Lawsuit Alleges NDMA Exposure from Zantac Led to Colon Cancer Diagnosis

A Florida woman indicates in a new product liability lawsuit that using the recalled heartburn drug Zantac for 10 years caused her to develop colon cancer due to exposure to the probable human carcinogen N-Nitrosodimethylamine (NDMA). The lawsuit, filed in the U.S. District Court for the Southern District of Florida by Cynthia Minkley, alleges that the NDMA found in Zantac is the result of the way ranitidine, the drug’s active ingredient, breaks down in the human body, and that exposure to NDMA is what caused her cancer. If you have been diagnosed with colon cancer or another type of cancer and you believe NDMA exposure from Zantac or ranitidine treatment to be the cause, consult a qualified product liability lawyer today. You may qualify for financial compensation through a Zantac cancer claim and a knowledgeable Zantac injury attorney can help.

Link Between Zantac and Cancer

Zantac, known generically as ranitidine, was once considered one of the best-selling drugs in U.S. history, used by millions of people across the country to treat and prevent heartburn, acid indigestion, ulcers of the stomach and intestines, gastroesophageal reflux disease (GERD) and other conditions occurring when the stomach produces too much acid. Zantac belongs to a class of drugs known as histamine-2 (H2) blockers and the medication works by blocking the pumps in the stomach that produce acid in response to histamine, thereby providing relief of the burning and discomfort associated with heartburn and other similar conditions. Zantac first entered the market in the United States in 1986 and continued to be widely used in both prescription and over-the-counter form up until last year, when most versions of the drug were removed from the market due to concerns about the potential risk of cancer from NDMA exposure.

What is NDMA?

“N-Nitrosodimethylamine (NDMA) is a potent carcinogen,” Cynthia Minkley’s lawsuit states. “It used to be a chemical [byproduct] of making rocket fuel in the early 1900s but, today, its only use is to induce tumors in animals as part of laboratory experiments. Its only function is to cause cancer. It has no business being in a human body.” NDMA is the same carcinogenic chemical that has been detected in several other popular medications, including the blood pressure drugs valsartan, losartan and irbesartan, the heartburn drug nizatidine, which is chemically similar to ranitidine, and the diabetes drug metformin. According to the U.S. Food and Drug Administration (FDA), “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.”

In her product liability lawsuit, Minkley names as defendants Boehringer Ingelheim, Sanofi, Pfizer and GlaxoSmithKline, alleging that the drug makers knew or should have known that Zantac exposes users to potentially dangerous levels of a cancer-causing agent, yet failed to disclose the potential risk of cancer to consumers, healthcare providers or federal regulators. It wasn’t until an independent pharmacy known as Valisure notified the FDA last year that it had detected “extremely high levels” of NDMA in ranitidine drug products that the public was notified about the potential for Zantac to cause cancer.

Valisure Submits Citizen Petition on Ranitidine to FDA

In response to the potential risk of NDMA exposure from ranitidine, the FDA has advised drug companies to recall their ranitidine products if testing shows levels of NDMA above the acceptable daily intake limit of 96 nanograms per day. When Valisure first reported finding the human carcinogen NDMA in “every lot tested, across multiple manufacturers and dosage forms of the drug ranitidine,” the pharmacy reported levels of NDMA in excess of 3,000,000 ng per tablet. In September 2019, upon submitting a citizen petition to the FDA calling for the agency to recall all ranitidine-based products, Valisure indicated that the NDMA in Zantac was “likely due to an inherent instability of the ranitidine molecule,” which contains both a nitrite and a dimethylamine, a combination the pharmacy notes is well known to form NDMA. Nearly every version of Zantac and ranitidine have been recalled since September, yet many consumers diagnosed with cancer in recent years remain unaware that their diagnosis may have been caused by NDMA exposure from recalled Zantac pills.

What to Do if You Have been Harmed by Zantac

Minkley’s lawsuit joins dozens of similar Zantac cancer claims filed over the past few months, on behalf of former Zantac users who were diagnosed with stomach cancer, colon cancer, rectal cancer, esophageal cancer and other cancers of the digestive tract. According to allegations raised in the mounting Zantac litigation, consumers were not properly warned about the potential for Zantac to contain NDMA and were therefore unnecessarily exposed to a risk of cancer from exposure to the carcinogen without their knowledge. The plaintiffs in the Zantac litigation argue that, had they been aware of the potential link between Zantac and cancer, they would never have used the medication in the first place. In order to deal with the growing number of Zantac lawsuits being filed through the federal court system, the U.S. Judicial Panel on Multidistrict Litigation will decide later this month whether the claims should be centralized before one judge for coordinated discovery and pretrial proceedings.