Concern about the link between taking the popular heartburn medication Zantac and cancer has been growing by the day, as manufacturers are recalling their products and retailers are pulling the over the counter medication from shelves. The U.S. Food and Drug Administration (FDA) has confused consumers by saying they do not need to stop taking Zantac and said that the cancer-causing chemical N-nitrosodimethylamine (NDMA) was simply an impurity.
On September 13, 2019, the FDA issued a statement alerting consumers that a cancer-causing chemical called NDMA, was found in low levels in the heartburn medication Zantac, also sold under the generic name ranitidine. This statement specifically said, “The FDA is not calling for individuals to stop taking ranitidine at this time,” but then said, “[p]eople taking over the counter ranitidine could consider using other over the counter (“OTC”) medicines approved for their condition. There are multiple drugs on the market that are approved for the same or similar uses as ranitidine.”
At the time, Zantac maker Sanofi said in a statement that the company “takes patient safety seriously, and we are committed to working with the FDA.”
In an October 2, 2019, statement, the FDA asked manufacturers of ranitidine to send in samples for testing. In their update, the agency said that higher temperatures used in the manufacturing of ranitidine (Zantac) had generated high levels of NDMA and, therefore, was a concern.
As of January 2020, the FDA has advised companies to recall ranitidine (Zantac) if manufacturer testing shows levels of NDMA above the acceptable daily intake (96 nanograms per day or 0.32 parts per million for ranitidine).
It is worth noting that numerous other agencies outside the U.S. cautioned consumers against taking Zantac. At GBM Law, we believe the NDMA chemical was not simply an impurity, but a defect that the makers of Zantac and OTC generics knew or should have known about.
What is Zantac?
Zantac, chemically known as ranitidine hydrochloride, works to decrease the production of stomach acid and is used to treat common acid reflux, heartburn, and gastrointestinal issues, such as gastroesophageal reflux disease, peptic ulcer disease, and Zollinger–Ellison syndrome (Z-E syndrome). It’s been available in the U.S. since the early 1980s. Available dosages vary between 75 and 150 mg. A once-daily Zantac 300 mg dosage is also available.
What is NDMA?
The FDA has said NDMA is a “known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.” NDMA used to be an industrial chemical that was once added to rocket fuel and is a yellow liquid that dissolves in water. It forms during some industrial processes such as tire making and pesticide and dye manufacturing. It is also found in secondhand smoke. It’s been found in levels at over 3,000 times greater than acceptable levels in Zantac.
According to the FDA, consuming as much as one microgram a day of NDMA is “reasonably safe.” The NDMA chemical has already been found in blood pressure medicines categorized as angiotensin II receptor blockers (sometimes called ARBs or angiotensin II inhibitors).
Dangerous Drug Attorneys Investigating Zantac Cases
The personal injury lawyers at GBM Law are investigating Zantac cancer cases and the link between the heartburn drug and cancer, and the actual levels of NDMA that have been in ranitidine. You may have a Zantac cancer case if you took Zantac for a minimum of 4 months prior to being diagnosed with stomach, bladder, kidney, pancreatic, esophageal, intestinal, liver, uterine, testicular, or colon cancer.
We provide free case evaluations to help you understand your legal rights and options. Contact us at 877-706-6446 to speak to a member of our legal team.