FDA Wants Recall of Zantac and Axid Amid Cancer Concern
Carah Wertheimer · November 5, 2019
Zantac, a commonly used heartburn medication, can contain the carcinogenic toxin NDMA, prompting the FDA to issue a voluntary recall.
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[text] => Recent tests show Zantac may contain the carcinogen NDMA.
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[text] => Heartburn, GERD, stomach ulcer diseases
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[meta_description] => The Food and Drug Administration (FDA) called for voluntary recalls of both ranitidine and nizatidine drugs that had unsafe levels of NDMA, which may be carcinogenic.
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[text] => Ranitidine and nizatidine, known respectively by their brand names Zantac and Axid, are commonly used drugs to treat heartburn, gastroesophageal reflux disease (GERD), and other stomach ulcer diseases.
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[text] => Earlier this year, an online pharmacy reported that they detected N-nitrosodimethylamine (NDMA) in ranitidine drugs on the U.S. market. After a preliminary investigation, the Food and Drug Administration (FDA) called for voluntary recalls of both ranitidine and nizatidine drugs that had unsafe levels of NDMA.
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[text] => Ranitidine and nizatidine are drugs that treat conditions related to aggravation of stomach acid that can eat away at the lining of the stomach and throat and cause irritation, pain, damage to body tissues. Both drugs can be found as prescriptions for long term issues requiring higher doses or as over the counter drugs for short term issues requiring lower doses.
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[text] => Ranitidine is one of the most commonly used drugs in the United States, accounting for well over fifteen million prescriptions and hundreds of millions of dollars in sales as over the counter purchases.
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[text] => With rising rates of obesity and the prevalence of higher fat diets and larger portion sizes, increasing numbers of Americans are experiencing heartburn or are developing GERD from chronic exacerbation by stomach acid. While not nearly as commonly used as ranitidine, nizatidine is also experiencing a similar rise in usage rates by patients.
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[text] => Ranitidine and nizatidine are both histamine H2 receptor antagonists. These drugs work by blocking histamine from connecting with their receptors and preventing them from triggering. The end result is a decrease in the secretion of stomach acid, and relief from conditions like heartburn, GERD, and stomach ulcers.
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[text] => NDMA, also known as dimethylnitrosamine (DMN), is an organic compound that is classified by the FDA and the International Agency for Cancer Research of the World Health Organization as a probable carcinogen for humans. NDMA was labeled as a probable carcinogen after trials on rats demonstrated the development of tumors after long term exposures. NDMA can also be toxic if consumed in extreme amounts.
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[text] => When NDMA is consumed by humans, it undergoes a transformation in the liver into a molecule that can damage DNA and with long term exposure lead to the development of cancer. According to a 2016 article published in the Chinese Journal of Epidemiology, NDMA has been linked to both gastric and colorectal cancers.
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[text] => NDMA most often occurs as a byproduct of industrial processes. The precursor to NDMA can leach into drinking water sources, where water treatment by chlorination can convert it to NDMA. NDMA does not degrade easily and requires additional careful treatment to remove from water sources. NDMA can also enter water sources as a pesticide contaminant.
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[text] => NDMA is also found in significant levels in tobacco smoke and chewing tobacco products, and in lower levels in cured meats, cheeses, beer, vegetables, and other foods.
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[text] => NDMA has not been found in ranitidine and nizatidine products at a high enough level to cause immediate adverse effects, but it has been found in these products beyond the safe daily limit for carcinogenic exposure. Long term exposure to these NDMA contaminated products would place a patient at a higher risk for developing cancer.
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[text] => Ranitidine was created in the 1970s by the Glaxo pharmaceutical company (now known as GlaxoSmithKline) as an improvement over cimetidine, with fewer adverse effects and better and longer therapeutic effects.
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[text] => Nizatidine was created in the 1980s by the pharmaceutical company Eli Lily, likely being the last of the histamine H2 receptor antagonists discovered before the advent of proton pump inhibitors, which treat the same conditions.
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[text] => The FDA started a preliminary investigation after being alerted by online pharmacy company Valisure that several ranitidine products had detectable and unsafe levels of NDMA.
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[text] => Until the FDA issues new guidance on the state of ranitidine and nizatidine products, the FDA has suggested that patients seek alternatives to treat heartburn, GERD, stomach ulcers, and related conditions.
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[text] => The FDA issued their first safety alert to the public that their initial tests had confirmed detection of NDMA in ranitidine products, but stated that levels were within safe thresholds. They initially attributed NDMA contamination of ranitidine products to possible manufacturing issues. Following that first alert, the FDA began issuing a series of alerts about voluntary recalls by pharmaceutical companies and distributors as they continued their testing of ranitidine products.
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[text] => The FDA issued an update that stated further testing of ranitidine found unacceptable levels of NDMA. They also stated that testing methods used by third party laboratories that were intended to test for NDMA in angiotensin II receptor blockers (ARBs) were not appropriate for ranitidine testing. In their statement they reiterated that they had issued an alternative testing method.
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[text] => The FDA issued another alternative testing method and reemphasized alternatives to ranitidine that are available over the counter.
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[text] => However, in the accompanying November 1 release of laboratory testing results, the FDA had collected so far, several ranitidine and nizatidine products had levels of NDMA well above acceptable daily levels. The FDA declined to issue a mandatory recall, instead continuing to rely on voluntary recalls by pharmaceutical companies.
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[text] => The FDA so far has only found concerning levels of NDMA in ranitidine and nizatidine products. With a voluntary recall, patients are dependent on manufacturers or distributors to test their products and withdraw them if NDMA contamination is found. Major drugstore chains like Walmart, Walgreens, and CVS have already withdrawn Zantac and generic versions of ranitidine.
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[text] => The FDA currently lists the following drugs as NDMA-free: famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec). Due to greater side effects, it is advised that cimetidine not be used as a first choice alternative to ranitidine or nizatidine.
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[text] => NDMA can be detected by testing blood and urine samples, and if patients are concerned about exposure to unsafe levels of NDMA they should discuss testing with their physician.
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[text] => On Nov. 1, the FDA asked manufacturers to voluntarily recall antacids containing ranitidine and nizatidine, which are chemically similar, if the agency or manufacturers find they contain unacceptable levels of the contaminant and potential carcinogen NDMA.
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[text] => Ranitidine and nizatidine are used for heartburn, ulcers, gastroesophageal reflux disease and other indications. Rinatidine is the active ingredient in brand name Zantac and its generic formulations. Nizatidine is sold over-the-counter under the brand name Axid although there is a generic form of the prescription version.
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[text] => Until recently ranitidine has been widely prescribed to infants and adults due to its perceived safety.
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[text] => However, the FDA has found unacceptable levels of NDMA in some ranitidine syrups, which are primarily used for newborns and children. These medicines are being recalled.
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[text] => “We understand the concern we’ve been hearing from parents and pediatricians, and we’ll continue to investigate,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in the statement which was issued in her name.
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[text] => NDMA (nitrosamine N-nitrosodimethylamine) is known to cause cancer in laboratory animals and has been classified by the International Agency for Cancer Research of the World Health Organization as “probably carcinogenic to humans.” NDMA can occur as a byproduct of industrial processes and can be present as a pesticide contaminant. Everyday exposures can come from drinking water, tobacco smoke and chewing tobacco, cured meats, cheese, beer, vegetables and other foods.
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[text] => How Concerned Should Consumers Be?
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[text] => The FDA investigation test summary indicates that the agency found NDMA levels as much as seven (Zantac 150 mg OTC) and nine times (Novitium ranitidine 300 mg) higher than the agency’s own acceptable NDMA exposure limits of .032 parts per million.
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[text] => There’s some confusion as to how this translates to actual health risk for consumers.
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[text] => “Through our testing so far, we have found levels of NDMA in ranitidine that are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats,” Woodcock stated.
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[text] => The agency advised concerned prescription users to consult with their health care providers regarding alternatives.
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[text] => The issue began on Sept. 13, when the Food and Drug Administration (FDA) first alerted the public that over-the-counter heartburn drugs containing ranitidine may contain NDMA.
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[text] => The FDA September statement came four days after the agency had received a citizen petition requesting that the agency issue a ranitidine recall and take related consumer health safety measures. The petition was filed by online pharmacy Valisure, which had detected extremely high levels of NDMA in ranitidine during routine internal drug batch testing.
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[text] => The FDA responded with its own investigation, initially detecting very low levels of NDMA that the agency said barely exceeded the amounts commonly found in foods.
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[text] => The FDA attributed the levels of NDMA that Valisure found — more than 3,000,000 nanograms per tablet — on Valisure’s high-temperature testing methods which it said was intended for heart failure and blood pressure medications known as ARBs.
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[text] => On Oct. 2 the FDA reversed course and reported that it had found “unacceptable levels” of NDMA in ranitidine samples, regardless of testing methods.
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[text] => Confusion Over the Source of NDMA Contamination
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[text] => Last year the FDA recommended numerous recalls of the widely prescribed ARB (angiotensin II receptor blocker) heart failure and blood pressure medications valsartan, losartan and irbesartan, all of which were manufactured overseas and contaminated with low levels of NDMA attributed by the agency to manufacturing quality issues.
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[text] => The FDA initially attributed NDMA ranitidine contamination likewise to a manufacturing issue. However, Valisure asserted otherwise.
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[text] => “Valisure’s research, along with that of Stanford University and others, found that NDMA was the result of the ‘inherent instability’ of the ranitidine molecule,” according to a Valisure blog post.
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[text] => Valisure researchers reported that all medications containing ranitidine, brand or generic, could “generate very high levels of NDMA in the human body.”
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[text] => In the Nov. 1 statement, Woodcock said that the agency has not detected the formation of NDMA from ranitidine in its tests which simulate what happens to ranitidine in the stomach and in the small intestine.
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[text] => “However, we still must test the drugs in the human body to fully understand if ranitidine forms NDMA,” she stated.
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[text] => Some Companies Took Prior Action
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[text] => Retailers including Walmart, Walgreens, CVS and Rite Aid stopped selling Zantac and ranitidine. At least five generic manufacturers also issued prior voluntary recalls and Sanofi, the French manufacturer of Zantac, implemented a recall of its over-the-counter product.
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[text] => New studies link acid reflux drugs to infection. PPI risks also include CKD, magnesium deficiency, dementia, bone loss and heart attacks.
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[meta_description] => New studies link acid reflux drugs to infection. PPI risks also include CKD, magnesium deficiency, dementia, bone loss and heart attacks.
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[text] => In 2012, the Food and Drug administration (FDA) issued a drug safety communication that focuses on proton pump inhibitor risks, linking Clostridium difficile with exposure to acid reflux and heartburn drugs. A recent study has expanded on that link.
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[text] => New research shows that medications like Prilosec, Prevacid, and Nexium may increase the likelihood of developing another dangerous gut infection: Campylobacter bacteria.
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[text] => What are proton pump inhibitors?
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[text] => Proton pump inhibitors (PPIs) are over-the-counter medications used to treat gastroesophageal reflux disease (GERD) and symptoms of heartburn. PPIs, which are used by an estimated 15 million Americans, work by suppressing the biological pump that produces stomach acid for digesting food.
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[text] => Long-term PPI risks also include chronic kidney disease, magnesium deficiency, dementia, bone loss, and heart attacks.
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[text] => Data Takeaways
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[text] => A new PPI study published in the British Journal of Clinical Pharmacology found an association between H2 receptor blockers and an increased risk of the bacterial infections C. difficile (C. diff) and Campylobacter bacteria. Those medications include Zantac, Pepcid, and Tagamet.
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[text] => The researchers measured data from a population of nearly 565,000 Scottish adults recorded between 1999 and 2013. Approximately 188,000 patients had prescriptions for PPIs or H2 receptor blockers.
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[text] => Data illustrates that people who used the drugs were four times more likely to suffer from a Campylobacter infection, while being 70 percent more likely to be diagnosed with C. diff outside of a hospital, and 42 percent more likely to develop an infection while hospitalized.
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[text] => The research shows that PPIs alter stomach acid production, which would more easily invite gastrointestinal infections. Because stomach acids are linked to the regulation of gut bacteria, altered production may ultimately affect overall health in sensitive individuals.
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[text] => In 2011, the FDA published a safety announcement that linked the use of PPIs to C. diff. After analyzing observational data in 26 publications, the FDA found that 23 studies illustrated a higher risk of C. difficile infection when patients have been exposed to PPIs.
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[text] => The FDA concluded that most studies found the risk 1.4 to 2.75 times higher among patients taking PPI medications.
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[text] => According to the announcement, “A diagnosis of CDAD should be considered for patients taking PPIs who develop diarrhea that does not improve".
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[text] => According to the Center for Disease Control and Prevention (CDC), C. diff caused an estimated 500,000 U.S. infections in 2011, and 29,000 people died within 30 days. C. diff often affects people taking antibiotics.
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[text] => Campylobacter, however, is a foodborne illness most commonly caused by ingesting undercooked meats. The bacteria lives in the intestinal tract of poultry and cattle, spreading to humans who consume the infected food.
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[text] => The CDC estimates that Campylobacter infects over 1.3 million Americans each year. The bacteria is especially dangerous for individuals with weakened immune systems, such as the elderly. When Campylobacter spreads to the bloodstream, it can be life-threatening.
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[text] => Some patients with gut illnesses may develop more serious intestinal conditions. In addition to common side effects, stomach infections can cause complications that may be fatal. Side effects linked to gut infections include, but are not limited to:
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[text] => Surgical director Dr. F. Paul Buckley from the Acid Reflux Center at the Scott & White Clinic in Round Rock, Texas is one of many doctors to assert that many people taking PPIs don’t actually need them, which may create an unnecessary patient risk. Millions of people take heartburn medications after each meal.
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[text] => Despite the research linking long-term use to a number of PPI risks, the medications are often overprescribed.
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Most Popular Results for “Zantac”
Researchers Link Heartburn Medications to Higher Risk of Gut Infection
Ashley Lombardo · January 11, 2017
New studies link acid reflux drugs to infection. PPI risks also include CKD, magnesium deficiency, dementia, bone loss and heart attacks.
Research + Findings