GlaxoSmithKline(GSK), the maker of Zantac, a medication commonly used to decrease stomach acid production, was warned by its own scientists and independent researchers about a potential cancer-causing impurity, according to reports by Businessweek. Due to public scrutiny in 2019, when reports were made about high levels of a likely carcinogen, recalls followed and the FDA pulled the drug from the market in 2020. Then the FDA said the amount of the carcinogen, N-Nitrosodimethylamine, increases under normal storage conditions. It gets worse under higher temperatures. According to the Businessweek article, GSK was warned on several occasions about the storage issue but made no changes.
Now there are tens of thousands of lawsuits concerning the drug. The companies involved say that the science does not support the plaintiffs. In 2022 a federal judge dismissed a group of those cases concluding that the experts used unreliable methodologies.
Zantac is an H2 histamine receptor antagonist that works by blocking histamine and thereby decreasing the amount of acid in the stomach. In 2020 it was the 177th most prescribed medication in the U.S. with over 3 million prescriptions. In September 2019, the U.S. FDA learned that some ranitidine medicines, including some products sold under the brand name Zantac, contained a nitrosamine impurity called N-nitrosodimethylamine (NDMA), classified as a probable human carcinogen, at low levels.
The Zantac medication has returned BUT IN A DIFFERENT FORM. Makers have updated the Zantac formula to remove the potentially dangerous ranitidine and replace it with another ingredient called famotidine.
Jeffrey Newman is a whistleblower lawyer who can be reached at 617-823-3217 or at jeff@jeffnewmanlaw.com
