Zantac Lawsuit Alleges Recalled Heartburn Drug Caused Prostate Cancer Diagnosis

The latest lawsuit over side effects of Zantac was filed by plaintiff Jack Rhoda in the U.S. District Court for the Southern District of Florida on December 17 and alleges that his use of the recalled heartburn drug over the course of eight years caused him to develop prostate cancer. Rhoda’s claim joins a growing number of Zantac lawsuits filed by people across the country who allege that the makers of Zantac and ranitidine drugs poisoned consumers for decades by exposing them to a known carcinogen without their knowledge. If you have been diagnosed with prostate cancer or another type of cancer you believe to have been caused by your use of Zantac or ranitidine, don’t hesitate to contact a Zantac cancer attorney to discuss your legal options. With a knowledgeable attorney on your side, you may be able to recover the compensation you deserve for your alleged Zantac-related injuries and losses.

Zantac and NDMA

Zantac (ranitidine) was first approved by the U.S. Food and Drug Administration (FDA) in 1983 as a prescription heartburn medication designed to reduce the amount of acid produced by the stomach. Since its introduction, Zantac has become one of the best-selling drugs on the market and is now available in both prescription and over-the-counter formulations that are approved to treat a variety of conditions associated with too much acid in the stomach, including heartburn, acid indigestion, ulcers in the stomach and intestines, and gastroesophageal reflux disease (GERD). However, a growing body of evidence suggests that people who regularly use Zantac and ranitidine medications may face an increased risk of cancer from exposure to the cancer-causing impurity N-nitrosodimethylamine (NDMA).

Pharmacy Petitions FDA to Recall Zantac

The public wasn’t informed about the potential for Zantac to cause cancer in users until last June, when an independent pharmacy called Valisure found NDMA “in every lot tested, across multiple manufacturers and dosage forms of the drug ranitidine,” at levels that far exceed the permissible daily intake limit for NDMA established by the FDA. The CEO of Valisure, David Light, reported at that time that “Valisure’s research, along with that of Stanford University and others, found that NDMA was the result of the ‘inherent instability’ of the ranitidine molecule. This means that all manufacturers, brand or generic, and all lots of ranitidine-containing medications are affected and could generate very high levels of NDMA in the human body.”

Despite Valisure’s findings, it wasn’t until September, after the pharmacy filed a petition with the agency calling for a recall of all products containing ranitidine, that the FDA finally issued a statement alerting patients and healthcare providers about the presence of NDMA in Zantac. And even then, the FDA inexplicably downplayed the risk, indicating that “some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels.” In the months that followed the FDA’s statement, widespread Zantac and ranitidine recalls were issued by drug manufacturers throughout the United States, due to increasing concerns about NDMA exposure and cancer in Zantac users.

NDMA in Widely Used Pharmaceutical Drugs

Since 2018, the FDA has been investigating NDMA and other carcinogenic impurities in blood pressure and heart failure medications called angiotensin II receptor blockers (ARBs), which have been linked to an increased risk of cancer and liver damage. Dozens of valsartan, losartan and irbesartan medications in different combinations and from different manufacturers were found to be contaminated with the carcinogens NDMA, N-nitrosodiethylamine (NDEA) or N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) and have since been recalled. While the nitrosamine impurities in ARBs reportedly occurred as a byproduct of the manufacturing process, the NDMA found in Zantac is “likely due to an inherent instability of the ranitidine molecule,” Valisure says. According to the pharmacy, “The ranitidine molecule contains both a nitrite and a dimethylamine (‘DMA’) group which are well known to combine to form NDMA.”

Zantac Lawsuits Over Cancer Diagnoses

Over the past several months, dozens of product liability lawsuits have been filed by Zantac and ranitidine users diagnosed with stomach cancer, bladder cancer, esophageal cancer, colorectal cancer and other cancers along the digestive tract. The lawsuits all involve similar allegations that ranitidine, the active pharmaceutical ingredient in Zantac, breaks down into NDMA inside the body, thereby increasing the risk of cancer among users. As Zantac lawyers across the country continue to review and file claims throughout the coming year, it is estimated that the number of Zantac lawsuits filed nationwide will be in the thousands.

This latest Zantac lawsuit names Sanofi, Sanofi-Aventis, Boehringer Ingelheim and Chattem, Inc. as defendants, claiming that the manufacturing companies knew or should have known for decades that taking Zantac could expose users to NDMA. “When laboratory researchers want to study tumors in experimental animals, the toxin of choice to induce tumors in experimental animals is often N-Nitrosodimethylamine (NDMA),” Rhoda’s Zantac lawsuit states. “Unfortunately, the manufacturers of Zantac have been poisoning American consumers with extremely high levels of NDMA for over 35 years.”