Zantac has become a household name when it comes to chest “burning” and discomfort after eating.
Gastroesophageal reflux disease—aka heartburn—is no joke, and Zantac has been an accepted go-to for its’ reprieve for decades—used by millions each year with little-to-no concern as to its’ overall safety.
But the medication’s popularity is likely to wane following a recent voluntary recall. French drugmaker Sanofi pulled Zantac from pharmaceutical and grocery store shelves and issued a statement that disclosed their reasoning—the discovery of possible contamination due to a probable cancer-causing agent found in the drug’s chemical makeup.
Zantac (ranitidine) is an over-the-counter heartburn relief drug, manufactured by pharmaceutical company Sanofi. It works to reduce symptoms associated with the gastric-related ailment by decreasing the production of certain stomach acids used to help break down the foods you consume—all a normal and necessary function of digestion. Ranitidine, the active ingredient in Zantac, is also known as an H2 blocker because it acts by binding to proteins in the stomach called histamine H2 receptors. By doing so, it inhibits the release of gastric acid affected by these receptors. These potent acids can cause acid reflux (when gastric acid enters the esophagus) in some people, which then leads to heartburn. Heartburn is a debilitating symptom of gastroesophageal reflux disease rather than a disease on its own. Zantac comes in capsules or tablets and liquid forms, including a syrup and intravenous form. It is also commonly prescribed to treat stomach ulcers.
Another possible serious side effect can now be added to the list for Zantac users’ awareness. U.S. Food and Drug Administration (FDA) testing revealed that low levels of a “probable human carcinogen” (or possible cancer-causing agent) were found in some Zantac products. The contaminant called into question is known as N-nitrosodimethylamine or NDMA for short. Its’ ability to form naturally via certain industrial or chemical processes is likely key to how it appeared in Zantac products. Some research even suggests that NDMA might form during the body’s metabolization of Zantac’s active ingredient ranitidine. After patients took ranitidine, NDMA was readily found in their urine. One risk that should be further evaluated, per the study’s authors, is the possible development of bladder cancer attributable to long-term use of ranitidine.
Several studies suggest that NDMA exposure might lead to cancer. These studies show that NDMA consumption is associated with the development of certain cancers, including gastric and pancreatic cancers. The amount of NDMA exposure associated with cancer development in these studies was high and frequently occurring vis-à-vis the consumption of certain foods. Another study found that NDMA exposure by way of potentially contaminated medication showed no increased risk of developing cancer in the short-term. But researchers concluded that additional studies would need to be carried out to determine long-term effects.
The Food and Drug Administration (FDA) released a statement in September 2019, informing the public that a “nitrosamine impurity” of NDMA was found in Zantac and other ranitidine medicines at low levels. NDMA can also be found in water, smoked foods or cured meats, dairy products, vegetables, cosmetic products, cigarette smoke and certain medications, according to the Environmental Protection Agency (EPA). The FDA noted that the levels of NDMA found in Zantac in preliminary tests barely exceeded amounts found in common foods. The federal entity concluded that while “NDMA may cause harm in large amounts,” patients should trust that their medicines are safe and that the benefits of taking them outweighs the risks. But the agency also pointed out that the investigation was ongoing. Just approximately one month later in mid-October 2019, Sanofi enacted its voluntary recall of Zantac over-the-counter medications in the U.S. and Canada “as a precautionary measure. Sanofi wrote, “Evaluations are ongoing on both drug substance (active ingredient) and finished drug product. Due to inconsistencies in preliminary test results of the active ingredient used in the U.S. and Canadian products, Sanofi has made the decision to conduct the voluntary recall in the U.S. and Canada as the investigation continues.” The FDA previously warned about NDMA in certain blood pressure medicines in 2018.
People using Zantac OTC are encouraged to speak with their doctor about discontinuing use of the medication and discussing other treatment options. Additionally, if you were prescribed Zantac and you believe you may have suffered injury or illness as a result of taking the medication, you need to speak with an experienced drug injury attorney. You and your family may be awarded monetary damages to help cover costly treatment, as well as replace lost wages and compensate you for your past and ongoing pain and suffering. Contact us today at 1-800-256-7728 or here on our website for a free case evaluation.