Zantac Lawyers Reviewing Cases Nationwide
Millions of Americans have taken Zantac (ranitidine) for treatment of heartburn and acid reflux. While drug makers indicated that this was a safe and effective drug, evidence it has been discovered that the active ingredient ranitidine may convert to a toxic chemical during storage or inside the body, exposing users to a cancer risk from Zantac side effects.
- 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.
The lawyers at Saiontz & Kirk, P.A. provide free Zantac case evaluations to help individuals and families throughout the United States determine whether they may have a claim. There are never any out-of-pocket costs to hire our Zantac lawyers, and we only receive an attorney fee or expenses if a recovery is obtained.
Zantac was introduced in 1983, as the first member of a new class of medications, known as histamine H2-receptor antagonists (H2 blockers). It has been widely marketed as a safe treatment for heartburn, acid indigestion, sour stomach, gastroesophageal reflux disease (GERD) and other conditions. However, it now appears that Zantac side effects may carry serious cancer risks.
The active ingredient in Zantac is ranitidine, which has an inherent molecular structure that may react with itself. This can produce dangerous levels of the chemical N-Nitrosodimethylamine (NDMA) when exposed to high temperatures inside the human body or during transport (such as in a hot car).
For decades, NDMA has been known to increase the risk of cancer in humans. While the drug makers knew or should have known about the link between Zantac and cancer, they failed to adequately research the risk or warn users and the medical community.
Following exposure for only a few months, experts indicate that NDMA may result in the development of cancer from Zantac. To find out if you or a loved one may have a case, request a free consultation and claim evaluation.
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 just now discovering 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
Glaxo introduces Zantac and aggressively markets the heartburn drug, which becomes the first to break $1 billion in sales by 1986.
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.
Study finds dose and time relationship between NDMA exposure and liver tumors in rats.
National Cancer Institute study examines bladder cancer risk with peptic ulcer disease.
Study published by Stanford researchers found NDMA excretions in urine increase 400-fold after taking Zantac.
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.
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. are reviewing potential Zantac class action lawsuits and individual claims for individuals diagnosed with cancer. According to allegations that will be presented, the pharmaceutical companies manufacturing the popular heartburn drug have:
- 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 You Receive a Zantac Settlement
Saiontz & Kirk, P.A. is a nationally known injury law firm that is focused exclusively on representing individuals, we do not represent corporations or insurance companies.
Over the course of more than 40 years, clients of our law firm have collected more than $1 billion in compensation in cases involving product liability, medical malpractice, automobile accidents and other personal injury lawsuits.
All Zantac injury cases are being handled on a contingency fee basis, which means that there are never any out-of-pocket costs to hire our lawyers and we receive no fees or expenses unless a recovery is obtained.
Protect your family and find out if you or a loved one may be entitled to a Zantac cancer settlement.