Drug manufacturers Sanofi-Aventis and Boehringer Ingelheim Pharmaceuticals are facing a class-action lawsuit related to the popular heartburn remedy Zantac. According to the claim, filed in the northern district of California, a known carcinogenic compound called N-nitrosodimethylamine (NDMA) has been detected in ranitidine, the active ingredient in Zantac.
Zantac is an over-the-counter medication that treats heartburn by reducing stomach acid production. It also treats other conditions, such as ulcers of the stomach and intestines, throat issues such as erosive esophagitis, the gastroesophageal reflux disease-GERD, and Zollinger-Ellison syndrome, a disease of the gastrointestinal system that results in the production of excess stomach acid. Patients who take Zantac for heartburn may take the medication sparingly as episodes of heartburn arise or may take it over a longer period of time for chronic heartburn. The plaintiffs in the class claim that they all used the drug to treat various conditions for multiple years on end.
According to the Environmental Protection Agency, NDMA is a semivolatile organic chemical that forms in both industrial and natural processes. It is classified as a B2 carcinogen (probable human carcinogen) based on the induction of tumors in both rodent and non-rodent mammals exposed to NDMA by various routes. Potential symptoms of overexposure to NDMA include headache, fever, nausea, jaundice, vomiting, abdominal cramps, enlarged liver, reduced functioning of the liver, kidney, and lungs, and dizziness. The chemical compound is listed as a priority toxic pollutant in the Code of Federal Regulations.
NDMA is found in some blood pressure medicine along with over-the-counter heartburn drugs. According to the Zantac class action, the pharmaceutical companies did not disclose to consumers the high levels of NDMA, despite scientific studies that warn of the dangers. The acceptable threshold of daily NDMA intake, set by the US Food and Drug Administration, is below 100 nanograms. However, a study cited in the complaint against Sanofi and Boehringer states that one 150 milligram pill of Zantac has over 2.5 million nanograms of NDMA. The recommended dosage to treat peptic ulcer disease in adults is two of these 150-milligram pills (300 mg once nightly) for a duration of four to eight weeks, according to the National Institutes of Health's drug record on ranitidine.
The class-action suit claims that the failure to disclose the quantities of NDMA constituted a violation of 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.