Zantac: Prescription and Over-the-Counter Drug Found to Contain Carcinogen
Zantac, known generically as ranitidine, a drug prescribed more than 15 million times a year to patients for heartburn worldwide since 1983, was recalled in April by the U.S. Food & Drug Administration (FDA) because of unacceptable levels of a probable carcinogen.
Multiple manufacturers had already issued voluntary recalls of the drug, including Sanofi, the maker of Zantac, as well as generic ranitidine-makers. Major pharmacy chains CVS, Walgreens and Walmart had already suspended sales due to the drug’s link to cancer.
Patients who are taking prescription and over-the-counter versions of ranitidine, a drug widely used to treat stomach acid and ulcers, should stop taking the drug, throw it away and see their doctor for alternative treatments.
The FDA began investigating reports of levels of NDMA, or Ni-nitrosodimethylamine, in the summer of 2019 after an independent lab found high levels of it in ranitidine products and brought it to the attention of the FDA. After initial investigation, the FDA said patients could continue taking the drug and did not face health risks from low levels of NDMA.
NDMA is the same carcinogen that led to a recall in July 2018 of blood-pressure-lowering drugs valsartan and losartan that came from a new manufacturing process first used by a drug ingredient factory in China. Zantac’s risk appears to be the unstable nature of the drug and not manufacturing.
In April, The FDA recalled Zantac completely after determining that contamination poses a greater risk than previously thought because levels of the chemical increase over time, especially if tablets and capsules are stored at higher temperatures, including during distribution and handling by consumers. FDA testing confirmed that NDMA levels increase in ranitidine even under normal storage conditions and that the older a product is, or the longer the length of time since it was manufactured, the greater the level of NDMA.
Studies have shown that the presence of NDMA in ranitidine was known long before the recent discoveries, possibly since the late 1980s. In 2016, Stanford University researchers tested urine samples of 10 people who took 150 milligram Zantac and found NDMA levels far greater than FDA daily limits.
Low levels of NDMA not expected to lead to an increase in the risk of cancer are commonly ingested in the diet, as NDMA is present in food and water. However, sustained higher levels of exposure and exposure for a long time may increase the risk of cancer in humans. According to the Centers for Disease Control (CDC), NDMA has been linked to severe liver disease, liver cancer, testicular cancer and lung cancer.
The FDA encourages health care professionals and patients to report adverse reactions or quality problems with any human drugs to the agency’s MedWatch Adverse Event Reporting Program.
In addition, if you or a family member have taken Zantac or ranitidine and have developed cancer, it could be linked the drug and you may be entitled to compensation from the product’s manufacturer. For a free consultation and more information about your legal options, please call one of our Southwest Florida offices at 239-500-HURT.