Zantac MDL Established in Southern District of Florida (West Palm Beach) Over Cancer-Causing Impurity NDMA

A panel of federal judges consolidated 126 lawsuits over a cancer-causing impurity in the heartburn medication Zantac before the federal court in West Palm Beach, FL. Plaintiffs in all the actions allege that Zantac—and its active ingredient ranitidine—breaks down to form a carcinogen known as N-Nitrosodimethylamine (NDMA).

NDMA is classified as a probable human carcinogen based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

The Plaintiffs have cancer of the bladder, kidney, colon, and stomach, and they charge that the manufacturers, sellers, and distributors of Zantac and other Ranitidine medications knew or should have known that these medications exposed consumers to NDMA, and that defendants concealed the NDMA-associated dangers posed to consumers.

The defendants include Boehringer Ingelheim Pharmaceuticals, Inc.; GlaxoSmithKline LLC; Pfizer Inc.; Sanofi-Aventis U.S. LLC; Sanofi US Services Inc.; and Chattem, Inc.

US District Judge Robin L. Rosenberg will preside over the new MDL No. 2924. The JPMDL transfer order can be found here.

The Judicial Panel for Multidistrict Litigation ruled that all the cases involve common questions of fact:

  • How Ranitidine forms NDMA.
  • The nature and extent of the health risks posed by NDMA and the NDMA levels at issue.
  • Defendants’ knowledge of the NDMA-associated risks of Ranitidine.
  • The impact of any findings made by the U.S. Food and Drug Administration, which is investigating this issue.

The Food and Drug Administration is investigating why NDMA is turning up in drugs used to control high blood sugar in patients with type 2 diabetes, in prescription antacids like Zantac and in Valsartan and Losartan, which treat high blood pressure and heart failure.

Glenmark Pharmaceutical Inc., USA announced on December 17, 2019, the voluntary recall of all unexpired lots of Ranitidine (Zantac) Tablets, 150 mg and 300 mg, to the consumer level. Zantac provides heartburn relief for acid in the stomach and has been sold in the US for more than 30 years.

Also recalling Ranitidine products are Appco Pharma LLC, Aurobindo Pharma USA, Sanofi, GlaxoSmithKline, Novartis, Dr. Reddy’s Laboratories, Perrigo, Novitium Pharma, and Lannett Company.

Research by supplement company Valisure, titled Valisure Detects NDMA in Ranitidine, “found that NDMA was the result of the; ‘inherent instability’ of the Ranitidine molecule. This means that all manufacturers, brand or generic, and all lots of Ranitidine-containing medications are affected and could generate high levels of NDMA in the human body.”

In a 2016 study on oral intake of Ranitidine, scientists examined urine samples from five female and five male healthy volunteers over 24-hour periods before and after consumption of 150 mg of Ranitidine. Following intake, the urinary NDMA excreted over 24 hours increased 400-fold from 110 to 47,600 ng, while total N-nitrosamines increased by 5-fold.

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