Lawsuits Claim Zantac Causes Cancer Due to Inherent Problems with Drug’s Active Ingredient

A growing number of Zantac cancer lawsuits allege that Zantac and other ranitidine-based drug products increase the risk of cancer in users not as a result of NDMA contamination occurring during the drug manufacturing process, but rather as a result of inherent problems with ranitidine, which can convert to NDMA in storage or as it passes through the human body. If you or a loved one took Zantac and you were subsequently diagnosed with bladder cancer, esophageal cancer, colon cancer, breast cancer or another type of cancer, contact us today to learn about the ongoing Zantac cancer litigation. You may be able to sue the makers of Zantac on the grounds that the widely used heartburn drug had a defective design and its labeling failed to warn about its serious risks.

Zantac and NDMA Exposure

Zantac (ranitidine) is a histamine-2 (H2) receptor antagonist, or H2 blocker, designed to help neutralize stomach acid. The drug has been available in the United States since the 1980s and before it was withdrawn from the market, it was one of the best-selling medications in the world, used by millions of people to treat or prevent heartburn, ulcers, gastroesophageal reflux disease (GERD), acid reflux and other conditions caused by excess acid in the stomach. Earlier this year, Zantac and other ranitidine drug products were removed from the market due to concerns about exposure to N-Nitrosodimethylamine (NDMA), a known environmental contaminant and cancer-causing substance.

NDMA Formed Due to Ranitidine’s “Inherent Instability”

The FDA has suggested that the source of NDMA in Zantac and other drugs may occur as a byproduct of the drug’s manufacturing process or changes made in the manufacturing process. However, Valisure, the online pharmacy that initially detected NDMA in ranitidine in June 2019, maintains that it is the “inherent instability” of the ranitidine molecule that makes the drug dangerous and potentially cancer-causing. According to Valisure, ranitidine’s inherent instability causes a chemical reaction when the drug is digested inside the human body, which causes the drug to metabolize into NDMA and increases the risk of cancer. If this is the case, all medications containing ranitidine, regardless of manufacturer, are affected by the problem and could put users at risk for exposure to toxic levels of NDMA, including brand-name ranitidine products like Zantac and generics.

FDA Requests Withdrawal of all Ranitidine Products

In September 2019, Valisure filed a petition with the FDA asking the agency to recall all ranitidine-containing products in light of the potential risk of cancer from exposure to NDMA. Several months later, the FDA issued a statement on new ranitidine testing results, indicating that some levels of NDMA in ranitidine products “exceed what the FDA considers acceptable for these medicines.” Unfortunately, the agency clung to its view of NDMA as an impurity sometimes found in ranitidine at low levels “similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.” It wasn’t until April 2020 that the FDA finally requested that all manufacturers immediately withdraw their prescription and over-the-counter ranitidine products from the market. In the press announcement, the FDA still described NDMA as an impurity, but admitted that “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.”

Zantac Lawsuits Follow Cancer Diagnoses

Hundreds of lawsuits are currently pending in the Zantac MDL established in federal court in Florida, all of which involve similar claims that Zantac may expose users to the carcinogen NDMA. According to allegations raised in a master complaint filed by plaintiffs in the MDL, “Ranitidine-containing products generate NDMA as the ranitidine molecule (1) breaks down in the human digestive system; (2) interacts with various enzymes in the human body; (3) reacts over time under normal storage conditions and which increases significantly when exposed to heat; and/or (4) during the manufacturing process.” The complaint goes on to say that “In aggregate, ranitidine-containing products were akin to billions of Trojan horses that smuggled dangerously high levels of NDMA into the bodies of millions of consumers.”

More than ten companies make prescription ranitidine drugs and more than 20 make over-the-counter ranitidine drugs, and many of these companies have been named in lawsuits filed by consumers who developed cancer after taking Zantac and other ranitidine medications. The lawsuits included in the growing Zantac cancer litigation allege that the drug makers knew or should have known about the inherent risks associated with ranitidine in Zantac, yet withheld this information from consumers and healthcare providers for decades. If you or someone you love developed cancer during or after Zantac (ranitidine) treatment for heartburn, GERD or acid reflux, you may qualify for a Zantac cancer claim, which can help you pursue the financial compensation you deserve from the makers of Zantac. Contact Consumer Safety Watch as soon as possible to explore your possible compensation options.