Zantac, the popular heartburn drug used by millions of people across the country, has been at the center of a number of lawsuits filed after testing found that Zantac contains a carcinogenic chemical known as NDMA (N-nitrosodimethylamine) at levels over 3,000 times higher than the FDA-approved amount of NDMA that can be ingested safely. Several recalls have been issued since the presence of NDMA in the drugs was first discovered, including recalls by a number of generic ranitidine makers and by Sanofi, the makers of brand-name Zantac. If you or someone you love took Zantac or another ranitidine-based heartburn drug and subsequently developed cancer of the bladder, stomach, colon or kidney, contact our consumer advocates at Consumer Justice Foundation today. You may be eligible to file a Zantac cancer lawsuit and our consumer advocates can help put you in touch with a knowledgeable drug injury lawyer you can trust.
Amid increasing concerns about the potential for Zantac treatment to cause cancer, more and more people taking prescription or over-the-counter (OTC) Zantac are looking for safer alternatives to the drug. The following are some natural remedies that can help relieve heartburn, acid reflux and other similar issues caused by too much acid in the stomach:
Zantac (ranitidine) is a histamine-2 (H2) blocker used to decrease the amount of acid in the stomach, which can help relieve the symptoms of conditions like heartburn, acid reflux, acid indigestion, sour stomach, gastric and duodenal ulcers, gastroesophageal reflux disease (GERD) and Barrett’s esophagus. Zantac has been on the market in the United States since the early 1980’s and the brand-name and generic versions of the drug are routinely used by millions of people across the country. Over-the-counter ranitidine is approved to prevent and relieve heartburn associated with acid indigestion and sour stomach and prescription ranitidine is approved for the treatment and prevention of ulcers in the stomach and intestines and the treatment of GERD.
NDMA is a chemical that was once used to make rocket fuel. Today, NDMA is only produced in the United States for use as a research chemical, though it can also occur in the environment as a by-product of certain industrial processes and water disinfection. Based on results from laboratory tests, NDMA, which belongs to a family of chemicals known as N-nitrosamines, has been classified as a probable human carcinogen, meaning it could cause cancer in humans. Among the potential side effects of Zantac use are:
In addition to potentially causing cancer, NDMA is a hepatotoxin. With short-term exposure, NDMA can damage the liver, possibly leading to liver fibrosis and scarring. Long-term exposure to NDMA can increase the risk of liver, lung and kidney tumors.
The potential risk of cancer from NDMA exposure is linked to ranitidine, Zantac’s active ingredient. Although the FDA has stated that some recalled ranitidine medications were found to contain NDMA at “low” levels, these levels were actually between 3,000 and 30,000 times higher than the limit federal regulators consider “safe.” Additionally, while the FDA has suggested that the NDMA found in ranitidine samples is an “impurity,” which implies that the Zantac tablets were contaminated with the carcinogen during some part of the manufacturing process, there is growing evidence suggesting that ranitidine metabolizes into NDMA when ingested, meaning the risk appears to be in the drug itself. In fact, during the period that Sanofi and Boehringer Ingelheim were manufacturing and marketing Zantac for heartburn relief, scientific research demonstrated, among other things, that when ranitidine comes in contact with water, it sets off a chemical reaction that can result in the formation of NDMA, and that people who consume ranitidine have a 400-fold increase of NDMA concentration in their urine.
Prior to the Zantac/NDMA controversy, the FDA was investigating the presence of NDMA and other potentially harmful nitrosamine impurities in generic valsartan, losartan and irbesartan medications commonly used to treat blood pressure and heart failure. In the case of the valsartan cancer link, the FDA recommended numerous recalls after Valisure, an online pharmacy that regularly tests the drugs it sells, uncovered potentially dangerous levels of NDMA and other cancer-causing chemicals in the medications. Upon testing its ranitidine pills, Valisure found levels of NDMA in excess of 3,000,000 ng per tablet, more than 30,000 times the FDA’s established daily intake limit of 96 ng. As a result of the potential risk of cancer from NDMA exposure, ranitidine and Zantac have been recalled by several manufacturing companies, including the makers of brand-name Zantac, and a number of pharmacies, including Walgreens, CVS and Walmart, have stopped selling generic ranitidine and brand-name Zantac.
September 2019 – On the same day as the FDA’s initial Zantac NDMA warning, the first Zantac cancer lawsuit is filed in California.
September 2019 – A class action lawsuit filed in the U.S. District Court for the Northern District of California accuses Sanofi and Boehringer Ingelheim of knowingly selling Zantac containing NDMA to millions of people and deliberately concealing the potential risks of the drug.
September 2019 – A second class action lawsuit is filed against Sanofi and Boehringer Ingelheim accusing the drug makers of intentionally concealing the alleged risk of cancer from Zantac use. The lawsuit is filed in the U.S. District Court for the District of New Jersey.
June 2002 – The World Health Organization reports that NDMA is “clearly carcinogenic.”
January 2014 – The EPA reports that N-nitrosamines are “a family of potential carcinogens.”
June 2019 – Valisure detects unexpectedly high levels of NDMA in ranitidine products tested by the pharmacy’s laboratory and notifies the FDA of its findings.
September 2019 – Valisure petitions the FDA to recall ranitidine products in the United States.
September 2019 – The FDA issues a statement indicating that the carcinogenic chemical NDMA has been found in samples of ranitidine.
September 2019 – Health Canada requests that all companies manufacturing generic and brand-name versions of Zantac stop distribution of the drugs in Canada while the agency assesses the risk of harmful NDMA exposure.
September 2019 – Sandoz, the generic arm of Novartis, announces that the company will halt distribution of generic ranitidine in the United States after confirming that the capsules contain an “unexpected impurity, N-nitrosodimethylamine (NDMA).”
September 2019 – Generic manufacturer Apotex voluntarily recalls its 75mg and 150mg ranitidine tablets worldwide.
October 2019 – Sanofi announces that it is voluntarily recalling OTC Zantac in the United States due to concerns about NDMA contamination.
October 2019 – Perrigo issues a worldwide recall of all of its ranitidine products.
October 2019 – Dr. Reddy’s issues a voluntary recall of its ranitidine products in the United States, many of which are sold under store brand names, like CVS, Walgreens, Member’s Mark, Kroger and Equate.
October 2019 – Lannett Company issues a voluntary nationwide recall of its ranitidine syrup due to unexpectedly elevated levels of NDMA.
October 2019 – Novitium Pharma announces a voluntary nationwide recall of its 150mg and 300mg ranitidine capsules.
October 2019 – The FDA announces a new testing method for detecting NDMA in ranitidine products.
November 2019 – Amneal Pharmaceuticals issues a recall of dozens of lots of ranitidine tablets and ranitidine syrup amid concerns about dangerous levels of NDMA in the drug.
December 2019 – The FDA advises manufacturers to test all lots of ranitidine-based drug products for NDMA levels that are above the acceptable daily intake level approved by the FDA.
January 2020 – Denton Pharma Inc. becomes the 14th generic Zantac manufacturer to issue recall in the United States.
January 2020 – Emery Pharma warns that recent tests show that NDMA levels can increase during storage.
February 2020 – American Health Packaging adds a recall for ranitidine tablets manufactured by Amneal.
March 2020 – At this point, 15 manufacturing companies have already issued recalls for ranitidine-based drug products in the United States. Forty-three other countries have issued bans, recalls or warnings about the potential risk of cancer from NDMA contamination in Zantac.
April 2020 – The FDA calls for all ranitidine (Zantac) products to be removed from the market immediately. As a result of the recall, Zantac will no longer be available for new or existing prescriptions or OTC use in the United States. According to the FDA, “the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity.”
April 2020 – The Defense Health Agency issues a press release warning military beneficiaries not to take recalled Zantac products.
June 1987 – A study conducted by Glaxo Research Group finds no significant increase in NDMA in the stomach contents of people who take Zantac. Later, Valisure CEO David Light says that the study was not accurate, claiming that researchers used less accurate testing methods and discarded stomach samples that contained ranitidine.
February 2004 – Researchers from the National Cancer Institute find a link between ranitidine and bladder cancer. The study notes that “N-Nitrosamines are known carcinogens, and nitrate ingestion has been related to bladder cancer risk.”
December 2015 – A meta-analysis of 49 studies on dietary nitrites, nitrates and NDMA concludes that a “high” dietary level of NDMA consumption is associated with an increased risk of gastric cancer.
June 2016 – According to research published in the journal Carcinogenesis, people who consume ranitidine have a 400-fold increase of NDMA concentration in their urine.
October 2017 – A study published in the journal Chemosphere shows that ranitidine forms NDMA when placed in drinking water.
April 2019 – Research published in the journal Carcinogenesis finds that NDMA consumption is associated with an increased risk of developing pancreatic cancer.
Since Zantac was first approved by the FDA in the 1980’s, there have been numerous studies showing a potential link between ranitidine intake and cancer, including research indicating that ranitidine, when it comes into contact with water, can produce a chemical reaction that results in the formation of NDMA. Despite the fact that this research has been widely available, Sanofi-Aventis and Boehringer Ingelheim, the companies that previously held rights to Zantac, did not issue any warnings to consumers or healthcare professionals about the potential for Zantac to contain a cancer-causing chemical. Plaintiffs involved in the growing Zantac litigation are accusing the drug makers of:
Millions of people have taken Zantac and generic ranitidine to relieve heartburn, acid reflux and other similar issues, unaware that the makeup of ranitidine-based medications may put them at risk for cancer due to NDMA exposure. With countless people now suffering from bladder cancer, stomach cancer and other forms of cancer after taking Zantac, many are pursuing legal action against Sanofi and Boehringer Ingelheim, filing lawsuits to hold the drug makers accountable for their alleged negligence, their reckless disregard for human health and their willingness to put profits over people. If you took Zantac and developed cancer, you may have grounds to file a Zantac lawsuit against Sanofi and Boehringer Ingelheim in order to pursue the financial compensation you deserve for past and future medical expenses, lost wages, pain and suffering, loss of future earning capacity, loss of enjoyment of life and other damages. Contact our consumer advocates at Consumer Justice Foundation today to find out how a qualified Zantac cancer lawyer can help.