Zantac FAQ

Zantac FAQ

Zantac Cancer-Causing Issue Explained

Does Zantac Cause Cancer?

Yes, Zantac can cause cancer. Zantac’s active ingredient, ranitidine, produces high levels of N-Nitrosodimethylamine (NDMA). The U.S. Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and the World Health Organization (WHO) classify NDMA as a cancer-causing chemical.

IMPORTANT ZANTAC (RANITIDINE) UPDATE: On April 1, 2020, the U.S. Food and Drug Administration announced that drug makers are to immediately withdraw all Zantac and generic Zantac OTC medications from the market. The FDA determined that N-Nitrosodimethylamine (NDMA) in some ranitidine drugs “increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels…” NDMA is classified as a known carcinogen by theEnvironmental Protection Agency (EPA), the World Health Organization (WHO), and the FDA.

The ranitidine molecule contains both a nitrite and a dimethylamine (DMA) group. These combine to form NDMA. Put simply, ranitidine produces NDMA by “react[ing] with itself,” according to online pharmacy Valisure, which conducted testing on Zantac 150 mg tablets using FDA-approved methods. This means that every dosage and form of ranitidine, including Zantac, exposes users to NDMA.

You don’t have to take our word for it. Below are some of the studies linking cancer and NDMA:

NDMA Cancer Human Epidemiological Studies

Several human epidemiological studies have found a link between NDMA and various forms of cancer:

1995 A case-control study investigating NDMA dietary exposure with 220 cases found a statistically significant 700% increased risk of gastric cancer in persons exposed to more than 0.51 ng/day.

1995A case-control study investigating NDMA dietary exposure with 746 cases found statistically significant elevated rates of gastric cancer in persons exposed to more than 0.191 ng/day.

1995A case-control study looking at, in part, the effects of dietary consumption on cancer, found a statistically significant elevated risk of developing aerodigestive (respiratory and digestive tracts) cancer after being exposed to NDMA at .179 ng/day.

1999A cohort study examining NDMA dietary exposure with 189 cases and a follow up of 24 years found that “N-nitroso compounds are potent carcinogens” and that dietary exposure to NDMA more than doubled the risk of developing colorectal cancer.

2000A cohort study looking at occupational exposure of workers in the rubber industry observed significant increased risks for NDMA exposure for cancer of the brain, esophagus, oral cavity, pharynx, and prostate.

2011A cohort study investigating NDMA dietary exposure with 3,268 cases and a follow up of 11.4 years concluded that “[d]ietary NDMA intake was significantly associated with increased cancer risk in men and women” for all cancers, and that “NDMA was associated with increased risk of gastrointestinal cancers,” including rectal cancers.

2014A case-control study looking at NDMA dietary exposure with 2,481 cases found a statistically significant elevated association between NDMA and colorectal cancer.

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NDMA Cancer Animal Studies

NDMA has also been linked to cancer in animal studies:

  • In mouse studies investigating NDMA’s cancer-causing potential through oral administration, animals exposed to NDMA developed cancer in the kidney, bladder, liver, and lung.
  • In similar rat studies, cancers were observed in the liver, kidney, pancreas, and lung.
  • In similar hamster studies, cancers were observed in the liver, pancreas, and stomach.
  • In similar guinea-pig studies, cancers were observed in the liver and lung.
  • In similar rabbit studies, similar cancers were observed in the liver and lung.
  • In other long-term animal studies in rats and mice using different exposure routes (inhalation, subcutaneous injection, and abdominal injection), researchers observed cancer in the kidney, liver, lung, nasal cavity, and stomach.

What Is Behind the Zantac and Cancer Scare ? 

In 2019, an online pharmacy company called Valisure conducted testing of Zantac and other ranitidine products using FDA-approved methods. In every lot tested, the company found exceedingly high levels of NDMA.

Valisure’s testing found, on average, greater than 2,600,000 ng of NDMA in a Zantac 150 mg tablet. The FDA’s permissible daily limit for NDMA is 96 ng, which means the level of NDMA in Zantac is roughly 28,000 times the legal limit.

To put this in some perspective, a person would have to smoke at least 6,200 cigarettes to achieve the same levels of NDMA found in one 150 mg dose of Zantac.

Concerned that the extremely high levels of NDMA observed in its first round of testing were a product of the heating process in the testing protocol, Valisure retested Zantac tablets in conditions simulating the human stomach. Under these biologically relevant conditions, astonishingly high levels of NDMA were found in one dose of Zantac 150 mg, ranging up to 3,100 times above the FDA’s daily allowable limit.

In terms of smoking, a person would have to smoke over 500 cigarettes to achieve the same levels of NDMA found in a Zantac 150 mg tablet.

Why Is Zantac Being Recalled?

After the online pharmacy company Valisure alerted the U.S. FDA to exceedingly high levels of a cancer-causing chemical called NDMA in Zantac, several generic drug makers and retailers decided to issue Zantac recalls. While the reasoning behind each company’s decision to issue a recall varies, it is clear that high levels of NDMA found during testing at a minimum warranted further investigation.

In October of 2019, weeks after Valisure reported its Zantac testing results, the FDA issued a statement ordering all Zantac (ranitidine) manufacturers to conduct testing for NDMA as preliminary results indicated unacceptable levels of NDMA in Zantac. More companies, including GlaxoSmithKline (GSK) and Teva Pharmaceuticals, decided to issue recalls following the FDA’s statement.

Which Zantac Is Recalled?

To stay as up to date as possible on which Zantac (ranitidine) products have been recalled, we advise you to consult the FDA’s Recalls, Market Withdrawals, & Safety Alerts page.

As of November 2019, the following companies have recalled ranitidine products:

  • Golden State Medical Supply
  • Amneal Pharmaceuticals
  • American Health Packaging
  • Aurobindo Pharma USA
  • Perrigo Company
  • Novitium Pharma
  • Lannett Company
  • Dr. Reddy’s Laboratories (this includes Zantac over-the-counter OTC medicines labeled by retailers such as Walgreens, Walmart, CVS, Target, and Kroger)
  • Sanofi
  • Apotex Corp. (this includes over-the-counter ranitidine tablets 75 mg and 150 mg, labeled by Walgreens, Walmart, and Rite-Aid)
  • Sandoz
  • GlaxoSmithKline (GSK)

Is Zantac Contaminated?

No, we do not believe impurities or contaminants during manufacturing are what is causing the Zantac issue. The high levels of NDMA in Zantac are inherent to the molecular structure of ranitidine, meaning the drug is defective by design.

Our firm believes the FDA’s stance on Zantac falls well short of safely addressing a serious threat to consumers. By saying the presence of NDMA in Zantac is an “impurity,” the agency is choosing to protect the drug makers instead of protecting the public.

NDMA: What Is It?

N-Nitrosodimethylamine (NDMA) is a semi-volatile organic chemical that forms in both industrial and natural processes. NDMA was formerly used in production of rocket fuel, additives for lubricants and softeners for copolymers and antioxidants. Today, NDMA is exclusively used in the U.S. for research purposes.

The U.S. Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and the World Health Organization (WHO) all classify NDMA as carcinogen (a substance capable of causing cancer).

NDMA is a member of N-nitrosamines, “a family of potent carcinogens,” according to the EPA. The WHO maintains that “NDMA is clearly carcinogenic. There is overwhelming evidence that NDMA is mutagenic and clastogenic.”

The science behind NDMA and cancer is not new: a news article published in the late 1970s noted that “NDMA has caused cancer in nearly every laboratory animal tested so far.”

Which Cancers Are Associated with Zantac NDMA?

Our firm is filing Zantac lawsuits on behalf of victims diagnosed with the following forms of cancer after taking Zantac (ranitidine hcl):

Bladder cancer
Colorectal cancer
Esophageal cancer
Intestinal cancer
Kidney cancer
Liver cancer
Lung cancer (for non-smokers)
Ovarian cancer
Pancreatic cancer
Prostate cancer
Stomach cancer
Testicular cancer
Thyroid cancer
Uterine cancer

If you are unsure whether you are eligible to file a Zantac lawsuit, we recommend you give us a call and allow us to perform a free case review.

Zantac Information

Should I Stop Taking Ranitidine?

Yes. While the FDA continues to protect drug makers instead of the general public by failing to pull Zantac from the shelves, people should consult with their physicians about finding a suitable alternative.

Is There a Safe Zantac Dosage?

No. The high levels of NDMA in Zantac should deter patients from taking the medication. With several safe alternatives, consult with your physician about what Zantac substitute is best for you.

Is There a Good Substitute for Zantac?

Yes, there are several good alternatives to Zantac. Zantac substitutes like Nexium (esomeprazole), Pepcid (famotidine), Prevacid (lansoprazole), Prilosec (omeprazole), and Tagamet (cimetidine) show no NDMA during testing. Pepsid and Tagament are good options for chemotherapy patients who were prescribed Zantac or Zantac OTC to control acid reflux, heartburn, and gastrointestinal reflux disease (GERD).

What Are the Most Common Ranitidine Zantac Side Effects?

Aside from the link to cancer, Zantac (ranitidine hcl) has several known side effects.

For adults, the most common ranitidine side effects include:

  • Dizziness
  • Constipation
  • Blurred vision
  • Headache
  • Uncommon bleeding/bruising
  • Vertigo
  • Fatigue
  • Infection
  • Rashes
  • Difficulty sleeping
  • Tachycardia
  • Bradycardia
  • Thrombocytopenia
  • Atrioventricular block
  • Premature ventricular beats
  • Vitamin B12 deficiency
  • Diarrhea
  • Liver failure
  • Hepatitis
  • Jaundice
  • Pneumonia

For the elderly or seriously ill, the most common Zantac ranitidine side effects are:

  • Confusion
  • Agitation
  • Depression
  • Hallucinations

For children, the most common side effects associated with ranitidine include:

  • Headaches
  • Constipation
  • Diarrhea
  • Nausea
  • Vomiting
  • Rashes