Zantac made headlines in 2019 when Valisure, an online pharmacy, informed the US Food and Drug Administration (FDA) about its dangers. Valisure reported finding large quantities of a contaminant called N-Nitrosodimethylamine or NDMA in brand-name and over-the-counter (OTC) ranitidine. As a result, the pharmacy petitioned the FDA to have Zantac recalled and suspend sales of ranitidine in the US.
Ranitidine is the active ingredient in the heartburn drug produced and sold by Sanofi under the brand name Zantac. It is a histamine-2 (H2) receptor antagonist (H2RA) available OTC and by prescription. It was a popular treatment for heartburn and acid reflux since it neutralizes excess stomach acid.
In some cases, pregnant women use it to alleviate morning sickness. Doctors also prescribed it for ulcers, Zollinger-Ellyson syndrome, and gastroesophageal reflux disease (GERD).
NDMA is a group two carcinogen present in many drugs. The Zantac recall is not the first due to large amounts of NDMA and will not be the last. It is an environmental contaminant that may be present in drinking water and food and as a by-product in several manufacturing processes. Some people believe that high levels of impurities in ranitidine may pose a significant risk to patients with Zantac cancer.
Suppose you used Zantac and believe it caused you to develop cancer. You should consult a Zantac cancer lawyer to assess if you should file a case in your state. Below are important points you should know about the possible connection between Zantac and cancer.
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Zantac and Cancer
A primary defense in personal injury lawsuits is lack of causation. Pharmaceutical companies argue the lack of scientific evidence proving the link between NDMA in ranitidine and cancer, precluding any quick settlements.
Researchers believe that in its inert state, ranitidine does not contain NDMA in significant amounts. However, based on animal studies, the World Health Organization (WHO) classifies NDMA as a probable human carcinogen. NDMA is a by-product of the breakdown of ranitidine in the stomach. Improper storage in high temperatures may also cause the process to accelerate.
The NDMA levels found in ranitidine products support the belief that users are more likely to get cancer. Below are some cancers associated with Zantac and other ranitidine products.
Researchers have long been examining the potential link between bladder cancer and ranitidine. A 2021 study suggests there is an association, depending on the duration of the therapy. People taking Zantac for less than three years are 22 percent more likely to develop bladder cancer than non-users. Those taking it for more than three years are 43 percent more at risk.
One of the earliest indications Zantac might be harmful was the results of a 2008 study. It explored the link between H2RA drugs and breast cancer, specifically famotidine, cimetidine, and ranitidine.
Results suggest ranitidine use may increase the risk of developing specific types of ductal carcinoma by at least 220 percent. Invasive ductal carcinoma is the most frequent type of breast cancer, affecting the milk ducts.
While the study did not find a link between H2 blockers and breast cancer in general, the findings raised concerns that warranted further investigation. However, pharmaceutical companies continued to sell ranitidine products until the FDA finally pulled them off the shelves nearly 12 years later.
Esophageal and uterine cancer
Ethical considerations have always restricted research on the effect of NDMA in humans to observational studies. A 2018 longitudinal study on humans indicates uncertainty over the impact of NDMA (via the heart medication Valsartan) on uterine cancer.
However, a systematic study in 1996 of patas monkeys shows a clear association between NDMA and certain cancers. Results show elevated risks of uterine (up to 13-fold) and esophageal cancer (17-fold) with exposure to NDMA and ethanol. While ethanol enhances exposure, NDMA alone is sufficient to show up in the subjects’ DNA after only four hours.
Zantac is a stomach acid blocker, so you can expect it would have some side effects involving the gastrointestinal tract. One way to measure this is through proportional reporting ratios (PRR) comparing one drug to others.
A 2021 study with NDMA-contaminated ranitidine showed increased PRRs of the stomach (1.48), pharyngeal (9.24), colorectal (16.31), and pancreatic (2.18) cancers. It compared the adverse events against other H2 antagonists.
Infant testicular cancer
Zantac and other H2RAs have been prescribed for pregnant mothers to relieve morning sickness. However, using Zantac while pregnant may lead to infant testicular cancer due to NDMA impurities.
There are no studies specific to the effect of Zantac on the development of testicular cancer in newborns. However, one case study identifies carcinogenic chemical exposure during pregnancy as a possible cause of testicular cancer in the early stages. It may manifest as tumors in the testicles later in life.
Several studies have explored the association between environmental NDMA exposure and cancer. Still, there are only a few longitudinal studies specifically investigating more invasive exposure. Since NDMA is metabolized in the liver, it is a likely candidate for a cancer site.
A 2022 cohort study using data from Taiwan linked the propensity for lung cancer to 18-year exposure to ranitidine and famotidine. Results indicate a 117 percent increase in lung cancer risk in ranitidine subjects compared to non-users.
Risk Factors for Zantac Cancer
The good news is using Zantac does not necessarily mean you will get cancer.
Early data indicated ranitidine products are only harmful when exposed to temperatures higher than room temperature, making proper storage an important preventive measure. However, it seems that the breakdown of ranitidine to produce NDMA is inevitable once ingested.
Despite the increased interest in ranitidine and cancer since the Zantac recall, there is no solid evidence of the association. However, existing data indicate some factors that may affect your cancer risk.
One is the drug’s interaction with medications such as aspirin, beta-blockers, and HBV or HCV antiviral therapy. These interactions appear to affect the absorption of NDMA positively or negatively. It is advisable to consult your physician about the possible interaction of your prescribed medications with Zantac.
Another factor is the duration of use. Valid acid reflux and peptic ulcer treatment involve 90 defined daily doses (DDDs) of 300 mg of ranitidine. Patients with low levels of Zantac (fewer than 360 DDDs) had no significant risk for liver cancer. However, those with high levels (more than 360 DDDs) were 142 percent more likely to get cancer than non-users.
Genetics, age, and lifestyle are also confounding factors for Zantac cancer. People with a family history of cancer are predisposed to develop the same type of cancer. Smokers and heavy drinkers are at high risk for lung and kidney cancer. Whether Zantac use is a contributing factor to your diagnosis has no foundation in scientific evidence to date.
Legal Actions Against Zantac
The problem with Zantac is its popularity over the years since it received FDA approval in 1984. News sources say the drug is prescribed more than 15 million times a year to help patients with stomach problems.
After pharmacies pulled all ranitidine products from the shelves, people started filing product liability lawsuits at the federal and state level. A federal judge dismissed about 50,000 cases in class action lawsuits for lack of merit. However, thousands more are pending on the state level for various H2 blockers, including Zantac.
State-level cases can prosper if the plaintiffs can prove causation, but that might require considerable powers of persuasion. Research only suggests a link between cancer and Zantac, but that is not definitive proof.
However, while plaintiffs in civil cases have the burden of proof, they do not need to meet the standards of proof beyond a reasonable doubt. Instead, they must show a preponderance of the evidence, meaning an allegation is more likely true than not.
Additionally, recent disclosures reveal that GSK, the creator of Zantac, knew of the potential for harm nearly from the start. It withheld critical data while downplaying the risks associated with the heartburn drug. This failure to warn may expose them, and any party involved in distributing and selling the product, to liability.
Nevertheless, the California state court pushed back the first Zantac cancer trial by five months. This delay gives the judge time to decide what expert testimony to accept. The lawsuit names Boehringer Ingelheim, GlaxoSmithKline (GSK), Patheon Manufacturing Services, Pfizer, and Sanofi as defendants, among others. As a bellwether case, the trial’s outcome will set the tone for other state-level cases. The new start date for the trial is July 24, 2023.
Suppose you used Zantac for a prolonged period and received a cancer diagnosis. You may be eligible to file a product liability lawsuit within the statute of limitations. Consult a Zantac cancer lawyer in your state for advice on how to get compensation for your losses.
Alternatives to Zantac
Ranitidine, including brand name and generic versions, is no longer available in the US except for research purposes. However, there are H2 blockers that do not appear to pose a risk of getting cancer.
An analysis of similar antacid drugs with active ingredients famotidine (Pepcid) and cimetidine (Tagamet) did not contain significant amounts of NDMA. Sanofi now uses a new formula for Zantac 360 that no longer contains ranitidine.
Other FDA-recommended alternatives to Zantac include proton pump inhibitors (PPIs) and natural remedies. PPIs include the following drugs:
- Nexium (esomeprazole)
- Prevacid (lansoprazole)
- Prilosec (omeprazole)
Natural remedies involve adopting diet and lifestyle practices that prevent the overproduction of stomach acid. For example, you can mitigate acid reflux by making the following changes:
- Consume smaller meals and strive for a low-fat diet
- Avoid eating a minimum of three hours before going to bed
- Engage in physical activity and avoid prolonged inactivity such as sitting and reclining
- Keep your weight at a healthy level
- Minimize alcohol and caffeine intake
- Avoid wearing tight clothes
- Stop smoking
It would be best to get a thorough evaluation and diagnosis of your condition before using any of these Zantac alternatives. While other H2 blockers and PPIs may not contain the same carcinogenic impurities as ranitidine, other considerations may exist.
For example, some of these alternatives may not interact well with your other medications. Additionally, you may suffer from other conditions requiring a different therapeutic approach. GERD, for example, is a severe form of acid reflux that requires several tests to diagnose correctly. Some cases may require surgery when medications or lifestyle changes are not enough.
Consult your doctor before changing your pharmaceutical, dietary, or physical regimen.
Did you know?
Pyrosis is the medical term for heartburn. It is a stinging sensation in the chest or throat caused by stomach acid reflux into the esophagus.
Contact a Zantac Cancer Lawyer Today
Zantac and other ranitidine products are under fire for their associated risks of developing at least 10 cancers. Current research does not establish causation, so federal courts have dismissed multidistrict litigation (MDL) cases for lack of merit.
However, available data suggests long-term use of Zantac can increase your risk of developing cancer. Moreover, drug manufacturers have known this risk for years. Still, they failed to warn the public about the potential harm of Zantac and ranitidine. As a result, they may be held liable for the losses suffered by affected individuals.
State courts have not thrown out the thousands of cases before them as more information comes to light. While no cases have gone to trial, let alone received a verdict, at least one case ended in a settlement.
You can find out more about your legal rights by checking The Personal Injury Center. We offer many informative articles about personal injury, product liability, and settlement cases, including Zantac and other products.
Suppose you want to recover damages for your cancer diagnosis from Zantac manufacturers. You should file a Zantac cancer case with the assistance of a competent product liability lawyer. Visit us for a free consultation to find one.
Pharmaceutical companies have a duty to inform you of the potential risks of their products. Visit The Personal Injury Center to learn more about product liability.
FAQs for Zantac Cancer
Many articles claim a causal link between Zantac and prostate cancer, but no studies support it. However, future research may provide insights into any potential association.
Various risk factors can affect the timeline for a cancer diagnosis in Zantac users. However, longitudinal studies suggest a range of four to eight years for long-term users.