Plaintiffs have already begun filing Zantac lawsuits in courts across the country, just day’s after the U.S. Food & Drug Administration (FDA) warned that prescription and over-the-counter versions of Zantac could be contaminated with a cancer-causing impurity.
Millions of people rely on Zantac (ranitidine) to treat heartburn, GERD, peptic ulcers, and other acid-related digestive disorders. Boehringer Ingelheim Pharmaceuticals marketed name-brand Zantac in the United States from October 2006 through January 2017. Sanofi-Aventis has held the rights since then, while numerous generic drug makers market their own versions of ranitidine.
Last Friday, the FDA warned that trace amounts of N-nitrosodimethylamine (NDMA) had been detected in some Zantac samples. The discovery was made by the online pharmacy Valisure, which said it found the chemical in every sample of Zantac or rantidine it tested.
Last year, NDMA was found in the active pharmaceutical ingredient used to make generic versions of valsartan and other angiotensin II receptor blockers, setting off drug recalls around the world.
The U.S. Environmental Protection Agency classifies NDMA as a probable human carcinogen, and animal studies have linked the chemical to various cancers. Research also suggests exposure to NDMA may result in non-cancerous liver damage or internal bleeding and death.
Shortly after the FDA’s announcement, one of the first Zantac lawsuits was filed in South Florida by a single mom diagnosed with breast cancer in 2012. A second case claims the contaminated medication caused a prominent Florida rabbi to develop male breast cancer.
According to her complaint, Nancy Lopez began using Zantac at the age of 15 and believes more must be done to alert the public to its risks.
“This is not about money. This is about saving people,” she told CBS 6 in Miami. “If I can save one, everything is gonna be worth it for me. It doesn’t matter what I’ve been through. That’s not a problem. I just don’t want other people to go through what I went through.”
According to Court House News, a recent California class action lawsuit also claims Sanofi-Aventis and Boehringer Ingelheim Pharmaceuticals failed to warn consumers about the high levels of NDMA in Zantac, despite scientific studies detailing the dangers.
The FDA has set an acceptable threshold of daily NDMA intake below 100 nanograms. However, according to a study cited by the plaintiffs, a single 150 mg Zantac pill could contain as much as 2.5 million nanograms. Meanwhile, the recommended dosage for adults with peptic ulcer disease is 300 mgs once nightly for 4 to 8 weeks.
“Despite the undeniable scientific evidence linking ranitidine to the production of high levels of NDMA, defendants did not disclose this link to consumers on Zantac’s label or through any other means,” the complaint states.