FDA Calls for Immediate Removal of All Zantac, Ranitidine Products from the Market

The U.S. Food and Drug Administration (FDA) announced this week that it is asking manufacturers of Zantac and generic ranitidine products to withdraw all prescription and over-the-counter (OTC) versions of the drug from the market immediately. The FDA’s decision is the latest step in an ongoing investigation into the presence of a carcinogenic chemical called N-Nitrosodimethylamine (NDMA) in ranitidine medications, sold under the well-known brand name Zantac. If you or someone you love has been diagnosed with bladder cancer, stomach cancer, pancreatic cancer or another type of cancer that you believe to be related to the use of Zantac or generic ranitidine, contact our consumer advocates at Consumer Justice Foundation as soon as possible to find out how we can help you pursue the compensation you deserve.

What is Zantac?

Since its introduction in the early 1980s, Zantac (ranitidine) has become one of the best-selling medications in the United States, used by millions of people to prevent and treat heartburn, acid reflux, gastroesophageal reflux disease (GERD) and other conditions in which acid backs up from the stomach into the esophagus. Zantac belongs to a class of drugs known as histamine-2 (H2) blockers, which work by blocking the chemical in the body that activates the pumps in the stomach responsible for producing acid. By doing so, Zantac can reduce the amount of acid in the stomach and relieve or prevent heartburn and other acid-related conditions.

What are the Risks of Zantac?

As part of an ongoing investigation into the presence of the carcinogen NDMA in Zantac, the FDA has been regularly testing ranitidine products from multiple manufacturers, in order to evaluate the potential impact on patients who have been taking the heartburn drug. The agency has also asked manufacturers of ranitidine-based drugs to conduct their own testing to assess levels of NDMA in their products. Over the past several months, nearly every version of Zantac and ranitidine have been voluntarily recalled by their manufacturers due to concerns about carcinogenic impurities. According to the FDA’s latest Zantac news release, issued on April 1, federal regulators have determined that “the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity.” As a result of the FDA’s immediate market withdrawal request, ranitidine-based drug products, including Zantac, will no longer be available for new or existing prescriptions or OTC use in the United States.

What You Should Know About NDMA in Zantac

NDMA is classified as a probable human carcinogen, meaning exposure to the chemical may cause cancer in humans. While consumers may be exposed to low levels of NDMA in certain foods and in water without facing an increased risk of cancer, the FDA warns that “sustained higher levels of exposure may increase the risk of cancer in humans.” The FDA was initially alerted to the presence of NDMA in Zantac and ranitidine last summer, when an independent laboratory called Valisure notified the agency that samples of ranitidine tested positive for NDMA. In September 2019, the FDA issued a statement alerting consumers and healthcare providers that some ranitidine medications, including Zantac, may contain NDMA at low levels. At that time, the agency advised users to consider alternative OTC and prescription drug treatments.

Since September, the FDA has conducted additional testing and confirmed that NDMA levels in ranitidine drug products increase even under normal storage conditions. Additionally, the agency warns that “NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers.” Testing also showed that the older the ranitidine drug is, or the longer it has been since the drug was manufactured, the greater the level of NDMA. Based on these findings, the FDA is sending letters to all manufacturers of ranitidine and Zantac drugs, requesting the immediate removal of their products from the market. The agency is also advising consumers taking OTC ranitidine to stop taking the pills, dispose of them properly and not buy any more. Patients taking prescription ranitidine are advised to discuss alternative treatment options with their healthcare providers.

Carcinogenic Chemicals in Popular Pharmaceutical Drugs

In addition to ranitidine (Zantac), the carcinogenic chemical NDMA and others, like N-Nitrosodiethylamine (NDEA) and Nitrosomethyl-N-butylamine (NMBA), have been unexpectedly found in several popular pharmaceutical drugs, including the blood pressure medications valsartan (Diovan), losartan (Cozaar), irbesartan (Avapro), olmesartan (Benicar), eprosartan (Teveten), candesartan (Atacand) and telmisartan (Micardis). The FDA also recently warned consumers about the presence of NDMA in the antacid drug nizatidine, which is chemically similar to ranitidine.

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