Zantac Lawyers Previously Reviewed Cases Nationwide
Millions of Americans used Zantac (ranitidine) for heartburn and acid reflux, believing it was safe and effective. However, research later indicated that the active ingredient, ranitidine, may degrade into a toxic chemical—N-Nitrosodimethylamine (NDMA)—either during storage or inside the body, potentially increasing the risk of cancer.
Lawsuits were previously investigated for individuals who:
- Used Zantac, Zantac OTC or Generic Ranitidine;
- Exposed to the medication for at least 1 year; AND
- Diagnosed with Bladder Cancer, Esophageal Cancer, Liver Cancer, Pancreatic Cancer and/or Stomach Cancer.
Zantac Problems
Zantac (ranitidine) was introduced in 1983 as the first in a new class of medications known as H2 blockers, and was widely used to treat heartburn, acid indigestion, sour stomach, gastroesophageal reflux disease (GERD), and other conditions. Although it was marketed as safe, later findings raised serious concerns about Zantac cancer risks.
The active ingredient, ranitidine, has a molecular structure prone to instability, which may cause it to form the cancer-causing chemical N-Nitrosodimethylamine (NDMA) when exposed to heat—either during storage, transport, or inside the human body.
NDMA has long been recognized as a probable human carcinogen. Despite this, drug manufacturers failed to adequately investigate or disclose the potential cancer risks associated with Zantac use.
Zantac Recall Petition
In September 2019, the independent pharmacy Valisure filed a Citizen’s Petition (PDF) with the FDA, after testing detected high levels of NDMA in Zantac and generic ranitidine products manufactured by multiple different drug makers.
The FDA has previously determined that the permissible human intake of NDMA is only 96 ng per day. However, testing by Valisure found:
- Each 150mg Zantac tablet may produce between 2.4 million and 3.2 million ng of NDMA;
- In conditions designed to mimic breakdown in the stomach, levels of NDMA from Zantac may be 3,000x higher than the FDA daily limit
Zantac is a likely human carcinogen: The instability of ranitidine in Zantac produces NDMA in conditions that are similar to what occurs in the human body. According to the petition, there is a “compelling case for ranitidine being a likely human carcinogen.” Valisure has also sent a copy of the recall petition to the World Health Organization (WHO) and International Agency for Research on Cancer (IARC), nominating ranitidine in Zantac as a human carcinogen.
Safer Alternatives to Zantac: Due to the potential Zantac cancer risk, the petition indicates that the drug would not likely be acceptable for most, if not all, of the intended treatments. Valisure pointed out that testing of multiple Zantac alternatives did not find similar problems. No detectable NDMA levels were found for 8 different treatment options for heartburn and acid reflux, including Tagamet, Pepcid, Prilosec, Nexium, Prevacid, Protonix, AcipHex and Dexilant.
The FDA allowed individual drug makers to issue piecemeal ranitidine recalls for months, before finally issuing a recommendation to remove all versions of brand-name Zantac, over-the-counter (OTC) and generic equivalents on April 1, 2020.
Zantac Cancer Side Effects
N-Nitrosodimethylamine (NDMA) in Zantac may increase the risk of cancer among humans exposed to high levels over a short-term, or low levels over a long-term. The dangers of this chemical have been known for more than 40 years.
The typical Zantac dose for treatment of peptic ulcer disease includes a 150mg tablet twice daily for 4 to 8 weeks, and maintenance doses typically involve one 150mg tablet per day. Given the chronic nature of heartburn and indigestion, many users continue to take Zantac long-term.
Following a number of valsartan recalls issued in 2018, after NDMA contaminated the widely used blood pressure drug, the FDA determined that the permissible intake of NDMA is 96 ng per day (35,000 ng over the course of a year).
- Typical 8-week Zantac treatment for peptic ulcer disease may expose users to 280 million ng of NDMA (8,000x higher than FDA permissible levels for a year);
- Continued maintenance use of one Zantac 150 mg tablet per day may expose users to 889 million ng of NDMA over the course of a year (25,400x higher than FDA annual permissible levels)
While users are discovered the potential link between Zantac and cancer side effects, information suggests that the drug makers knew or should have known about this risk for years.
Zantac NDMA Exposure
The first scientific articles suggesting that Zantac resulted in NDMA appeared within a few years after the drug was introduced, and multiple studies have demonstrated that ranitidine in Zantac has a strong potential to form NDMA under certain conditions.
In March 2016, Stanford researchers published a study in the medical journal Carinogensis, which found dangerous levels of NDMA in the urine of individuals taking Zantac.
The study involved testing of urine from 10 healthy volunteers, analyzing NDMA levels before and after consumption of Zantac (ranitidine) 150mg tablets. Researchers found a 400x increase in NDMA from Zantac. In addition, due to metabolism within the body, these measurements likely represent low estimates of the systemic NDMA exposure from Zantac.
The findings highlighted the need for additional studies to better evaluate the cancer risk, particularly bladder cancer from Zantac based on the NDMA excretion rates.
Timeline of Zantac Risks
1983
Glaxo introduces Zantac and aggressively markets the heartburn drug, which becomes the first to break $1 billion in sales by 1986.
1983
Early research involving rats indicates that that Zantac may react with nitrates in the stomach to create NDMA, which has been linked to cancer risks since the 1970s.
1991
Study finds dose and time relationship between NDMA exposure and liver tumors in rats.
2004
National Cancer Institute study examines bladder cancer risk with peptic ulcer disease.
March 2016
Study published by Stanford researchers found NDMA excretions in urine increase 400-fold after taking Zantac.
September 2019
Citizen petition is filed with the FDA, calling for a Zantac recall after testing by a pharmacy found massive amounts of NDMA in each tablet. Days later, the FDA issued the first public warnings about NDMA in Zantac and generic ranitidine.
April 2020
The FDA recommended that all Zantac and ranitidine drugs be removed from the market, after confirming NDMA levels may increase while the drug is in storage.
Allegations Raised in Zantac Recall Lawsuits
The lawyers at Saiontz & Kirk, P.A. previously investigated potential Zantac class action lawsuits and individual claims involving cancer diagnoses linked to ranitidine use. Allegations raised in the litigation included claims that pharmaceutical companies:
- Failed to properly research the side effects of Zantac before introducing the drug;
- Knew or should have discovered that Zantac exposes users to unsafe levels of the carcinogen NDMA;
- Failed to warn about the potential cancer risk from Zantac;
- Failed to promptly issue Zantac recalls or safety warnings for users and the medical community;
No Fees or Expenses Unless a Zantac Settlement Was Recovered
Saiontz & Kirk, P.A. is a nationally recognized injury law firm dedicated solely to representing individuals—not corporations or insurance companies.
For more than 40 years, our clients have recovered over $1 billion in compensation across a wide range of personal injury cases, including product liability, medical malpractice, and auto accidents.
Zantac injury cases were handled on a contingency fee basis, with no out-of-pocket costs to hire our lawyers. Fees and expenses were only collected if a recovery was obtained.
Our team previously helped individuals and families explore their legal options following a cancer diagnosis potentially linked to Zantac or ranitidine use.
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