Sanofi, GSK face DOJ probe over possible fraud involving Zantac, ranitidine cancer risks

Zantac and ranitidine users with cancer may qualify to file a lawsuit.

The manufacturers of Zantac (ranitidine) are facing a Justice Department probe over allegations they failed to disclose the heartburn drug was contaminated with the cancer-causing chemical NDMA. Sanofi and GlaxoSmithKline, the two manufactures of Zantac, also face hundreds of lawsuits filed by patients diagnosed with cancer after using the drug or its generic equivalent, ranitidine.

Zantac and ranitidine were recalled by the Food and Drug Administration in April 2020 after tests showed that these drugs were contaminated with NDMA. Laboratory tests have shown that NDMA is “probably carcinogenic” to humans, especially at higher doses or for prolonged periods, such as the type of exposure that would occur among patients who regularly take Zantac or ranitidine to treat heartburn, acid reflux, gastrointestinal reflux disease (GERD), or other stomach conditions.

In June 2020, both Sanofi and GSK disclosed that they had received civil investigation demands from the Justice Department seeking information about Zantac. DOJ investigators are investigating whether the two drugmakers may have violated the False Claims Act and committed fraud by failing to disclose to the public that Zantac was contaminated with NDMA.

The DOJ’s investigation into whether Sanofi and GSK concealed information about the contamination of Zantac and ranitidine has been bolstered by evidence uncovered in recent lawsuits filed against the two companies. According to a lawsuit recently filed in Louisiana, GSK may have intentionally omitted NDMA from a 1981 study that discussed the byproducts of ranitidine that are secreted by the body.

Other studies published before the FDA’s Zantac recall also indicated that patients who use this drug may be exposed to NDMA. Another study published in 1981 found that NDMA could be produced by the body when patients used Zantac or ranitidine together with nitrates, a type of chemical that is commonly found in food. Several studies published in 1987 also raised concerns about the presence of cancer-causing chemicals in Zantac and ranitidine.

FDA recalls Zantac, ranitidine due to contamination with cancerous chemical

The first recent evidence linking Zantac and ranitidine to an increased cancer risk was uncovered in June 2019. That month, the online pharmacy Valisure uncovered NDMA in samples of Zantac and ranitidine that it tested.

After providing this information to the FDA, the agency launched its own investigation to determine whether Zantac and ranitidine could increase the risk of developing cancer. When FDA tests confirmed that these heartburn drugs were contaminated with NDMA, Sanofi, GSK, and other companies that manufacture Zantac or generic ranitidine began recalling the drug from sales. Over the following months, many national pharmacy chains also began to pull the heartburn drugs from sale.

Following additional tests by the FDA — which confirmed that Zantac and ranitidine were contaminated with NDMA — the agency finally ordered the recall of the two heartburn drugs in April 2020.

Hundreds of lawsuits filed by patients who were diagnosed with cancer after using Zantac or ranitidine have been filed against GSK, Sanofi, or other drugmakers in the months since the first evidence linking these drugs to an increased cancer risk were made public.

Free Consultation for Zantac, Ranitidine Users With Cancer

If you or a loved one used Zantac or ranitidine and have been diagnosed with cancer, you may be eligible to file a lawsuit against the manufacturers of these drugs. The first step in taking legal action is to speak with an experienced pharmaceutical liability attorney, who can explain your legal rights and options, and walk you through the first steps in filing a case.

For more information about filing a Zantac or ranitidine lawsuit — and to find out whether you may be eligible to file a case — contact the lawyers at Hissey, Mulderig & Friend to receive a free legal consultation. You can reach us by calling toll-free at 1-866-806-8117, or by filling out the free case evaluation form located on the right side of this page. After we receive your information, one of our representatives will contact you to ask you some additional questions and schedule your consultation.

About the Author: Hissey, Mulderig & Friend