January 7, 2020 | Mass Torts
The over-the-counter medication Zantac that’s been recalled across the country may not necessarily have been contaminated with N-nitrosodimethylamine (NDMA), according to online pharmacy Valisure. Instead, they state the source of the probable carcinogen maybe the medication itself, and a breakdown of the ranitidine molecule.
The Connecticut-based pharmacy performs tests on all medications they buy, before shipping them to consumers. Valisure’s tests “detected extremely high levels” of NDMA in every batch of ranitidine they examined, which is Zantac in its generic form. The company’s scientists then notified the American regulators by submitting a petition, requesting a recall and safe destruction of all products containing ranitidine.
That prompted the U.S. Food and Drug Administration to conduct their own testing, but found lower levels of NDMA than Valisure did. However, they were high enough to warrant follow-up testing, which eventually led to voluntary recalls of all ranitidine products that show NDMA levels above the allowable threshold. Contact us for more information about a Zantac lawsuit.
Further testing completed by Valisure’s scientists found that the drug itself could particularly form NDMA in the conditions found in the stomach, as both DMA and nitrite (N) exist in ranitidine. The test mimicking the stomach environment, resulted in a reading of 300,000 ng or 3 milligrams of NDMA from a 150-mg tablet of ranitidine. This amount of NDMA is over 3,000 times more than the permissible intake limit of 96 ng, set by the FDA, which is allowed in angiotensin receptor blockers (ARBs).
David Light, CEO of Valisure, stated that when his company’s testing simulated how the drug breaks down in the stomach, the results suggested one of the body’s enzymes, DDAH-1, might interact with the ranitidine molecule in a way that causes it to unleash the carcinogen.
According to Light, “The fundamental problem is that it’s an unstable molecule. The drug itself can directly degrade and form, with very high efficiency, NDMA.”
Even without the presence of ranitidine, it’s possible for NDMA to form in the stomach during digestion of alkylamine-containing foods. Small amounts have also been detected in breast milk.
The World Health Organization (WHO) has classified NDMA as a probable human carcinogen, or a substance that causes cancer. NDMA exposure in Zantac, or ranitidine, has been linked to cancers such as:
A “probable human carcinogen” means that NDMA is a potent carcinogen in animals, however, there isn’t enough evidence to verify its carcinogen effects on humans. Animals that are exposed to the chemical, have developed tumors in the liver, blood vessels, kidneys and respiratory tract, according to the Environmental Protection Agency (EPA).
Low levels of NDMA can also be found in drinking water, occurring through the degradation of dimethylhydrazine (component of rocket fuel), but are generally harmless. Additionally, the chemical can be found in pesticide manufacturing plants, rubber and tire manufacturing facilities, and tanneries.
The Dunken Law Firm is currently investigating and taking on cases where an individual is suffering from a cancer diagnosis after taking Zantac or ranitidine. Contact our mass tort law firm online for a free consultation or call (713) 554-6780 today.