Introduction about Zantac Recall
If you or someone you know takes the medication ranitidine for occasional heartburn or gastroesophageal reflux disease (GERD), you may be aware that the Food and Drug Administration (FDA) has recalled and removed the medication from the market due to concerns of a cancer-causing impurity. However, you may be wondering what that means and what you need to do. We hope this article helps you understand why the recall and what you need to do.
What is ranitidine?
Many people take over the counter (OTC) Ranitidine or commonly known as Zantac to prevent and relieve occasional heartburn. It is also available as a prescription for the treatment and prevention of ulcers as well as the treatment of gastroesophageal reflux disease (GERD).
Ranitidine was available in three strengths; 75mg, 150mg and 300mg. People who have been taking this medication, generally take it once or twice daily. The OTC labeling of this medication indicates a short course of treatment of no more than 14 days for relief or prevention of heartburn. If one requires further relief, one could see their primary care physician for evaluation to determine the root cause of their heartburn.
Ranitidine is classified as a histamine-2 (H2) blocker which works by reducing gastric acid in the stomach. Histamine is a chemical that naturally occurs in one’s body and encourages the stomach to produce acid when one eats to help digest the food. By taking a H2 blocker, one can reduce the amount of histamine produced in turn reducing the amount of acid produced.
Why did the FDA recall ranitidine and then remove it from the market?
In September of 2019, the FDA announced that preliminary tests of ranitidine contained low levels of a probable human carcinogen or a substance that is known to cause cancer. The substance found in these batches of ranitidine was N-nitrosodimethylamine (NDMA). However, at that time, the FDA did not recommend discontinuation but did recommend talking with your doctor about alternatives.
Beginning in October of 2019 through February of 2020, some manufacturers of ranitidine implemented voluntary recalls of their product. It was not until April of 2020 that the FDA requested all ranitidine products be removed from the market. The FDA determined that there were only a few cases unacceptable levels of NDMA found in some samples tested. However, they noticed that the levels of NDMA increase overtime when it is stored at higher than room temperatures. Since there was no way of knowing how old the product was and how it was stored, the FDA decided to remove the product from the market due to a concern for safety. As a result of this request, ranitidine products are no longer available to purchase OTC or prescription.
What is NDMA and what does it cause?
NDMA is an environmental contaminant that is found in water and foods. The substance is unintentionally produced in or released from industrial sources through chemical reactions. NDMA is classified as a carcinogen based on animal studies that showed prolonged exposure to NDMA resulted in tumors. Low levels of NDMA can be ingested from our diets and are not expected to lead to an increased risk of cancer. However, prolonged exposure to higher levels of NDMA could increase the risk for cancers.
What should you do if you take ranitidine?
Since the FDA has formally removed ranitidine from the market, if you, a family member or a friend have been taking this medication the FDA recommends that you discontinue and discuss with your primary healthcare provider about options for further treatment. There are other alternative medications available for the treatment of occasional heartburn in the H2 blocker class as well as other classes. There is no evidence that the other H2 blockers or other heartburn medications have been affected by NDMA impurities.
- Commissioner, Office of the. FDA Requests Removal of All Ranitidine Products (Zantac) from the Market. 1 Apr. 2020, www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market.
- Commissioner, Office of the. “Zantac (Ranitidine): Safety Information – NDMA Found in Samples of Som.” U.S. Food and Drug Administration, FDA, 13 Sept. 2019, www.fda.gov/safety/medical-product-safety-information/zantac-ranitidine-safety-information-ndma-found-samples-some-ranitidine-medicines.