A Colorado man has filed a lawsuit alleging Zantac NDMA levels led to his development of bladder cancer.

Plaintiff Mark B. of Colorado said he began taking Zantac (ranitidine) in 1996, when he started taking the prescription strength version.

Over time, he said he transitioned to taking the over-the-counter strength about four days per week.

Mark alleges that the pharmaceutical companies knew Zantac produced NDMA, a probable human carcinogen, when the human body digested the drug. He is suing Pfizer Inc, Sanofi U.S. Services Inc., Boehringer Ingelheim Pharmaceuticals Inc., Chattem Inc. and Glaxosmithkline Inc., alleging the drug companies knew as far back as 1981 that when Zantac is digested, NDMA is produced.

The lawsuit asserts that the presence of NDMA is not a contamination of the drug but is a side effect of the digestion of the medication itself. According to the Zantac lawsuit, the ranitidine molecule,  contains a nitrite and a dimethylaamine, which when combined, form NDMA.

This is in contrast with the NDMA contamination that was found last year in certain lots of blood pressure medication valsartan, which was found to be caused by a change in the way the drug was manufactured at a factory in China. NDMA can be a byproduct of manufacturing processes.

According to the U.S. Food and Drug Administration (FDA), the maximum allowance of NDMA is 96 nanograms per day based on lifetime exposure. Mark’s ranitidine lawsuit alleges that one Zantac tablet is capable of producing more than 2.5 million nanograms.

The lawsuit notes that Zantac’s sales reached $1 billion in December 1986, a success owed in great part to a successful marketing strategy, which emphasized how allegedly safe the drug was.

In fact, a March 31, 1986 article in the New York Times said that Zantac accounted for 40 percent of Glaxo’s sales and nearly half the drug company’s profits. The article said one of the main reasons the company expected continued growth of Zantac’s profits was because “expected competition from certain new drugs” fell to the wayside “after they were found to produce side effects…”

Concerns of Zantac NDMA Levels

According to BiopharmaDive.com, online pharmacy Valisure reported that its lab found NDMA at levels beyond 300,000 nanograms per tablet of ranitidine. The FDA has questioned the lab’s results, but has also said “unacceptable levels” of NDMA have been found in ranitidine.

The FDA allegedly faulted the lab for using excessive heat that resulted in the production of NDMA from ranitidine. But according to BioPharmaDive.com, Valisure said it was using a body temperature setting, which by itself could not be responsible for the creation of NDMA.

In an email from Valisure to BioPharmaDive.com, Valisure representatives said, “Ranitidine is so unstable that a wide variety of conditions have been shown to degrade it into NDMA by many scientific groups.”

The Zantac NDMA Levels Lawsuit is Case No. 1:19-cv-02991, in the U.S. District Court for the District of Colorado.