Plaintiffs from Connecticut and Florida have filed a class action lawsuit against two drug companies over Zantac and cancer concerns.

Defendants Sanofi U.S. and Boehringer Ingelheim are accused of concealing information about Zantac contamination, which has put patients at risk for developing malignant tumors due to an industrial chemical that has been found in the formulation.

About Zantac

Zantac (generic: ranitidine hydrochoride) is an antacid of the H2 receptor antogonist class. It is used to treat ulcers, acid reflux disease and a cancer-related gastrointestinal condition known as Zollinger-Ellison syndrome. Available in prescription and over-the-counter versions, Zantac may be administered orally or via injection.

Zantac entered the U.S. market in 1981 and within six years, it was the most popular prescription medication in the world. Approximately 15 million prescriptions are written and dispensed in the U.S. every year.

Zantac and Cancer

In September 2019, Connecticut-based pharmacy Valisure discovered N-nitrosodimethylamine (NDMA) contamination of as much as 3,000 micrograms per 75 millgram pill. Part of a class of chemical substances known as nitrosamines, NDMA is an industrial byproduct that has been used in the manufacture of aviation fuel, gasoline and some industrial lubricants, and occurs in trace amounts in smoked or cured meats. It has a high degree of hepatotoxicity and is a known carcinogen (NDMA is used to induce cancer in laboratory rats).

As a result of this discovery, all medications containing raniditine have been recalled by manufacturers.

NDMA contamination has also been discovered in angiotension II receptor blockers (ARBs), a commonly prescribed class of blood pressure medications.

Allegations

The current Zantac and cancer class action lawsuit accuses the defendants of withholding information about a serious defect in the drug’s formulation. When the NDMA contamination was first discovered, Valisure scientists ran simulations of how Zantac is metabolized in the body. They found that when ranitidine begins to break down, it interacts with the patient’s own enzymes, resulting in a chemical reaction that produces NDMA. According to the company’s CEO, David Light, these findings indicate that the molecular structure of ranitidine is inherently unstable.

In other words, NDMA may be built in to the drug’s formulation. Additional studies at Stanford University have confirmed Valisure’s findings.

Other Legal Actions

Since the NDMA contamination was first discovered, at least two other individual lawsuits have been filed, the first of which came on the very day the FDA alert was published. A second lawsuit was filed in Florida by a man with breast cancer (extremely rare in males) after having taken ranitidine for nine years.

Plaintiffs all claim that drugmakers failed in their duty to warn consumers and health care providers of the contamination. Currently available evidence indicates that the defendants had every reason to know about the danger; in addition to the studies at Valisure and Stanford, extensive research over the past 10 years has confirmed that chemical interactions between Zantac and water produces NDMA.

The present Zantac and Cancer Class Action Lawsuit is Case No. 3:19-cv-01517-RNC, U.S. District Court for the District of Connecticut.