Zantac Recall: How Worried Do You Need to Be?

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.

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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.

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.

Ranitidine isn’t the only drug with NDMA issues. In July 2018, the FDA announced a voluntary recall of various drugs with valsartan, an active ingredient used to treat high blood pressure and heart failure, because the products contained NDMA.

The whole issue with NDMA is that studies suggest it’s a “probable human carcinogen,” meaning it has the potential to cause cancer. But the studies in humans linking NDMA to cancer have found a relatively weak link so far.

A 2015 meta-analysis in Nutrients looking at 49 studies on dietary nitrates, nitrites, and NDMA found that a “high” dietary level of NDMA consumption was associated with an increased risk of gastric cancer. The odds of developing this cancer were about 34 percent greater for those with a “high” intake of NDMA than those with a “low” intake. That sounds like much higher chances, but in scientific terms, that’s an odds ratio, or OR, of 1.34. For context, examinations of smoking as a risk for different types of lung cancers tend to show ORs of 20 to 100 or greater, so an OR less than 2 isn’t a particularly substantial risk factor. While the meta-analysis had its strengths, like analyzing over 740,000 people in the NDMA studies, it also had limitations, like a broad range of what “high” and “low” intakes meant across different studies.

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Then there’s a large study published in Carcinogenesis in 2019, which found that NDMA intake was associated with an increased risk of developing pancreatic cancer. Researchers collected questionnaires on the frequency of eating certain foods high in NDMA (like fermented cheese and beer), along with portion sizes, from 957 people with pancreatic cancer and 938 people without pancreatic cancer. They found 93 percent greater odds of cancer development in people who ate those foods more frequently than in controls. Sounds shocking, but that’s still an OR of 1.93, which, again, is relatively low. This study had its own strengths, like the detail in the food questionnaires, and limitations, like the fact that the data from those questionnaires were still self-reported and that researchers couldn’t completely isolate the possible impact of NDMA from the potential health implications of eating certain foods in various amounts.

A 2018 BMJ study in Denmark of 5,150 individuals who took potentially NDMA-contaminated valsartan found no significant increase in short-term overall cancer cases compared to patients who had not been given the drug, but the researchers noted that more studies will be necessary to examine the potential long-term effects and look into associations with specific cancers.

What if you’re currently taking Zantac?

The FDA isn’t currently recommending that people using ranitidine stop taking it. When SELF reached out to the FDA for comment, they declined an interview but responded with text included in their public statement from September 26.

“FDA is not recommending individuals stop taking all ranitidine medicines at this time,” the statement says. “Consumers taking OTC ranitidine could consider using other OTC products approved for their condition. Patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options. Multiple drugs are approved for the same or similar uses as ranitidine.”

If you were only taking ranitidine occasionally, you could switch to another H2 blocker, Scott Gabbard, M.D., a gastroenterologist at the Cleveland Clinic, tells SELF. The FDA notes in its statement that testing of the H2 blockers Pepcid (famotidine) and Tagamet (cimetidine) has shown no NDMA contamination. Or you could consider using something like an antacid, which can also be very effective in the short-term and typically provides almost immediate relief.

If you were taking heartburn drugs with ranitidine more than twice a week, a different class of medications than H2 blockers may actually make more sense for you. “Patients develop tachyphylaxis within a week or two of taking [H2 blockers] on a daily basis, meaning they work for a few days but if you take them [daily] your body gets used to them,” Dr. Gabbard says. “Stomach acid levels go right back to baseline…so they’re not very good medicines to be on long-term.” (They’re better for short-term situations like after Thanksgiving dinner, Dr. Gabbard says.)

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So if you need longer-term treatment and would rather not use ranitidine, consider talking to your doctor about other options, like proton pump inhibitors. These drugs block the enzyme system responsible for secreting gastric acid. Unlike H2 blockers, the efficacy of proton pump inhibitors does not decrease over time, so they’re typically a better option for longer-term treatment. According to the FDA, testing of the proton pump inhibitors Nexium (esomeprazole), Prevacid (lansoprazole), and Prilosec (omeprazole) has shown no NDMA contamination.

How worried do you really need to be about ranitidine and cancer?

If you’ve been relying on a drug with ranitidine to deal with heartburn for who knows how long, try to remember that the chances you’ll develop cancer because of this are overall extremely low. “Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods,” the FDA says.

With that said, you should get in touch with your doctor for an evaluation if you experience any strange symptoms that concern you. Anything like unintentional weight loss, bloody or tarry stools (which may indicate intestinal bleeding), symptoms of anemia like fatigue and weakness, or new abdominal pain out of proportion to what you experience on a regular basis is worth bringing up with a doctor. If you have any additional cancer risk factors (like a history of smoking) and are really worried, it can be smart to talk to your doctor about your health as well. The same goes if you decide to switch treatment and your heartburn persists or worsens.

The bottom line is that although heartburn can truly be a pain, there are still plenty of treatment options to consider even with some of these ranitidine-containing drugs called into question.

Related:

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