Amid increasing concerns about the safety of Zantac, an Ohio woman claims in a new product liability lawsuit that side effects of the popular heartburn drug, used by millions of people in prescription and over-the-counter form, caused her to develop stage IV kidney cancer. Zantac is the latest in a string of medications that have been linked to N-nitrosodimethylamine (NDMA) a cancer-causing chemical associated with an increased risk of kidney cancer, bladder cancer, stomach cancer, liver cancer and other serious medical problems. Unlike valsartan and other drugs that have been recalled recently due to an NDMA contamination, a growing body of evidence suggests that the issue with Zantac is its active ingredient, ranitidine, which may convert to NDMA when it is digested by the human body.
Zantac (ranitidine) entered the market in the United States in 1983 as the first in a class of medications known as histamine H2-receptor antagonists, or H2 blockers. These medications are used to reduce the amount of acid produced by the stomach in order to treat and prevent heartburn, ulcers in the stomach, gastroesophageal reflux disease (GERD) and other similar conditions. Unfortunately, in light of evidence suggesting that ranitidine can convert to NDMA in the body, the millions of people who regularly use the antacid to prevent and treat these conditions may be at risk for cancer from exposure to the cancer-causing chemical.
Doctors write more than 15 million prescriptions for ranitidine every year and countless more people buy the product over the counter to relieve symptoms of heartburn and acid reflux. And many of these people are now pursuing lawsuits against the makers of Zantac and generic ranitidine products, alleging that the medications caused them to develop cancer due to exposure to NDMA. According to allegations raised in this latest Zantac lawsuit, filed by Sandra J. Payne in the U.S. District Court for the Northern District of Ohio, NDMA has been in Zantac since it first entered the market in the early 1980s. “Going back as far as 1981, two years before Zantac entered the market, research showed elevated rates of NDMA, when properly tested. This was known or should have been known by Defendants,” the lawsuit states. Still, Boehringer Ingelheim and Sanofi continued to promote the drug as a safe and effective treatment for heartburn, acid indigestion and GERD, while actively concealing or downplaying the potential risk of cancer-related side effects.
Sandra Payne took two Zantac pills each day for 12 years and earlier this year, she was diagnosed with renal cancer resulting in the need for kidney removal surgery. She alleges in her claim that the makers of Zantac, Boehringer Ingelheim and Sanofi, and other makers of generic ranitidine products withheld information about the potential for Zantac’s active ingredient, ranitidine, to convert to NDMA when ingested.
Payne’s lawsuit comes in the wake of a number of Zantac and ranitidine recalls issued after independent testing by an online pharmacy called Valisure found “extremely high” levels of NDMA “in every lot tested, across multiple manufacturers and dosage forms of the drug ranitidine.” In June 2019, Valisure notified the FDA of its findings and in September 2019, the pharmacy filed a petition with the FDA calling for a recall of all versions of Zantac. According to the petition, Valisure detected NDMA in ranitidine products in excess of 3,000,000 ng per tablet, more than 30,000 times the permissible daily intake limit of 96 ng per tablet established by the FDA.
In adjusting its testing methods to mimic the conditions present inside the human stomach, Valisure still found NDMA in ranitidine at levels 3,000 times higher than the FDA’s permissible daily limit. The independent pharmacy concluded in its petition that the NDMA in Zantac is “likely due to an inherent instability of the ranitidine molecule. The ranitidine molecule contains both a nitrite and a dimethylamine (“DMA”) group which are well known to combine to form NDMA.” In other words, ranitidine can react with itself inside the body to produce NDMA, which, the pharmacy notes, “builds a compelling case for ranitidine being a likely human carcinogen.”
Just days after Valisure petitioned the FDA to recall Zantac and ranitidine products in the United States, the agency issued an official statement alerting patients and healthcare providers to the presence of NDMA in ranitidine. In the statement, the FDA noted 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,” which appears to be in direct contradiction to Valisure’s findings of NDMA at levels between 3,000 to 30,000 times what the FDA considers safe. The FDA stopped short of issuing a Zantac recall, but noted that people taking over-the-counter ranitidine products could “consider using other OTC medicines approved for their condition.”
Since the link between Zantac and NDMA was made public in September, many lawsuits have been brought against the makers of Zantac, all involving similar allegations that plaintiffs developed bladder cancer, kidney cancer, stomach cancer, esophageal cancer, colorectal cancer or other cancers affecting the digestive tract as ranitidine broke down inside their bodies. If you or someone you love has been diagnosed with cancer and you believe NDMA exposure from Zantac to be the cause, contact an experienced Zantac cancer attorney as soon as possible to discuss your possible compensation options.