Zantac Breast Cancer Lawsuits

If you or a loved one has been taking Zantac or generic ranitidine for heartburn, indigestion, or other related conditions, you may now be concerned about your potential for developing breast cancer.

The U.S. Food and Drug Administration (FDA) recently requested the removal of all Zantac and ranitidine products from the market because of the presence of N-nitrosodimethylamine (NDMA), a human carcinogen. Patients and consumers are understandably concerned.

Chaffin Luhana is currently investigating cases in which patients took Zantac or generic forms of ranitidine and then suffered serious injuries and/or breast cancer.

What is NDMA?

NDMA is a member of a class of chemicals called “nitrosamines” that have been qualified as potent carcinogens. NDMA was previously used to make rocket fuel, but after it was found to contaminate the air, soil, and water around manufacturing plants, NDMA’s commercial use was banned. It is now produced only for use as a research chemical.

NDMA Linked with Cancer, Including Breast Cancer

According to the WHO, “NDMA is a potent carcinogen in experimental animals by several routes of exposure, including through ingestion of drinking water.” The chemical has been classified by the International Agency for Research on Cancer (IARC) as probably carcinogenic to humans and by the U.S. Environmental Protection Agency (EPA) as a probable human carcinogen.

Other research has indicated a potential risk of nitrosamine-caused cancer. Here are some examples:

  • 2000: For a 2000 study, scientists examined data from nearly 9,000 rubber workers, following them from 1981 through 1991. Results showed that exposure to nitrosamines was significantly associated with an increased mortality rate from cancers of the esophagus, oral cavity, and pharynx, and non-significantly associated with increased mortality from prostate and brain cancer.
  • 2006: In a 2006 study, researchers noted, “Nitrosamines are known as the most potent group of carcinogens.” They went on to write that NDMA “causes liver cancer,” and that volatile N-nitrosamines “induce tumors in a variety of organs, including the tongue, esophagus, lung, pancreas, liver, kidney, and bladder.”
  • 2011: Researchers analyzed data from over 23,000 men and women, aged 40-79, who were followed for about 11 years. They found that dietary intake of NDMA was significantly associated with an increased risk of gastrointestinal cancers, particularly rectal cancer.

Some studies on nitrosamines have also taken a look at breast cancer. In a 2017 study, for example, researchers looked at nitrosamines in tobacco smoke and determined that nicotine-derived nitrosamines were related to an increased risk in breast cancer.

There is at least one human study that looked specifically at whether ranitidine and other similar heartburn medications (called “H2 blockers”) may increase the risk of breast cancer. Scientists examined data from two case-control studies involving 1,941 cases of breast cancer and 1,476 control cases (without cancer). They found that the use of cimetidine and famotidine—drugs similar to ranitidine—was not associated with an increased risk of breast cancer.  Participants using ranitidine, however, did have an increased risk hormone receptor-positive ductal carcinoma, a certain type of breast cancer. The researchers concluded that the use of H2 blockers, in general, was not linked with a risk of breast cancer, but that current use of ranitidine might be, noting that more research needed to be done.

Laboratory Tests Find NDMA in Zantac and Generic Ranitidine

Since the year 2018, the FDA has been investigating the presence of NDMA in certain medications. It started with blood pressure drugs like valsartan and losartan, some of which tested positive for the carcinogen.

In response to these and other concerning findings, on February 28, 2019, the FDA posted an updated table of acceptable daily intake limits for nitrosamine impurities. Among these was NDMA, which was listed with a new daily intake limit of no more than 96 nanograms per day— said to approximated a 1 in 100,000 cancer risk after 70 years exposure.

Shortly after that, in June 2019, online pharmacy Valisure notified the FDA that it had discovered NDMA at higher-than-acceptable levels in samples of Zantac and its generics. A few months later, on September 9, 2013, while the FDA was still focused on NDMA in blood pressure medications, Valisure sent a citizen’s petition to the agency urging it to recall all forms of ranitidine from the market. The company’s tests had detected “extremely high levels” of NDMA “in every lot tested, across multiple manufacturers and dosage forms of the drug ranitidine.”

Further, Valisure stated that the NDMA was not an “impurity” in ranitidine, as had been the case in blood-pressure drugs, but rather, a product of the instability of the ranitidine molecule itself. Wrote the petition authors, Valisure CEO David Light and Chief Scientific Officer, Kaury Kucera, Ph.D.: “The ranitidine molecule contains both a nitrite and a dimethylamine (“DMA”) group which are well known to combine to form NDMA.”

The FDA released a safety communication on September 13, 2019, warning on September 13, 2019. alerting healthcare providers and consumers that some ranitidine medications, including Zantac, were found to contain a “nitrosamine impurity” called NDMA at low levels.

The FDA stopped short of telling consumers to stop taking the drugs at that time but did note they could talk to their doctors about alternatives. Manufacturers were told to test their medications. Many of those tests were positive for the presence of NDMA. Soon generic and name-brand manufacturers were pulling their products from the market. Sanofi, the company that markets Zantac, withdrew all forms of its products from stores in October 2019.

The FDA argued, however, that according to its own tests, NDMA did not form during human digestion of ranitidine. FDA Director for the Center for Drug Evaluation and Research Janet Woodcock, M.D. issued a statement on the matter in November 2019.  The FDA had tested numerous ranitidine products on the market, she said, including tests “that simulate what happens to ranitidine after it has been exposed to acid in the stomach with a normal diet and results of those tests indicate that NDMA is not formed through this process.”  Woodcock added that “we still must test the drugs in the human body to fully understand if ranitidine forms NDMA.”

Meanwhile, Valisure stuck to its assertion that ranitidine could break down and form NDMA in the human stomach. In the petition to the FDA, the authors referred to a study conducted at Stanford University in which researchers gave participants ranitidine and measured the NDMA found in urine samples 24 hours later. The results showed that NDMA increased 400-fold from 110 to 47,600 ng after ranitidine intake, while total N-nitrosamine increased 5-fold.

The researchers stated that NDMA excretion rates “equaled or exceeded those observed previously in patients with schistosomiasis, a disease wherein N-nitrosamines are implicated as the etiological agents for bladder cancer.”

FDA Requests Removal of All Zantac and Generic Ranitidine from the Market

While the FDA continued to investigate the source of NDMA, they failed to come up with any manufacturing error or supplier problem that could explain its presence. Third-party laboratory tests, however, did show that NDMA in Zantac and ranitidine products could increase over time and when stored at higher than room temperatures.

According to an April 1, 2020 statement from the FDA: “New FDA testing and evaluation prompted by information from third-party laboratories confirmed that NDMA levels increase in ranitidine even under normal storage conditions, and NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers.”

The testing also showed that the older the product was, or the longer the period of time since it was manufactured, the greater the level of NDMA. “These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily limit,” the FDA stated.

As a result of these tests and all the other evidence concerning NDMA in ranitidine, the FDA requested the removal of all ranitidine products from the market. The FDA sent letters to all manufacturers, and also advised consumers to stop taking any ranitidine products they may currently have, dispose of them properly, and not buy more. Those needing ongoing treatment were advised to talk to their doctors about other alternatives or to explore other approved over-the-counter products.

Types of Injuries Associated with Zantac (Ranitidine)

Considering the potential exposure to NDMA, the following injuries may be associated with long-term intake of Zantac and generic ranitidine:

  • Bladder cancer
  • Stomach or gastric cancer
  • Kidney cancer
  • Liver cancer
  • Esophageal cancer
  • Pancreatic cancer
  • Prostate cancer
  • Breast cancer
  • Testicular cancer
  • Colorectal cancer (colon or rectal cancer)
  • Uterine (endometrial) cancer
  • Death

Zantac Breast Cancer Lawsuits

Many Zantac lawsuits and Zantac class-action lawsuits have already been filed in courts around the country. The plaintiffs claim that the manufacturers knew or should have known about the presence of NDMA in their products, yet they failed to warn consumers or healthcare providers.

The U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federally filed Zantac lawsuits into the Southern District of Florida on February 6, 2020. District Judge Robin L. Rosenberg was appointed to oversee the proceedings.

If you took Zantac or ranitidine regularly and were later diagnosed with breast or other forms of cancer, you may be eligible to file a Zantac lawsuit to recover damages. Chaffin Luhana is now investigating these cases and invites you to call today at 888-480-1123.