New testing from a California pharmacy has found elevated levels of the probable human carcinogen NDMA in Zantac when the drug is exposed to heat. As a result of its troubling findings, Emery Pharma has filed a Citizen Petition with the Food and Drug Administration (FDA) requesting the agency pull all products containing ranitidine, Zantac’s active ingredient, from the market immediately. The FDA began announcing individual Zantac and ranitidine recalls in September 2019, and the agency announced a universal Zantac recall on April 1, 2020.
Does Heat Produce NDMA?
Emery tested multiple samples of ranitidine stored in different conditions over different periods of time. Samples stored for five days at 158 degrees Fahrenheit were found to contain 142 nanograms of NDMA, well over the FDA’s acceptable limit of 96 nanograms. Equally concerning, samples stored at temperatures as low as 77 degrees Fahrenheit showed a steady increase of NDMA production up to 25 nanograms after 12 days. The latter finding falls under the FDA’s threshold for acceptable levels of NDMA intake, however it raises the possibility that levels could continue to raise over longer periods of time at that temperature.
The results were troubling enough for Emery’s CEO to suggest that even something as simple as leaving the drug in a hot car could lead to NDMA production. “The more you heat it, the more NDMA you generate,” Emery CEO Ron Najafi told Bloomberg News. “I am worried that if it just sits at home at room temperature, it could gradually generate NDMA.”
Why Is This Important?
The most concerning element to Emery’s findings is that NDMA can be produced in ranitidine products after passing through testing done by the manufacturer. Since September 2019, the FDA has been asking pharmaceutical companies to test Zantac and ranitidine products for NDMA contamination prior to putting them on the market. As of April 2020, over 15 different manufacturers and repackaging companies have recalled some or all lots of the Zantac and ranitidine products they produce due to NDMA contamination.
Emery’s findings suggest that Zantac and ranitidine products that have been deemed safe for consumption could still produce enough NDMA to be dangerous if exposed to certain conditions.
Why Is NDMA Dangerous?
According to the World Health Organization, NDMA is a probable human carcinogen, or a substance that causes cancer, that can be found in drinking water in generally harmless levels through the degradation of dimethylhydrazine (component of rocket fuel). NDMA can also be found in tanneries, pesticide manufacturing plants, and rubber and tire manufacturing facilities.
NDMA exposure in Zantac and ranitidine has been linked to cancers such as:
- Bladder Cancer
- Breast Cancer
- Colorectal / Intestinal Cancer
- Esophageal Cancer
- Gastric Cancer
- Kidney Cancer
- Liver Cancer
- Lung Cancer
- Pancreatic Cancer
- Prostate Cancer
Who Is Emery Pharma?
Emery Pharma is an independent laboratory based out of Alameda, California. Emery was hired to conduct these tests by the online pharmacy Valisure, LLC, which had originally petitioned the FDA to recall Zantac and ranitidine products in September 2019. Valisure is an online pharmacy company that launched in 2018 as a pharmacy, lab, and wholesaler. Valisure is licensed in 38 states and regularly analyzes the safety of 2,000 different pharmaceutical products in order to increase individual quality control to the pharmaceutical testing industry.
How Was NDMA Discovered in Zantac?
Once the FDA discovered NDMA and other carcinogens in Angiotensin II Receptor Blocker (ARB) drugs such as Valsartan, Losartan, and Irbesartan, Valisure added more product tests for carcinogens to its testing panels, and one of the first compounds it tested was ranitidine. Valisure’s analysis turned up “extremely concerning results” of 3 milligrams of NDMA, far exceeding the acceptable limits of 96 nanograms per day, in a single 150-mg tablet of ranitidine.
Valisure’s testing found that Zantac is not necessary “contaminated” with NDMA; rather, the carcinogen is produced by the breakdown of the ranitidine molecule during digestion. Valisure CEO David Light explains that “the fundamental problem is that it’s an unstable molecule. The drug itself can directly degrade and form, with very high efficiency, NDMA.” Therefore, Zantac’s NDMA contamination is not specific to a certain manufacturer or batch; it can occur within any ranitidine molecule when exposed to the right conditions.
What Is The FDA Saying?
On April 1, 2020, the FDA recommended the recall of all Zantac and rantidine products from the U.S. market. Previously, the agency had been investigating NDMA contamination of Zantac and ranitidine products since Valisure’s petition in September 2019. Upon analyzing Valisure’s initial findings, the FDA opened an investigation and challenged Valisure’s high-heat testing method that involves heating the compound to 266 degrees Fahrenheit. Instead, the FDA used a lower-heat testing method known as the Liquid Chromatography- High Resolution Mass Spectrometry Method (LC-HRMS) when evaluating ranitidine. Despite using the LC-HRMS, international agencies including the FDA have still found unacceptably high levels of NDMA in ranitidine products.
Countries such as Canada, Germany, France, Italy, Switzerland, and Austria had already recalled ranitidine drugs. In addition, major U.S. drug retailers such as CVS, Walmart, Walgreens, Kroger, and Rite-Aid had removed all ranitidine medications, including name brand Zantac, from their stores.
How We Can Help
GoldenbergLaw is currently investigating cases where an individual has taken Zantac or ranitidine and been diagnosed with one of the digestive cancers listed above. Contact our Minnesota cancer attorneys today for a free consultation or call 612-436-5026. We have over 30 years of experience fighting negligent drug companies and have national leadership in NDMA contamination cases, let us deliver the Gold standard you deserve.