Zantac May Contain Carcinogen, According to FDA

October 2, 2019

In September 2019, a number of popular drug stores in the United States — CVS, Walgreens and Rite Aid — removed the drug Zantac from their shelves due to concerns over contamination with trace amounts of the chemical called nitrosodimethylamine (or NDMA). This comes on the heels of a recent “Product Alert” issued by the U.S. Food and Drug Administration (FDA).

NDMA has been found to have potential human carcinogenic and liver-damaging effects, according to the FDA. Exposure to this chemical has been linked to liver damage, development of cancer, internal bleeding, pregnancy complications and even death, based on findings from a number of animal studies.

Fortunately, there are other ways to manage heartburn that don’t involve relying on such drugs, as described more below.

Zantac’s Potential Link to Cancer

Zantac is a popular over-the-counter medication used to treat heartburn (also called acid reflux), a digestive condition that affects an estimated 60 million American adults each month, and about 15 million nearly every single day, according to the American College of Gastroenterology. It’s classified as an H2 medication, a group which includes other drugs like Pepcid, Tagamet and respective generic equivalents, famotidine and cimetidine.

Heartburn symptoms can include feeling of burning discomfort in the chest (behind the breastbone), neck and throat, sometimes along with other symptoms like a bitter or sour taste in the mouth, and loss of appetite.

Recent findings suggest that Zantac — along with generic forms of the drug, called ranitidine, which work in the same way — may pose a possible risk to consumers if they have been tainted with even small amounts of the chemical called nitrosodimethylamine (NDMA).

What Is NDMA?

There’s evidence that ranitidine products may contain a low level of nitrosodimethylamine (NDMA), which is a probable human carcinogen.

NDMA is a yellow, liquid chemical that’s classified as both a “probable carcinogen” and an environmental contaminant.
It has no distinct smell or taste, so consumers wouldn’t know that they were ingesting it if drugs they were taking contained the chemical.
The FDA says that NDMA is “unintentionally formed during various manufacturing processes at many industrial sites.” It can make its way into air, water and soil from reactions involving other chemicals called alkylamines.
It’s believed that people are primarily exposed to NDMA by drinking contaminated water and eating contaminated foods. Exposure has been found to occur due to intake of: tobacco smoke and chewing tobacco, certain foods like cured meats such as bacon, beer, fish and cheese, use of some toiletry and cosmetic products, and use of household detergents and pesticides.
NDMA can also form in the stomach when someone eats foods containing alkylamines, which are naturally occurring compounds which are found in some drugs and in a variety of foods.
Occupational exposure is another concern; people who work in industries such as tanneries, pesticide manufacturing plants, rubber and tire manufacturing plants, alkylamine manufacture/use industries, fish processing industries, foundries, and dye manufacturing plants may come into contact with more NDMA than the general population.
Use of medications, including Zantac, has now been added to the list of ways that NDMA makes its way into the human body.

Why Is NDMA Potentially Harmful to Our Health?

Studies conducted in animals suggest that NDMA enters the bloodstream and quickly makes its way to organs located throughout the body. It is broken down into other substances in the liver and usually leaves the body within about 24 hours, through exhaled air and urine.

NDMA has been shown to be very harmful to the liver, capable of causing severe liver damage and internal bleeding. It can contribute to development of serious, noncancerous liver disease, as well as liver cancer and lung cancer according to animal studies.

Exposure over long periods of time has also been found to be deadly in animal studies. Most of the research available, however, has been conducted on animals. At this time, there are no reports of NDMA causing cancer in humans, but it’s still considered to be carcinogenic.

Additionally, studies involving mice have shown that NDMA exposure during pregnancy can lead to miscarriage and death of offspring.

FDA Actions

The FDA is in charge of asking manufacturers to test the levels of NDMA in their drugs and send samples to the agency. Some ranitidine products have been found to contain NDMA in small but “above acceptable levels.” The carcinogen has been shown to be present in multiple formulations of ranitidine, not just Zantac.

An article published by the Washington Post explains that at this time the FDA “has stopped short of calling for people to stop taking drug that remains on the market,” but it’s recommended that anyone who has purchased Zantac or who wishes to keep using the drug first discuss the pros and cons of doing so with their doctor.

The FDA reports they will “take appropriate measures based on the results of ongoing investigation.”

Sanofi, the pharmaceutical company that manufactures Zantac, has not yet officially recalled the drug. Other H2 blockers will also still be available to the public, at least for now, such as Pepcid and Tagamet.

Natural Ways to Reduce Heartburn

While the drug may still be available in some stores, for many people with heartburn/acid reflux, taking Zantac regularly is now off the table.

So how should you go about managing your heartburn symptoms? Try these natural and safe heartburn remedies instead:

Focus on making dietary changes. Eat healthy foods that limit inflammation of the digestive tract and that help control how much stomach acid you produce. For example, foods and meals that are capable of aggravating heartburn symptoms include: fried food, refined oils (like canola, safflower, sunflower, corn and soybean oil), packaged foods with artificial sweeteners, preservatives and additives, tomatoes, citrus fruits (oranges, lemons, limes, grapefruit), garlic and onions, chocolate, coffee/caffeine, and alcohol.
Fill up on whole foods like leafy green vegetables, berries, starchy veggies like sweet potatoes, probiotic foods, coconut and olive oil, legumes, nuts and wild-caught fish. Bone broth, herbal teas, aloe vera and apple cider vinegar may also be helpful additions to your routine.
Eat smaller meals, avoiding large heavy meals especially close to bedtime.
Get a handle of chronic stress, which can make GI issues worse. High levels of uncontrolled stress and even a lack of sleep can increase acid production in the stomach. Relaxation techniques like meditation, exercise, deep breathing, massage, acupuncture, journaling, and using relaxing essential oils may all help.
Avoid smoking and taking any medications that can make symptoms worse, such as birth control pills or certain drugs used to treat high blood pressure.
Consider taking supplements that may help ease digestive distress, such as: digestive enzymes, HCL with pepsin, probiotics, magnesium, and L-Glutamine.