Zantac OTC Lawsuit Claims Heartburn Drug Caused Prostate Cancer

The side effects of over-the-counter Zantac (OTC) caused a New Hampshire man to develop prostate cancer, according to allegations raised in a product liability lawsuit filed after it was discovered the recalled heartburn drug exposed users to high-levels of a carcinogenic chemical byproduct for decades.

William Tsiros filed the complaint (PDF) in the U.S. District Court for the Southern District of Florida on April 15, indicating that manufacturers of the brand-name Zantac OTC failed to provide adequate warnings for consumers and the medical community about the presence of N-Nitrosodimethylamine (NDMA) the heartburn medicine

The lawsuit names Boehringer Ingelheim, Chattem, Inc., Sanofi-Aventis U.S., and Sanofi US Services, Inc. as defendants, indicating Tsiros took their over-the-counter (OTC) versions of Zantac for about seven years before he was diagnosed with prostate cancer in 2017. Tsiros says he would have never taken Zantac had he known about the NDMA cancer risks, which users have allegedly faced since Zantac was first launched in the 1980s.

Zantac (ranitidine) has been a top selling heartburn drug for decades, becoming the first medication to surpass $1 billion in annual sales in 1988, amid aggressive marketing which established it as a safe and effective treatment for acid reflux and heartburn.

According to allegations raised in a growing number of Zantac lawsuits filed in recent months, various manufacturers of Zantac and generic ranitidine have known that the active pharmaceutical ingredient was inherently unstable, and exposure users to dangerously high high levels of the chemical byproduct NDMA, which is toxic and increases the risk of bladder cancer, kidney cancer, colorectal cancer, stomach cancer and other cancers along the digestive tract.

The public was not informed about the Zantac carcinogenic byproduct until September 2019, when an independent pharmacy, Valisure, conducted testing that found each pill may result in levels of exposure that are substantially higher than the permissible daily intake limit for NDMA set by the FDA.

Valisure indicates some 150 mg pills contained more than 3,000,000 nanograms (ng) of NDMA. The daily limit deemed safe by the FDA is 96 ng.

On April 1, after months of removing batches of Zantac as they tested positive for high levels of NDMA, the FDA called for a nationwide Zantac recall, determining that all versions of the heartburn drug pose a risk to the public.

The decision came after the FDA determined that levels of NDMA increase in Zantac over time while it is stored, particularly if it is stored in higher than average temperatures. However, Tsiros’s lawsuit indicates manufacturers knew or should have known about the NDMA problem before the drug was even put on the market.

“At the time that ranitidine was developed, there was already existing scientific literature strongly suggesting that drugs like ranitidine, which contain a dimethylamine (DMA) group, are highly likely to form NDMA, when combined with other substances like, for example, nitrite found in the body,” the lawsuit states. “The dangers of NDMA formation from ranitidine should have been obvious to Defendants.”

As Zantac injury lawyers continue to review and file claims in the coming weeks and months, the size and scope of the litigation is expected to continue to increase, likely involving thousands of complaints filed nationwide.

To deal with the increasing complaints being filed throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation recently ordered all Zantac claims be centralized and consolidated in the U.S. District Court for the Southern District of Florida, where the litigation will be overseen by U.S. District Judge Robin L. Rosenberg during coordinated discovery and pretrial proceedings.