Zantac Was Once The World’s Most Popular Drug, But Lawsuit Claims It Was Never Safe

According to allegations raised in a recently filed class action lawsuit, exposure to Zantac always resulted in the development of carcinogenic impurities that may increase the risk of cancer for users, yet the drug makers withheld information from consumers and the medical community.

A complaint (PDF) filed by Lynn White and Nataliya Birman in the U.S. District Court for the Northern District of Illinois, indicates that Zantac was never safe for consumers, even though it has been one of the most popular brand-name medications on the market in the U.S. for decades.

White indicates that she was first prescribed Zantac in 1987, and continued to fill prescription versions of the medication until 2017, when she began using widely available over-the-counter (OTC) versions of the drug. Birman indicates that she took over-the-counter Zantac from January 2019 until April 2019.

Both women say various drug makers who have manufactured and sold the brand-name version never disclosed that ranitidine in Zantac produces high levels of the chemical N-Nitrosodimethylamine (NDMA), which may increase the risk of stomach cancer, bladder cancer, colorectal cancer, kidney cancer and other cancers along the digestive tract.

The lawsuit names GlaxoSmithKline, Sanofi, Sanofi-Aventis, Chattem, Inc., Glenmark Pharmaceuticals and Dr. Reddy’s Laboratories as defendants, indicating that the public was not informed about the potential Zantac cancer risks until earlier this year, when an independent pharmacy confirmed that each pill may result in levels of exposure that are substantially higher than the permissible daily intake limit for NDMA set by the FDA, leading to widespread Zantac recalls throughout the U.S.

While many consumers believe Zantac was recalled due to issues with contamination, the production of NDMA is actually part of the inherent instability of the active pharmaceutical ingredient in the heartburn drug, ranitidine. Both women say they would have never taken the drug if they had been informed of the cancer risks from Zantac, which users have faced since it first hit the market.

Zantac (ranitidine) was first approved as a prescription heartburn drug in 1983. Amid aggressive marketing, it become one of the best-selling drug in history by 1988, and was the first medication to surpass $1 billion in annual sales.

“Zantac’s dominance and staying-power has been attributed to the aggressive and inventive marketing strategy of its developer, GlaxoSmithKline plc, and to the belief by its users, such as Plaintiffs Lynn White and Nataliya Birman, that ranitidine, including Zantac, was completely safe,” the lawsuit notes. “But, as it turns out, ranitidine is not safe. It produces high quantities of Nnitrosodimethylamine (NDMA) in the body, a chemical that according to the World Health Organization is ‘clearly carcinogenic’.”

The lawsuit seeks class action status for all Zantac users, calling for reimbursement for the money they spent on the drug and for the manufacturers and distributors to pay for medical monitoring due to users’ increased risk of cancer.

The case joins a growing number of Zantac lawsuits filed in recent weeks, including claims brought on behalf of individuals diagnosed with stomach cancer, bladder cancer, colorectal cancer, esophageal cancer and other cancers along the digestive tract, alleging that ranitidine contained in Zantac breaks down into NDMA inside the body.

NDMA is a chemical byproduct, which is considered a carcinogen. It used to result from making rocket fuel in the early 1900s, but today is only used in laboratory experiments to induce cancer in animal test subjects.

Last year, a number of generic blood pressure drugs were recalled after it was discovered that NDMA was contaminating valsartan, irbesartan and losartan pills due to changes in the drug manufacturing process. To avoid shortages following the valsartan recalls, the FDA established a permissible limit for NDMA at 96 nanograms per day. However, the levels found in each Zantac tablet are 29,000 times that limit.

In September, the online pharmacy Valisure filed a Citizens Petition with the FDA, calling for all versions of Zantac to be recalled from the market, since NDMA was created due to the inherent structure of the active pharmaceutical ingredient in the heartburn drug, indicating that all users may be exposed to unacceptably high levels of the cancer-causing chemical.

As lawyers continue to investigate potential Zantac cancer claims over the coming months and years, it is widely expected that hundreds, if not thousands, of lawsuits similar to this one may be filed against manufacturers of the drugs.