defendants Sanofi and Boehringer Ingelheim were aware of the danger and failed to warn patients.

A Zantac lawsuit was also filed in Florida by a plaintiff who claims his prostate cancer was the result of taking Zantac over a seven-year period.

An Illinois woman who alleges she developed stomach cancer after taking Zantac for about eight years has filed a lawsuit in the U.S. District Court for the District of New Jersey. She was diagnosed with stomach cancer, also known as gastric cancer, in 2019.

A class action lawsuit against Zantac has been filed by 13 plaintiffs from Maryland, Ohio, New Jersey, Ohio, West Virginia, Illinois, Colorado, Arizona and Indiana. The plaintiffs allege any patient who has consumed Zantac could be an eligible class action member. They are seeking more than $5 million for damages and for equitable action that includes medical monitoring to track their health in case they suffer cancer diagnoses in the future that are linked to NDMA.

Drug manufacturers, including Sanofi, Boehringer Ingelheim, and GlaxoSmithKline, face allegations that they sold a defective product knowing that patients would be ingesting the drug for its advertised benefits. The lawsuit alleges, “Zantac was more dangerous than the ordinary consumer, including Plaintiffs and the Class they seek to represent, would expect, and more dangerous than other alternatives (such as other anti-acids without ranitidine)…”

The lawsuit further faults the manufacturers for failing to properly test ranitidine for impurities such as NDMA, if the drugs were even tested regarding the creation of NDMA at all.

In April 2021, a Washington man filed his own lawsuit against Sanofi claiming that he developed bladder cancer in 2020 after taking Zantac since 2009. The plaintiff maintains that his cancer is a direct result of taking Zantac for over a decade.

In May 2021, even more patients took legal action against Sanofi aiming to hold the company accountable for ranitidine exposure. According to a massive new filing, Sanofi intentionally destroyed “widespread” employee emails which documented the cancer risks associated with Zantac.

Filing a Zantac Cancer Lawsuit

If you or someone you love has suffered from cancer, like stomach cancer or bladder cancer, after taking Zantac, you may be able to file a lawsuit and pursue compensation. Of course, filing a lawsuit cannot take away the pain and suffering caused by a cancer diagnosis, nor can it bring a loved one back to life, but it can at least help to alleviate the financial burden incurred by medical expenses, lost wages, and more.

Filing a lawsuit can be a daunting prospect, especially while dealing with health complications or the loss of a loved one, so Top Class Actions has laid the groundwork for you by connecting you with an experienced attorney. Consulting an attorney can help you determine if you have a claim, navigate the complexities of litigation, and maximize your potential compensation.