Craig Rosenbaum | January 15, 2020 | Defective Drugs
As of September of 2019, the popular heartburn medicine Zantac (ranitidine) has been recalled and taken off shelves in pharmacies after the Food and Drug Administration announced that it had found the cancer-causing chemical N-nitrosodimethylamine (NDMA) in some batches of Zantac. Major pharmaceutical companies such as Sanofi-Aventis, Chattem, Inc., Boehringer Ingelheim, Pfizer, and GlaxoSmithKline have been listed as defendants in the recently filed lawsuit.
What is Zantac (Ranitidine)?
Zantac is the popular trade name for Ranitidine, a medication that reduces the body’s production of stomach acid. Zantac is available both over-the-counter and by prescription and is one of the most popular drugs available in the United States. Over the counter ranitidine is commonly used to relieve and prevent heartburn. Prescription strengths are also used to treat and prevent more serious ulcers in the stomach and intestines. In 2018, sales of over the counter Zantac were greater than $142 million, a 14% increase over the previous year.
Discovery of NDMA in Zantac
The FDA was made aware on September 13, 2019 that some ranitidine medicines, including Zantac, contained NDMA. NDMA is classified as a probable human carcinogen based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. The EPA classified NDMA as “extremely hazardous,” and there are strict reporting requirements for companies and individuals who produce, store, or use NDMA in large quantities.
It was announced by the FDA on October 2, 2019 that “unacceptable levels of NDMA” were found in samples of ranitidine. According to independent testing by the online pharmacy Valisure, levels of NDMA in one Zantac 150mg tables may exceed 3,000,000 nanograms (ng), which is 26,000 times higher than the FDA’s permissible daily intake for the chemical. The FDA’s permissible daily intake limit for NDMA is 96 ng, but users taking the 150-daily dose of Zantac are exposed to 889,000,000 ng of NDMA over the course of a year. Excessive levels were detected across all brands of Zantac, and Valisure indicated research dating back 20 years has included warning signs about potential problems with the drug.
The Risks Associated with Zantac
Valisure has asserted that when Zantac is broken down in the digestive system NDMA is produced as a result. Valisure’s website posted that their research, “along with that of Stanford University and others, found that NDMA was the result of the ‘inherent instability’ of the ranitidine molecule. This means that all manufactures, brand or generic, and all lots of ranitidine-containing medications are affected could generate high levels of NDMA in the human body.”
In a 2016 study on oral intake of ranitidine, scientists examined urine samples from five healthy female and five healthy male volunteers over 25-hour periods before and after consumption of 150 mg of ranitidine. Following intake, the urinary NDMA excreted over 24 hours increased 400-hold from 110 to 47,000 ng, while total N-nitrosamines increased by 5-fold. “NDMA excretion rates after ranitidine intake equaled or exceeded those observed previously in patients with schistosomiasis,” the researchers wrote, “a disease wherein N-nitrosamines are implicated as the etiological agents for bladder cancer.”
Experts in areas of epidemiology, toxicology and oncology have broken down dietary NDMA studies, occupational exposure studies and animal studies to determine the most likely cancers as the result of exposure to NDMA. Stomach, small intestine, colorectal, esophageal and liver cancers are considered to be the “Tier 1” of most likely cancers, with stomach cancer being the most frequent. Prostate, pancreatic, leukemia, non-Hodgkin’s lymphoma and multiple myeloma are considered to be in the second tier of cancers likely as a result of NDMA exposure.
Current State of Litigation
A group of plaintiffs recently filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate all federally filed Zantac lawsuits into one court for pre-trial proceedings. The plaintiffs assert that all the pending actions involve common factual questions-namely, that plaintiffs purchased ranitidine and were exposed to the carcinogen NDMA. Zantac has been sold in the United States for more than 30 years and the plaintiffs state that “every one of the millions of the drug’s consumers have been exposed to dangerous levels of NDMA and many thousands of those consumers have contracted cancer as a result.” The plaintiffs who filed the initial petition suggest the U.S. District Court for the District of New Jersey as the location for the proposed MDL, mainly because lawsuits involving valsartan contamination with NDMA-which the plaintiffs see as very similar to the lawsuits involving Zantac and NDMA- are consolidated there.