(CN) – The manufacturers of over-the-counter heartburn medication Zantac are accused of not warning consumers of a side effect that can produce a known carcinogenic within the body, according to a federal class action lawsuit filed in California on Friday.
The U.S. Food and Drug Administration said the risks behind N-nitrosodimethylamine (NDMA) are unknown but the impurity has been found in ranitidine, the active ingredient in Zantac.
NDMA is found in some blood pressure medicine along with over-the-counter heartburn drugs. According to the 31-page complaint filed in the Northern District of California, the drug manufacturers Sanofi-Aventis and Boehringer Ingelheim Pharmaceuticals did not disclose to consumers the high levels of NDMA, despite scientific studies that warn of the dangers.
The plaintiffs are a group of consumers who say they used the drug to treat various conditions for multiple years on end, while citing studies that found NDMA could cause non-cancerous liver damage or internal bleeding and death.
The FDA has set an acceptable threshold of daily NDMA intake at below 100 nanograms, but a study cited by the plaintiffs says a 150 milligram pill of Zantac has over 2.5 million nanograms. The recommended dosage to treat peptic ulcer disease in adults is 300 milligrams once nightly for 4 to 8 weeks, according to the National Institutes of Health’s drug record on ranitidine.
“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.
Boehringer owned the U.S. rights to Zantac from October 2006 to January 2017 and Sanofi has owned the rights since.
The lawsuit claims the drug manufacturers violated the California Legal Remedies Act for “unfair or deceptive acts” by not disclosing the dangers associated with NDMA and that those business acts constitute violations of the Unfair Competition Law.
Sanofi-Aventis released a statement saying the company takes patient safety seriously and is “committed to working with the FDA.”
“Zantac OTC (over the counter) has been around for over a decade and meets all the specified safety requirements for use in the OTC market,” the statement said.
The plaintiffs are represented by Shana Scarlett of Hagens Berman Sobol Shapiro LLP.