Research from the company Valisure — a pharmacy and lab that runs quality tests on medications and drug products — has shown NDMA production can occur while ranitidine is being digested.

The FDA announced in April 2020 that it was asking for an immediate withdrawal of all over-the-counter Zantac and its generic equivalents. That announcement came about seven months after drug company Sandoz Inc. issued the first voluntary recall of the medication on Sept. 23, 2019, when it was connected to an “unexpected impurity, N-Nitrosodimethylamine (NDMA),” which is a probable human carcinogen.

The link between Zantac and cancer has been the subject of several lawsuits. If you or a loved one took Zantac and you were diagnosed with cancer, fill out the form on this page for a free evaluation of your situation by experienced drug injury attorneys.

Sanofi, makers of the brand name Zantac, also issued a recall on Oct. 18, 2019, and several other generic Zantac makers also issued recalls including those that supply Zantac for Walgreens, Walmart, Rite Aid, and CVS.

At the time of the FDA’s announcement, the agency said Zantac was shown to contain trace amounts of NDMA and that levels of the chemical can rise when the product is stored at higher temperatures.

In the study that was published in the Journal of American Medical Research (JAMA) in January, Valisure found that under artificial conditions designed to imitate the human digestive tract, ranitidine was shown to produce dangerous amounts of NDMA.

“Specifically, under simulated gastric conditions, NDMA yield from a standard tablet of ranitidine was seen to increase with both rising nitrite and decreasing pH, to levels up to three orders of magnitude beyond established limits of exposure,” according to Valisure.

And in research for a new study evaluating more than 10,000 cancer patients that was submitted to appear in a new academic paper, Valisure said it found there is a significant association between ranitidine and “elevated diagnosis rates of breast, thyroid, bladder, and prostate cancers.”

The new study’s chemical analysis showed that the rapid formation of NDMA “appears to continue for extended periods of time if the ranitidine remains in gastric conditions.” That is of particular concern, Valisure said, because ranitidine use has been correlated with longer gastric emptying times, meaning food or other ingested material can take longer to empty from the stomach to the small intestine.

The new data “strongly supports decades of research that ranitidine is fundamentally unstable, can form NDMA in a variety of conditions including in the human body, and could be carcinogenic and toxic to humans,” said David Light, founder and CEO of Valisure and an author of both studies. “These findings underscore the vital importance of additional quality assurance testing of on-market drug products.”

Valisure said it previously detailed its concerns about ranitidine in an FDA citizen petition in 2019 – two weeks before Sandroz’s voluntary recall.

“Beyond Valisure’s tests, the presence of NDMA in ranitidine is supported by decades of scientific studies at institutions around the world starting as early as 1982,” Light said. “The data published today adds to a growing body of research that raises serious concern regarding ranitidine and its potential to form the potent carcinogen NDMA.”

One study, from the Fred Hutchinson Cancer Research Center in 2008, connected ranitidine to breast cancer risk, and another from the University of Alabama at Birmingham in 2020 also showed a connection between ranitidine use and gastrointestinal cancers.

Filing a Zantac cancer lawsuit

Hundreds of people have sued the makers of Zantac and generic ranitidine in the aftermath of the voluntary recalls and FDA announcement alleging that the heartburn medication caused cancer.

If you or someone you love have been diagnosed with cancer after using Zantac, you may be able to file a lawsuit and pursue compensation. Filing a lawsuit cannot take away the pain and suffering caused by a cancer diagnosis, nor can it bring a loved one back to life, but it can at least help to alleviate the financial burden incurred by medical expenses, lost wages, and more.

Filing a lawsuit can be a daunting prospect, so Top Class Actions has laid the groundwork for you by connecting you with an experienced attorney. Consulting an attorney can help you determine if you have a claim, navigate the complexities of litigation, and maximize your potential compensation.