FDA Recalls Heartburn Drug Ranitidine: What You Need to Know - NFCR


FDA Recalls Popular Heartburn Drug Ranitidine: What You Need to Know

ranitidine recall

Medication commonly used to treat acid reflux and GERD pulled from the market after scientists find concerning levels of a potential cancer-causing substance in the drug.

In April, the U.S. Food and Drug Administration (FDA) requested that all medications containing ranitidine be pulled from the market after an ongoing investigation uncovered concerning levels of a potential cancer-causing substance known as N-Nitrosodimethylamine (NDMA) in the drug.1 Also known by its brand name Zantac®, ranitidine is commonly used to treat individuals with acid reflux or gastroesophageal reflux disease (GERD).

The recall included all prescription and over-the-counter (OTC) medications containing ranitidine.

The National Foundation for Cancer Research (NFCR) understands that individuals who have taken or are currently taking ranitidine might have questions about this recall. Below, we answer some of the most frequently asked questions about this medication, the recall issued by the FDA, and how individuals can continue to manage their acid reflux or GERD.

What is NDMA?

NDMA is a common environmental contaminant found in water and certain foods. Although it does not cause any harm in small doses, NDMA may cause cancer in individuals who have been exposed to high doses over a long period of time.2

When did the FDA first identify NDMA in medications containing ranitidine?

An independent laboratory first notified the FDA that NDMA had been found in medications containing ranitidine in 2019. This prompted the agency to conduct its own tests, which confirmed the presence of low levels of NDMA in ranitidine. However, there was not enough evidence to recommend whether individuals should continue or stop taking these medications.

Recently, additional tests confirmed that the levels of NDMA in some medications containing ranitidine increase over time, particularly when the medicines are stored at higher than room temperature, resulting in individuals’ exposure to unacceptable levels of this potential cancer-causing substance. These new findings prompted the FDA to formally request that all medications containing ranitidine be pulled from the market in April 2020.1

What should I do if I have taken medications containing ranitidine in the past?

If you or someone you know is currently taking a medication that contains ranitidine, the FDA recommends that you stop taking the medication, properly dispose of it, and not purchase more.1

Due to the ongoing COVID-19 pandemic, the FDA recommends that individuals dispose of their medications at home, instead of taking them to a drug take-back location.1 For information about how to safely dispose of medications containing ranitidine at home, individuals can review the disposal instructions in their medication package insert or follow the FDA’s recommended disposal steps.

Does having acid reflux or GERD increase my risk for developing cancer?

Having acid reflux or GERD is a known risk factor for developing certain cancers, including esophageal and stomach cancer. Although esophageal and stomach cancer are rare, these illnesses can be devastating for patients who are diagnosed. Oftentimes, neither illness causes symptoms in its early stages, with symptoms such as acid reflux or GERD appearing only after the disease has advanced.

Visit the NFCR’s Stomach and Esophageal Cancers webpage for more information about both of these conditions. If you are concerned about your acid reflux or GERD symptoms, or are experiencing other unusual gastrointestinal symptoms that do not go away, please speak with your health care provider.

How can I manage acid reflux or GERD if I can no longer take medications containing ranitidine?

Acid reflux and GERD symptoms can be unpleasant to cope with on a regular basis. In addition to living a healthy lifestyle that includes regular exercise and a nutrient-rich diet, there are many medications available to help alleviate the symptoms associated with acid reflux and GERD. Medications such as famotidine (Pepcid®), cimetidine (Tagamet®), esomeprazole (Nexium®), lansoprazole (Prevacid®), and omeprazole (Prilosec®) are available both by prescription and OTC to help manage these conditions. None of these medications have been found to carry the same risks from NDMA as ranitidine.1 Individuals are encouraged to speak with their health care provider to determine which treatment might work best for them.

For more information about how to live a cancer-fighting lifestyle, explore the NFCR’s website.

Additional Reads You May Enjoy:

Reaching a Stomach Cancer Diagnosis Can Be An ‘Emotional Rollercoaster’

Breakthrough: Single-Cell Sequencing

5 Questions About Nutrition and Cancer with an Oncology Dietitian

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1 Peddicord, S. (2020, April 1). FDA Requests Removal of All Ranitidine Products (Zantac) from the Market. Retrieved October 13, 2020, from https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market

2 Gagne, J. (2019, October 23). Popular heartburn drug ranitidine recalled: What you need to know and do. Retrieved October 13, 2020, from https://www.health.harvard.edu/blog/popular-heartburn-drug-ranitidine-recalled-what-you-need-to-know-and-do-2019092817911