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In October 2019, several big-box retailers stopped selling Zantac and other medications with ranitidine. The drug Zantac and its active ingredient, ranitidine, belong to a group of drugs called histamine-2 blockers and are commonly used to treat and relieve the effects of heartburn by reducing the amount of acid your stomach makes. The recall of these drugs by drug companies began with results that show the presence of NDMA (Nitrosodimethylamine), a dangerous carcinogen, in medications with ranitidine as an ingredient. The research presents findings that ranitidine is unstable and can form the carcinogen NDMA when ingested. While not all ranitidine medicines marketed in the US have been recalled, the FDA has instructed companies to recall their ranitidine medications if they test above the acceptable daily intake limit for NDMA.
What is NDMA?
NDMA stands for N-nitrosodimethylamine and is a type of nitrosamine compound classified as a probable carcinogen in humans by the International Agency for Research on Cancer. It’s found in smoked and cured meat products, cigarette smoke, toiletries and cosmetics. The consumption of NDMA is positively correlated with gastric and colorectal cancer.
A company called Valisure performed independent chemical analyses on a variety of drugs and brands based on Good Manufacturing Practice regulations from the FDA. These regulations are in place to determine if ingredients and materials have been contaminated or made impure. Valisure began testing ranitidine for NDMA after the carcinogen was found in the blood pressure drug called Valsartan. Because an infant daughter of the company’s cofounder was taking ranitidine it was one of the first drugs tested for the carcinogen. Valisure used a high-heat test and found 3mg of NDMA in a single 150mg ranitidine pill. Not good at all. After multiple retests with lower temperatures, high amounts of NDMA above FDA-accepted levels were still found in the tablets. The acceptable daily intake of NDMA is only 96 nanograms.
Why File a Zantac Lawsuit?
While Zantac is used to treat heartburn and acid reflux-like symptoms, it is a commonly purchased over-the-counter medicine that comes with an increased risk of several types of cancer. Research shows that NDMA present after consumption is the result of the “inherent instability” of the ranitidine molecule. Recent lawsuits allege that the manufacturer Sanofi did not warn users about the instability of the main ingredient or that it creates a carcinogen once ingested. Lawsuits are being filed across the country against Sanofi U.S. Services Inc. for products liability, negligence and fraud.
NDMA exposure from Zantac may be linked to:
Have you or a loved one been diagnosed with any of the above forms of cancer and have used Zantac regularly in the past? If you are using Zantac at the moment or have used it in the past and developed cancer, you may be able to file a lawsuit against Sanofi. You may be entitled to financial compensation in the settlement to pay for treatment, lost wages, pain and suffering and other costs. Be sure to discuss your next steps with your doctor to find a suitable replacement for ranitidine and call the attorneys at Lewis & Feldman, LLC to begin consultation on your case.