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Zantac is a widely used heartburn medication considered safe enough to be sold over the counter — but it has been found to contain a cancer-causing chemical. This discovery has led to a U.S. Food and Drug Administration (FDA) investigation and subsequent recall of Zantac and generic versions of the drug (ranitidine).
Since reaching the market in 1981, Zantac has been widely used to treat conditions such as acid reflux, heartburn, and ulcers. The drug is frequently prescribed by healthcare providers but is also available as an over-the-counter medication. A longtime best selling heartburn medication, it posted sales of $136 million in 2019.
A study performed by online pharmacy Valisure in September of 2019 found that Zantac and its generic equivalent, ranitidine, were tainted with an unsafe level of the cancer-causing chemical NDMA. This finding led the FDA to alert patients and healthcare professionals in 2019. In addition, the FDA encouraged drug manufacturers to test their products and voluntarily recall any products with NDMA levels above the acceptable daily intake (ADI). After conducting their investigation, the FDA requested the makers of Zantac and ranitidine recall all products containing the active ingredient in April 2020.
Zantac (ranitidine)
Manufacturer: Sanofi
Did you take the brand-name Zantac (ranitidine) for one year or more and suffered one or more of the following side effects/injuries?
One initial study on the link between ranitidine and NDMA exposure was criticized for the testing methods used to measure the amount of NDMA present. However, many subsequent studies with different testing methods have confirmed the original study’s results.
NDMA is a nitrosamine, a chemical found in small amounts in drinking water and some foods like smoked meats. Exposure to these amounts is not believed to be harmful. Unfortunately, research shows that the amounts in ranitidine-containing medications are far higher and above what’s considered a safe limit for human exposure.
With many drug recalls, it is found that contamination occurs from an outside source, often found at a factory where the drug is produced. In most of these situations, only some batches of the medication are affected. The problem can be eliminated, the affected lots recalled, and the factory can return to production.
Unfortunately, in the case of ranitidine, this isn’t a possibility. Researchers learned that NDMA is not an impurity that is accidentally added to ranitidine but a byproduct of the drug itself breaking down. The ranitidine molecule was found to be inherently unstable, and over time, it breaks down, producing NDMA. For this reason, older packages of the drug likely contain more NDMA than newer ones. Also, heat causes the medication to break down faster, so packages left in a hot delivery truck or a hot car could also have higher levels.
Several studies have found at least a two-fold increase in the risk of stomach/esophageal cancer in people who took prescription ranitidine versus those who didn’t. There were also positive associations between ranitidine use and liver cancer, pancreatic cancer, and colorectal cancer.
Unfortunately, it’s difficult to calculate an individual’s risk of cancer based on ranitidine use because the levels of NDMA vary based on the age and storage conditions of the drug. There is no way to know how long a box of medication you took in 2019 sat on a shelf before you bought it or if it was ever stored in high-heat conditions. The best thing you can do to protect your health is to see your doctor for regular health screenings, especially if you develop any new symptoms.
If this has happened to you or a loved one, you may be entitled to compensation from the makers of Zantac and generic ranitidine. You may be able to seek damages for your medical bills, lost income, pain and suffering, permanent disability, and if you have lost a family member to cancer, wrongful death. Please contact an experienced dangerous drugs lawyer immediately, as you may have limited time to file a lawsuit.
We are deeply troubled that a drug trusted by millions of patients was tainted and could cause cancer. If you or a family member believe you are suffering from severe complications and side effects associated with Zantac, first see a physician. Then contact our experienced attorneys at Goldblat + Singer, the St. Louis Injury Law Firm, at 314-888-1000 to arrange a free, no-obligation, and completely confidential consultation. We are prepared to file lawsuits on your behalf.