A popular heartburn drug that causes cancer

The infamous drug Zantac from the British pharmaceutical company GSK, recommended for ulcers and heartburn, was withdrawn from pharmacies around the world in 2019. Experts found an increased content of the toxic substance N-nitrosodimethylamine, which can cause cancer. Thousands of lawsuits from victims who developed cancer after taking the drug for a long time cost the company $5 billion.

Recently, GSK settled the last lawsuit in California, completely closing the expensive litigation. It is noteworthy that in the US and Europe, Zantac and all derivative drugs with the active ingredient ranitidine have been banned and removed from pharmacies. In Ukraine, ranitidine drugs can be bought at any pharmacy. What is the danger of this popular heartburn drug and why did Europe and the United States abandon it?

Zantac: the most popular drug turned out to be carcinogenic?

In 2019, most manufacturers and pharmacies in the world stopped selling Zantac, fearing that its active ingredient ranitidine would degrade over time and form the dangerous chemical NDMA. N-nitrosodimethylamine is a common carcinogen that has a pronounced hepatotoxic effect and can cause cancer.

Although NDMA can be present in food and water, studies have shown that it causes cancer in large quantities.

Taking into account the experts' data, as well as ongoing lawsuits against the manufacturer GSK, in 2020, the FDA withdrew Zantac and its generic versions from the market, which also caused a wave of litigation.

Approved more than four decades ago, Zantac has become the most popular drug in the world. And in 1988, it was one of the first medicines to have annual sales of more than $1 billion. As of October 2023, GSK faced about 79,000 Zantac-related lawsuits in the United States alone.

Storage conditions matter

When the FDA demanded that manufacturers immediately withdraw ranitidine from the market, clinical data on the toxicity of N-nitrosodimethylamine had already appeared. Experts have concluded that the substance can cause cancer and liver and intestinal disorders. For example, studies have shown that less than 1 mg of N-nitrosodimethylamine can cause mutations in mouse cells.

The Agency has found that the amount of impurities in ranitidine preparations increases over time, and when stored at temperatures above room temperature, it can cause toxic effects.

"Although we did not observe unacceptable levels of NDMA in many of the samples we tested, we do not know under what conditions and for how long the product could have been stored. Because of this, we have decided that ranitidine should not be available to consumers and patients because we cannot guarantee its quality," said Janet Woodcock, MD, FDA Commissioner.

The new FDA tests, based on data from several laboratories, confirmed that NDMA levels increase in ranitidine even under normal storage conditions. The substance was found to increase significantly in samples stored at recommended storage temperatures.

Several studies by the agency have also shown that the older the ranitidine product, the higher the level of NDMA in it. This can increase the level of toxicity of the drug.

Given the experts' findings, ranitidine-based drugs have been completely withdrawn from the market in the US and most European countries.

Despite the scandalous reputation of the drug, ranitidine is available in Ukraine at any pharmacy. The drugs are recommended for the complex therapy of gastrointestinal ulcers and heartburn.

Despite the insignificant level of N-nitrosodimethylamine in ranitidine preparations, international experts do not recommend using this product. In case of violation of the temperature and shelf life, production technology, ranitidine can become a dangerous carcinogenic drug that will definitely not benefit your health.