Sanofi-Aventis US LLC and GlaxoSmithKline LLC in a pair of U.S. Securities and Exchange Commission (SEC) filings said that they are facing a probe by the U.S. Department of Justice (DOJ) over allegations that the heartburn drug, Zantac, causes cancer.
Zantac (ranitidine hydrochloride) is an antacid and an H2 (histamine-2) receptor blocker used for treating and preventing ulcers in the duodenum, stomach, and intestines. It is also used for treating erosive esophagitis, heartburn, gastroesophageal reflux disease-GERD, Zollinger-Ellison syndrome. In 1983, Glaxo Holdings Ltd, a company which is a part of GlaxoSmithKline PLC, received approval from the U.S. Food and Drug Administration (FDA) to sell Zantac in the U.S. However, owing to patent expiry in 1987 in the United States, Glaxo had to face stiff competition by the generic alternatives launched immediately by competitors. Since 2017, the OTC version of Zantac was marketed by Sanofi in the United States and Canada. In 2004, Pfizer gained FDA approval to sell the Zantac OTC in the United States.
According to a Q3 report published by GlaxoSmithKline (GSK) for the SEC, the manufacturers received a Civil Investigative Demand (CID) from the DOJ on the 18th of June 2020. The DOJ is investigating the information related to Zantac pursuant to the False Claims Act. The report also indicates that the New Mexico Attorney General filed a lawsuit against multiple defendants, including GSK, over the presence of ranitidine in Zantac and other products. Sanofi, in its filing, said that it was notified about the probe on June 6.
The DOJ will be investigating whether the drug makers knew about the presence of the known carcinogenic chemical byproduct N-nitrosodimethylamine (NDMA) in Zantac and yet failed to adequately inform regulators about the potential risks. It will also look into when the manufacturers discovered that the main ingredient in the recalled heartburn drug causes cancer.
The public was not aware of the high levels of NDMA produced by Zantac until the testing was done by an independent online pharmacy, Valisure, in September 2019. The pharmacy claimed that each pill might result in a level of exposure higher than the limit set by the FDA regarding the intake of NDMA and filed a citizen’s petition with the FDA, calling for a recall.
In April, the FDA requested manufacturers to discontinue all versions of Zantac from the market due to the presence of high levels of NDMA.
Currently, more than 230 Zantac lawsuits are pending in the Southern District of Florida. The lawsuits are consolidated and centralized before U.S. District Judge Robin L in Florida under MDL No: 2924, for coordinated discovery and pretrial proceedings.