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 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.
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).
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.
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.
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.
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.