January saw a number of new lawsuit filings against manufacturers of Zantac and similar ranitidine-containing medications, alleging that these companies were aware of the danger from NDMA contamination. In fact, although Connecticut pharmaceutical testing lab Valisure was the first to announce the discovery publicly this past September, a Stanford University study published in 2016 showed that ranitidine could produce NDMA in a patient’s stomach.
Ranitidine is an amine-based formulation. Amines are derived from ammonia; such medications react with acids to form a salt that is more water-soluble. The Stanford study noted previous research demonstrating that amines can form NDMA and other nitrosamines when it comes into contact with nitrate at pH levels found in the stomach. In their tests, 10 subjects were given 150 milligrams of ranitidine, after which their urine was tested over a 24-hour period. It was discovered that the amount of NDMA excreted was 400 times the normal level. Researchers also noted that because of metabolic processes in the body, the actual level of NDMA exposure was likely higher.
When Emery Pharma was hired to confirm Valisure scientists’ findings, they discovered that the ranitidine molecule was not only inherently unstable but that it didn’t need to sit in a patient’s stomach in order to transform itself into NDMA. It required only elevated temperatures as might exist in a warehouse or closed automobile on a sunny day.
On January 2nd, the New York Law Journal reported the filing of a class-action lawsuit by a New Jersey woman who took Zantac for 16 years until drug companies began recalls over NDMA fears. According to the complaint, the drug’s manufacturer at the time, Pfizer, “…represented that its Zantac was safe for use,” but contained “dangerously high levels of NDMA, rendering the product dangerous and unfit for human consumption.” Among other allegations, Pfizer stands accused of breach of warranty, unjust enrichment, fraudulent concealment, and violations of state consumer fraud statutes. The plaintiff’s counsel anticipates that the number of class members will be in the five-figure range.