Zantac Maker Facing Lawsuits Over Carcinogen

Lawsuits have been filed alleging that Sanofi-Aventis, maker of Zantac, failed to warn users that the medicine could produce unsafe levels of a probable carcinogen after being ingested.

Attorneys working with are now investigating whether more lawsuits can be filed on behalf of Zantac users who were diagnosed with cancer. The lawsuits, if successful, could help pay for medical expenses and other damages associated with taking Zantac.

Why Were Lawsuits Filed?

The first lawsuits were filed after online pharmacy Valisure notified the FDA that it had detected “extremely high levels” of a probable carcinogen known as n-nitrosodimethylamine (NDMA) in “every lot tested, across multiple manufacturers” of ranitidine products, including Zantac.

According to Valisure, an “inherent instability” in ranitidine can cause it to react with itself to produce NDMA. Testing performed by the pharmacy detected more than 3 million nanograms of NDMA per tablet, which amounts to more than 31,000 times the FDA’s maximum daily intake limit.

After receiving Valisure’s petition to recall ranitidine products, the FDA announced that its own testing revealed “unacceptable levels” of NDMA in samples of ranitidine.

The lawsuits are arguing that Zantac’s manufacturer, Sanofi, knew Zantac could convert to NDMA in the body, yet failed to warn users about the serious health risks—including cancer—that came with taking the medicine.

Did Zantac Get Recalled?

Yes. On April 1, 2020, the FDA requested that manufacturers immediately recall all prescription and over-the-counter (OTC) ranitidine medications.

According to the FDA, testing has revealed that NDMA levels in ranitidine drugs increase over time “even under normal storage conditions” and especially in warmer temperatures. The testing also showed that the older the product is, the greater the level of NDMA it contained, the agency said.

The FDA recommends that consumers stop taking OTC ranitidine products and dispose of the drugs. The agency also stated that those taking prescription products should speak to their healthcare providers before stopping the medicine.

According to the FDA, ranitidine medication, including Zantac, “should not be available to consumers and patients unless its quality can be assured.”

Are These Class Action Lawsuits?

Although class action lawsuits have been filed over Sanofi’s alleged misrepresentations of Zantac as “safe and effective,” those lawsuits are typically seeking to repay users for the money they spent on the medicine itself—and not any damages associated with developing cancer.