Zantac Bellwether Trials Slated for 2023
Judge Robin L. Rosenberg, who is overseeing the Zantac multidistrict litigation (MDL) in the U.S. District Court Southern District of Florida, outlined dates and procedures for moving ahead with bellwether trials.
Superior Court Judge Sets Dates for First U.S. Zantac Trials
Superior Court Judge Evelio Grillo for the County of Alameda, who oversees the California Ranitidine Product Cases Judicial Council Coordinated Proceedings (JCCP), has set a trial date of October 10, 2022, for the first cancer case trial. Drug makers Sanofi, GlaxoSmithKline, Pfizer, Boehringer Ingelheim, and Chattem will move forward as defendants. Although the JCCP functions similarly to a federal multidistrict litigation (MDL), these cases are adjudicated within the California state court system.
The Zantac-Cancer Connection
On April 1, 2020, the Food and Drug Administration told companies to stop selling Zantac, and they further urged consumers to throw away any form of the heartburn medicine that might be sitting in household medicine cabinets.
Most stores had already taken Zantac, also known as ranitidine, off their shelves last September when the FDA announced that the drug contains a type of carcinogenic nitrosamine (N-nitrosodimethylamine, or NDMA).
FDA Calls for Immediate Removal of Zantac From Market
On April 1, 2020, The U.S. Food and Drug Administration (FDA) announced its request that all Zantac brand heartburn drugs, prescription and over-the-counter, be immediately pulled from the market.
Valisure Finds Unacceptably High Levels of NDMA in Metformin
The small Connecticut-based lab that first sounded the alarm about NDMA contamination in ranitidine (Zantac) is now issuing a similar warning over metformin, a commonly-prescribed, first-line treatment for type-2 diabetes.
NDMA Discovered in a Second Antacid; Manufacturer Issues Recall
Drugmaker Mylan Pharmaceuticals, Inc. has issued a voluntary recall for three lots of the antacid Nizatidine (Axid) after traces of N-Nitrosodimethylamine (NDMA) were discovered in the active ingredient. Although no adverse events have been reported, Mylan is notifying all distributors, retailers, and customers, and has been making arrangements for the return of the affected products.
Is Zantac Turning Into an Industrial Chemical in Your Medicine Cabinet?
Last month, Drug Safety News featured a story about Valisure, a small, independent pharmaceutical testing lab in Connecticut that discovered carcinogenic NDMA in Zantac. It wasn't outside contamination – it was a problem with the molecule at the heart of the formulation.
Major Drugmakers Issue Recalls for Zantac: Was NDMA "Built-In" to the Formula?
With this week's revelations of NDMA contamination in the popular antacid Zantac (ranitidine), health authorities and scientists are asking just how it happened. Frighteningly, there is evidence to suggest that it may have been there all along.