NDMA Problems with Zantac May be Linked to Storage Temperature, Oxygen Levels and Humidity

Ongoing scientific research has sought to learn more about the potential for recalled Zantac to cause cancer in users due to exposure to the carcinogen N-nitrosodimethylamine (NDMA). In one new study published earlier this month in the journal Chemical and Pharmaceutical Bulletin, researchers from the National Institute of Health Sciences in Japan found that environmental factors such as oxygen levels and moisture, as well storage temperature, may play a role in the potential for Zantac’s active ingredient to convert to NDMA. Thousands of Zantac lawsuits have been brought against the makers of Zantac and ranitidine by consumers who developed bladder cancer, kidney cancer, pancreatic cancer and other cancers. If you or someone close to you was diagnosed with cancer allegedly caused by Zantac, contact us as soon as possible to find out if you are eligible to file a Zantac claim.

Before it was recalled earlier this year, ranitidine (best known by its brand name Zantac, which was sold by Sanofi) was a best-selling antacid commonly used to treat heartburn, stomach ulcers, acid reflux, acid indigestion and gastroesophageal reflux disease (GERD). The medication belonged to a class of drugs known as histamine-2 (H2) blockers and was available over the counter (OTC) and in prescription form. For decades, Zantac was marketed by Sanofi as a safe and effective heartburn medication without any warnings about the potential for the drug to expose users to N-nitrosodimethylamine (NDMA), which has been classified as a probable human carcinogen.

The presence of NDMA in Zantac tablets was first discovered in June 2019, when the independent pharmacy Valisure found dangerously high levels of NDMA during routine testing of Zantac and its generics, some at levels more than 30,000 times the “safe” limit set by the FDA. Research conducted by Valisure and others found that NDMA contamination in ranitidine drug products was due to the “inherent instability” of the ranitidine molecule, and in September 2019, Valisure petitioned the FDA to issue a nationwide Zantac recall.

Subsequent FDA investigations into the safety of Zantac indicated that NDMA levels may increase in ranitidine even under normal storage conditions and may increase significantly in ranitidine products stored at higher temperatures, and as of April 2020, all versions of Zantac and ranitidine have been recalled in the United States. In this new study, researchers studied the impact of high-temperature storage on the stability of ranitidine (Zantac), specifically regarding the potential formation of NDMA. They found that the amount of NDMA in two different brands of ranitidine tablets substantially increased from 0.19 to 116 ppm and from 2.89 to 18 ppm, respectively, when stored under accelerated conditions (40°C with 75% relative humidity) for up to eight weeks.

“The formation of NDMA that exceeded the acceptable daily intake limit (0.32 ppm) at the temperature used under accelerated storage conditions clearly highlights the risk of NDMA formation in ranitidine formulations when extrapolated to storage under ambient conditions,” the researchers wrote. “Storage of ranitidine tablets and reagent powders at the high temperatures also increased the amount of nitrite, which is considered one of the factors influencing NDMA formation.”

Storage temperature wasn’t the only factor that influenced the formation of NDMA in ranitidine, however. The researchers found that environmental factors such as moisture and oxygen levels were also associated with the formation of NDMA in ranitidine. Based on their findings, the researchers noted the importance of controlling and monitoring drug storage temperatures and other stability-related factors, such as humidity and oxygen levels, as well as controlling impurities during the manufacturing process, in order to reduce the potential nitrosamine-related health risks associated with certain pharmaceutical drugs.

When the FDA requested the immediate removal of all ranitidine products (Zantac) from the market earlier this year, the agency noted that “the [NDMA] impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity.” With the Zantac recall announcement, the FDA advised consumers taking OTC ranitidine to stop taking the medication, dispose of it properly and not buy any more. The agency recommended that patients taking prescription ranitidine speak to their healthcare provider about alternative treatment options. For those consumers who were diagnosed with cancer while using Zantac or after they discontinued treatment, compensation may be available through a Zantac cancer lawsuit.