A Georgia man has filed a federal lawsuit against pharmaceutical companies Sanofi-Aventis US LLC and Boehringer Ingelheim Pharmaceuticals Inc., alleging that his stage 3 colon cancer is a result of taking the heartburn drug Zantac, according to Law360. The plaintiff claims that he developed cancer from Zantac due to the presence of a known carcinogen, N-nitrosodimethylamine (NDMA), in the drug.

It’s not the first suit by a patient saying they’ve developed cancer from Zantac. According to Law360, two other similar cases have been brought against Sanofi since the U.S. Food and Drug Administration (FDA) published a warning about low levels of NDMA found in Zantac. In September, a Florida man with breast cancer sued the company, followed by a Colorado man with bladder cancer in October. 

Can You Get Cancer from Zantac?

Zantac is the brand name of the generic drug ranitidine. According to Healthline, Zantac is used to treat conditions that cause the stomach to produce excess acid as well as intestinal and stomach ulcers and gastroesophageal reflux disease (GERD). Before its recall, it was available as both a prescription or over-the-counter. According to the Sanofi lawsuit, this drug is commonly used to treat adults as well as children and teenagers.

Ranitidine has consistently been linked with the known carcinogen NDMA. According to the suit, the Agency for Toxic Substances and Disease Registry found that “high level short-term and low-level long-term exposures” to NDMA cause liver damage, cancer, and internal bleeding and death in animals.

FDA Zantac Recommendations

On April 1, the FDA published a release calling for the removal of all ranitidine products such as Zantac from the market. It was the latest step in an ongoing investigation into NDMA and its presence in ranitidine medications. The FDA recall means the drug will no longer be available for prescription or over-the-counter use in the U.S.

“The FDA is committed to ensuring that the medicines Americans take are safe and effective,” said Janet Woodcock M.D., director of the FDA’s Center for Drug Evaluation and Research. “We make every effort to investigate potential health risks and provide our recommendations to the public based on the best available science. We decided that [Zantac] should not be available to consumers and patients unless its quality can be assured. The FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits.”

Sanofi Faces Cancer from Zantac Lawsuit

In his suit, plaintiff Robert P. alleges that he developed colon cancer as a result of taking Zantac for several years. His suit claims that manufacturers Sanofi and Boehringer knew or should have known about the presence of NDMA in their drug as well as the health risks associated with it. The suit states that the defendants failed to warn consumers about the risks of developing cancer from Zantac and also alleges that Zantac’s popularity was largely due to false advertising stating that the drug was safe to take. 

Recent testing has revealed “extremely high levels of NDMA in all lots [or rantidine] tested,” according to the lawsuit. These tests showed levels of NDMA in each Zantac tablet more than 26,000 times greater than the amount the FDA says a person can safely ingest each day. According to the suit, NDMA has been categorized as “clearly carcinogenic” by the World Health Organization.

The Cancer From Zantac Lawsuit is Case No. 1:20-mi-99999-UNA filed in the U.S. District Court of the Northern District of Georgia.