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FDA wants ranitidine (Zantac) Pulled from the Market

FDA Asks for All Ranitidine Products (Zantac) to Be Removed from the Market

On April 1, the U.S. Food and Drug Administration (FDA) requested that manufacturers immediately withdraw from the market all prescription and over-the-counter (OTC) ranitidine drugs, commonly known by the brand name Zantac. As a result, ranitidine products will not be available for new or existing prescriptions or OTC use in the United States.

Ranitidine is widely used to treat and prevent heartburn. It can also treat gastroesophageal reflux disease (GERD), stomach ulcers, and conditions that cause too much stomach acid. As a generic drug, it’s sold primarily to decrease production of stomach acid.

As early as September 19, 2019, the FDA alerted patients and healthcare professionals that a contaminant known as N-Nitrosodimethylamine (NDMA), suspected to be a human carcinogen, had been found in samples of ranitidine. Since then, the agency has released more than 15 announcements about its investigation into the contamination, several of which called for limited voluntary recalls and culminated in the April 1 request that all ranitidine be removed from the market.

What the FDA testing revealed about Zantac/ranitidine

According to the FDA, the NDMA levels in some ranitidine products increases over time. Furthermore, when the products are stored at higher-than-room temperatures, it could “result in consumer exposure to unacceptable levels of the impurity.” Although the agency didn’t find unacceptable levels of NDMA in many of the samples that were tested, it decided to issue the request because it couldn’t verify under what conditions medications had been stored.

The FDA’s initial tests found low levels of NDMA in ranitidine. Low levels of NDMA can be found in foods and in water but are not expected to increase the risk of cancer; however, sustained higher levels of exposure may increase the risk. More recent testing confirmed the following:

    • NDMA levels increase in ranitidine even under normal storage conditions.
    • NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures products may be exposed to during distribution and handling by consumers.
    • The older a ranitidine product is, the greater the level of NDMA.
    • These conditions may increase the level of NDMA in ranitidine products above the acceptable daily intake limit.

What consumers should do if they’re taking Zantac/ranitidine and/or have it in their home

In addition requesting that manufacturers withdraw ranitidine products from the market, the FDA advises that consumers stop taking any OTC ranitidine tablets or liquid they have at home, dispose of them properly, and not buy more. People who want to continue treating their condition should use other approved OTC products. Patients taking prescription ranitidine should consult their doctors about other options before stopping the medicine.

There are several drugs approved for the same or similar uses as Zantac/ranitidine that do not have the same NDMA risk. To date, FDA testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).

Because of the COVID-19 pandemic, the FDA asks that patients and consumers do not take their medicines to a drug take-back location; instead, they should follow disposal instructions included with their medication or follow the agency’s guidance for safe home disposal.

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