Zantac—a drug considered safe for decades—may carry previously-undisclosed cancer risks from the carcinogen N-nitrosodimethylamine (NDMA). This is the same contaminant that has been found in blood pressure medications such as Valsartan.
While it’s still unknown how Zantac is contaminated with NDMA, the finding has prompted numerous voluntary recalls, as well as stores pulling the drug from their shelves. The FDA’s investigation of the issue is ongoing. Alarmed by the potential impurities in their heartburn medication, users of Zantac and its generic equivalents are also filing lawsuits that claim Sanofi knew—or should have known—about NDMA cancer risks. Our attorneys are investigating Zantac cancer claims and invite you to contact us for a free legal consultation.
Zantac Approval History
Zantac has been on the market for nearly four decades, first as a prescription drug to treat ulcers, and more recently as an over-the-counter (OTC) medication for heartburn.
Glaxo Holdings (now GlaxoSmithKline) launched Zantac as a competitor to the highly-successful ulcer drug Tagamet, which was introduced in 1975. Originally sold in Britain and Italy in 1981, Zantac first obtained U.S. FDA approval in 1983. In 1988, Zantac became the world’s best-selling drug and one of the first drugs to reach $1 billion in sales.
When Glaxo’s ranitidine patents expired in 1997, generics began to hit the market. Beginning in 2004, over-the-counter versions of Zantac were approved to treat heartburn. Zantac is still prescribed by doctors to treat conditions such as stomach ulcers, gastroesophageal reflux disease (GERD), and conditions in which the stomach produces excessive acid. Some versions of the drug are prescribed to children and babies. According to WebMD, doctors write more than 15 million ranitidine prescriptions annually, in addition to the countless patients who buy it over-the-counter, without a prescription.
How Does Zantac OTC Work?
Ranitidine belongs to a class of drugs called histamine-2 (H2) blockers. H2 receptors in the stomach lining are normally acted upon by histamine—a naturally occurring chemical that stimulates H2 receptors and causes cells in the stomach to produce acid to aid food digestion. Ranitidine blocks H2 receptors, thus reducing the production of stomach acid. This can relieve symptoms associated with indigestion, reduce the backflow of acid into the esophagus, and allow ulcers to heal.
Zantac Recalls and FDA Investigation
On September 9, 2019, online pharmacy Valisure sent an FDA citizen petition requesting that the agency request a recall and suspend sales of all lots of all products containing ranitidine from the US market. Valisure explained that its testing had revealed “extremely high levels” of NDMA “in every lot tested, across multiple manufacturers and dosage forms.” Valisure reportedly detected NDMA at levels more than 31,000 times higher than the FDA’s permissible NDMA daily intake.
FDA subsequently issued a statement announcing an investigation into the issue. Since then, Sanofi and generic ranitidine manufacturers have issued voluntary recalls. You can see the full list of recalled ranitidine products here. In addition, CVS, Walgreens, and Walmart have suspended sales of generic and brand name Zantac.
On November 1, 2019, FDA provided an update on its investigation. It stated that its own testing showed NDMA levels in ranitidine products much lower than the levels initially reported by Valisure, but that “some levels still exceed what the FDA considers acceptable for these medicines.”
How Did Zantac Become Contaminated With NDMA?
It’s not yet clear why NDMA impurities have been found in ranitidine drugs. Valisure’s scientists believe that it is due to the ranitidine molecule, which contains both a nitrite (N) and a dimethylamine (DMA) group that can combine to form NDMA.
“Our finding is that this is an inherent instability of the ranitidine molecule. It just falls apart into NDMA,” said David Light, CEO of Valisure. “And this isn’t just Valisure yelling about something we happened to find. The foundation of this concern has been around for decades. We’re really just connecting the dots.”
Others say that the issue has to do with the manufacturing. This was the case with blood pressure drugs that were contaminated due to problems at plants in China and India. FDA spokesperson Jeremy Kahn told Everyday Health that the ranitidine contamination issue is related to manufacturing, not the ranitidine molecule. “If it had been a problem with the molecule, we would have seen the negative effects a long time ago,” said Kahn.
Am I At Risk If I Take Zantac?
FDA says that the levels of NDMA it found in ranitidine are similar to the levels one would expect to be exposed to from eating common foods like grilled or smoked meats. However, Valisure’s David Light said in a video that, based on the amounts of NDMA its testing found in ranitidine, “To have 3 mg of carcinogen being able to be formed by ranitidine is extremely concerning to us.”
The level of concern for patients is based not only on the amounts of NDMA in ranitidine but also on how long they take Zantac. Gastroenterologist Emeran A. Mayer notes that there is greater possible risk for patients who use ranitidine on a long-term basis (more than a month) than for patients who use the drug on a short-term basis.
The symptoms of NDMA overexposure include yellowing of the skin, nausea, fever, vomiting, abdominal cramps, and dizziness. High levels of NDMA exposure can cause reduced kidney and lung function. Animal testing links NDMA to liver disease, liver damage, liver cancer, testicular cancer, and lung cancer, and birth defects.
What Should I Do Next?
If you take Zantac and experience side effects of NDMA poisoning, talk to your doctor right away. Even if you don’t have symptoms, the FDA recommends that patients speak with their healthcare provider about other treatment options, as there are a number of ranitidine alternatives that have not tested positive for NDMA.
Anyone who has suffered cancer or other health complications linked to Zantac and NDMA may also wish to speak with an attorney about their legal options. Zantac’s manufacturers never mentioned the potential NDMA risk posed by Zantac products, despite the fact that, for years, ranitidine has been implicated as a cause of NDMA formation by multiple research groups.
As more facts come to light about the link between Zantac and cancer, our attorneys stand ready to file lawsuits on behalf of affected patients. Schedule your free case review.