DOJ investigates Zantac drugmakers after failed disclosure of possible carcinogen

The Carlson Law Firm is no longer handling Zantac Claims. Please visit your state’s Bar website to find an attorney who may be able to assist. 

This information is for archival purposes.

The U.S. Department of Justice is investigating drugmakers Sanofi and GlaxoSmithKline. The investigation will center on the drug makers’ awareness of Zantac‘s cancer risk and when they may have known that the main ingredient was contaminated with carcinogenic byproduct N-nitrosodimethylamine (NDMA). 

Zantac generated billions of dollars in sales being marketed as a safe and effective treatment for heartburn. However, it was discovered late in 2019 by an independent pharmacy that the pill contained high levels of NDMA. This discovery prompted a recall for most of the versions of ranitidine medications.

Further, disclosed filings revealed that the drugmakers received so-called civil investigative demands in June for information that indicated potential violations of the False Claims Act, suggesting that Sanofi and GlaxoSmithKline submitted false claims to the government agencies for reimbursement.

What Cancers are associated with Zantac?

NDMA is a chemical byproduct of rocket fuel and can be found in softeners and lubricants. It is classified as an animal carcinogen and probable human carcinogen.  

• Liver Cancer
• Bladder Cancer
• Breast Cancer
• Intestinal Cancer
• Colorectal Cancer
• Pancreatic Cancer
• Esophageal/Nasal/Throat Cancer
• Kidney Cancer
• Lung Cancer
• Prostate Cancer

How was the Zantac NDMA contamination found?

Independent online pharmacy Valisure found that some 150 mg Zantac pills contained more than 3 million nanograms of NDMA. This far exceeds the FDA guideline maximum daily exposure limit of only 96 nanograms. 

Valisure tests drugs thoroughly before sending them to customers. In September 2019, the company filed a citizen’s petition to the FDA that asked for Zantac to recall after detecting high levels of N-Nitrosodimethylamine in every Zantac batch tested. 

NDMA has also been found in blood pressure medications

In addition, dozens of blood pressure medications have been recalled after discovering potential cancer-causing impurities in them. Beginning of Summer 2018, the FDA learned and reported that Valsartan contained nitrosamine impurities, including N-Nitrosodimethylamine (NDMA). Many types of Valsartan were recalled, the latest being American Health Packaging’s 160 mg tablets. Other common prescription drugs that recalled include losartan and irbesartan in different combinations from different manufacturers. In each case, the recalled drugs were contaminated with N-Nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA), or N-Nitroso N-Methyl 4-amino butyric acid (NMBA). These chemicals are believed to cause cancer in humans. Research suggests that NDEA can cause blood and liver cell damage. 

The Carlson Law Firm Can Help

The Carlson Law Firm is handling Zantac lawsuits. If you or a loved one suffered injuries from the NDMA-contaminated Zantac, please contact our law office to speak to one of our attorneys. We will ensure that your Zantac lawsuit will get you a favorable recovery.