Zantac Recall: What You Need To Know
Zantac lawsuits are being filed after all ranitidine products were removed from the market by the FDA. Click here for more information about filing a Zantac lawsuit.
The FDA requested the removal of all prescription and over-the-counter ranitidine drugs from the U.S. market in April. The recall occurred because high levels of N-Nitrosodimethylamine (NDMA), a probable carcinogen, were found in some ranitidine products.
The FDA advised consumers to stop taking ranitidine drugs and to properly dispose of the drugs instead of taking them to a drug take-back location.
Lawsuits allege that manufacturers of ranitidine products knew or should have known of the possibility of NDMA in ranitidine products, yet did nothing about it and kept selling ranitidine medications.
Dr. Silvio de Flora of the University of Genoa published ranitidine experiment results in 1981. His experiment demonstrated “toxic and mutagenic effects” occurred when ranitidine was exposed to human gastric fluid and nitrates. Dr. de Flora said the effects may have been because of the “formation of more than one nitroso derivative [which includes NDMA] under our experimental conditions.”
GlaxoSmithKline (GSK) responded to these results two weeks later in The Lancet, demonstrating they were aware of the experiment’s results.
Numerous studies showed evidence of carcinogenic nitroso compounds being a problem with ranitidine by 1987. A personal injury complaint alleges that GSK responded with a “rigged” study which determined that human gastric contents of patients who took ranitidine contained no NDMA. The complaint alleges that the study used an inaccurate analytical system and removed all gastric samples containing ranitidine.
“Without the chemical being present in any sample, any degradation into NDMA could not, by design, be observed,” the complaint states.
The complaint alleges that GSK knew or should have known about the inadequacy of that study.
NDMA was known to be a probable carcinogen as far back as 1979, when a news article said that “”NDMA has caused cancer in nearly every laboratory animal tested so far.” NDMA’s only use today is to intentionally give lab animals cancer which scientists can study.
The EPA and International Agency for Research on Cancer classify NDMA as a probable human carcinogen. Data demonstrates NDMA is carcinogenic in a wide variety of animal species, including mice, rats, Syrian gold, Chinese and European hamsters, rabbits, guinea-pigs, mastomys, ducks, various fish, newts and frogs. The World Health Organization says there is “conclusive evidence that NDMA is a potent carcinogen” and there is “clear evidence of carcinogenicity.