Zantac (Ranitidine) Recalls Remain Recommendation of European Medicines Agency

European regulators indicate recalls for Zantac and all ranitidine-based heartburn medications should remain in place throughout the European Union, due to the presence of a cancer-causing impurity known as N-nitrosodimethyylamine (NDMA).

The European Medicines Agency (EMA) recently issued a press release to announce it has confirmed prior recommendations to suspend ranitidine from the market. The statement came after one of the drug makers selling the generic Zantac requested the EMA re-examine its decision to ban the drug in April 2020.

Zantac (ranitidine) has been a widely used treatment for heartburn and acid reflux for decades, becoming the first medication to surpass $1 billion in annual sales in 1988. However, federal regulators in both the U.S. and the EU have now required Zantac recalls for all versions of the ranitidine-based medication, after discovering ranitidine is inherently unstable and may produce high levels of the cancer-causing chemical byproduct NDMA during storage or inside the human body.

NDMA is a chemical byproduct, which was previously used to manufacture rocket fuel in the early 1990s. However, today, its only use is to cause cancer in animals as part of laboratory experiments.

In the EMA, the re-examination of Zantac safety was conducted by the human medicines committee (CHMP).

“Following the re-examination, the CHMP has maintained the conditions for lifting the suspension of the medicines, including requirements for companies to provide more data on the possible formation of NDMA from ranitidine inside the body,” the EMA stated. “The formation of NDMA in the body is expected to be very low following a single low dose of ranitidine given by injection or infusion (drip). Therefore, the CHMP slightly amended the conditions for lifting the suspension for those ranitidine medicines that are given by injection or infusion as a single, low dose.”

The contamination problems were first discovered by consumers and the medical community in September 2019, when the independent pharmacy Valisure conducted testing which found each pill may result in exposure to levels of NDMA substantially higher than the permissible daily intake limits set by the FDA.

Valisure testing found some 150 mg Zantac pills contained more than 3,000,000 nanograms (ng) of NDMA, even though the safe level set by the FDA is only 96 ng per day.

Thousands of Zantac lawsuits are now being pursued by former users of the medication diagnosed with breast cancer, testicular cancer, kidney cancer, stomach cancer and other health problems following years of exposure to NDMA in Zantac.

Given common questions of fact and law raised in complaints filed throughout the federal court system, the Zantac litigation has been centralized and consolidated in the U.S. District Court for the Southern District of Florida, where the cases are being overseen by U.S. District Judge Robin L. Rosenberg during coordinated discovery and pretrial proceedings.