Zantac Recall Update: The FDA Officially Wants Zantac Off Shelves

Health Information Relationships


Update, April 1, 2020: Today, the U.S. Food and Drug Administration (FDA) announced it is requesting that manufacturers withdraw all over-the-counter and prescription drugs containing ranitidine, the active ingredient in Canadian and U.S. forms of the heartburn drug Zantac. This announcement is part of an investigation into N-nitrosodimethylamine (NDMA), a “probable human carcinogen” that has been found in some Zantac products. It appears as though this contamination can become worse over time and also when the product is stored above room temperature. Ultimately, the FDA says, this can expose people taking ranitidine-containing drugs to “unacceptable levels of this impurity,” which prompted the request to withdraw the drug from the market. If you’re taking Zantac for heartburn, the FDA recommends you stop and consider using other products.

Original, October 31, 2019:


If heartburn is the bane of your existence and you rely on Zantac to ward off the pain, you’ll probably be pretty concerned to hear that some forms of the drug have been recalled. For the uninitiated, Zantac is a brand of over-the-counter heartburn treatments and preventive medications made by the pharmaceutical company Sanofi. On September 13, the U.S. Food and Drug Administration (FDA) announced that low levels of a “probable human carcinogen” called N-nitrosodimethylamine (NDMA) had been found in some Zantac products. In light of this news, Sanofi instituted a voluntary recall of all over-the-counter Zantac products in the United States as “a precautionary measure,” according to a public statement from the company. When SELF reached out to Sanofi for comment, a spokesperson responded with text from this statement.

“This [recall] includes Zantac 150®, Zantac 150® Cool Mint, and Zantac 75®,” the statement says. “The company is committed to transparency and will continue to communicate results with health authorities from the ongoing testing, and work with them to make informed decisions based on available data and evidence.” Sanofi also launched a voluntary recall in Canada, as ranitidine, the active ingredient in Canadian and U.S. Zantac, comes from the same suppliers.

After the FDA’s notice, manufacturers that supply ranitidine-based heartburn drugs to pharmacies including Walgreens, CVS, Kroger, Target, Rite-Aid, and Walmart also pulled certain OTC and prescription medications containing this ingredient. On October 28, the FDA announced that three other pharmaceutical companies were voluntarily recalling various ranitidine-containing products as well.

Knowing all of that, if you’ve been a Zantac devotee, you might be thoroughly freaked out and wondering how you should deal with heartburn going forward. Fortunately, you probably don’t need to be too concerned that your past Zantac use will harm you, and you still have many options for treating your heartburn. Keep reading to learn more.

How does ranitidine work?

Ranitidine is an H2 blocker, the U.S. National Library of Medicine explains. H2 blockers work to reduce heartburn symptoms by binding to proteins in the stomach called histamine H2 receptors.

Normally, after you eat, your body releases a hormone called gastrin to aid digestion in some key ways, like by increasing the movement of your stomach so it’s better able to churn food. Gastrin also prompts the release of the chemical histamine, which then binds to H2 receptors and causes the release of gastric acid to help break down that food. All of that is a normal and necessary part of the digestive process.

But if you have heartburn, your lower esophageal sphincter (the muscle that needs to loosen to let what you eat and drink down to your stomach) weakens or relaxes when it shouldn’t. This can cause acid reflux, meaning that gastric acid can enter your esophagus and lead to heartburn. The goal of taking H2 blockers such as ranitidine is to decrease how much of this acid you make so there’s less of it to flow back into your esophagus and cause those signature symptoms.

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What’s the deal with NDMA?

NDMA is a contaminant that can form naturally in the environment or through various industrial or chemical processes, according to the Environmental Protection Agency (EPA). Because of that, it can be found in multiple sources like water, foods such as smoked or cured meats and fish, cosmetic products like shampoo, and cigarette smoke. Clearly, it can also be found in some drugs, like ranitidine. Beyond that, some research suggests that NDMA can also form when your body metabolizes ranitidine, though that’s not definitive.

https://www.self.com/story/zantac-recall-cancer

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