Boynton Beach Zantac Lawsuit Filed by Local Woman
James Parker · January 15, 2020
A Florida woman has filed a lawsuit alleging that Zantac manufacturers deliberately allowed an unsafe product to remain on the market.
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[text] => A Florida woman has filed suit against the manufacturers of the Zantac after developing cancer. The Boynton Beach Zantac lawsuit alleges that the manufacturers deliberately allowed an unsafe product to remain on the market.
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[text] => According to the Boynton Beach Zantac lawsuit claim, 44-year-old Jill Goldstein was diagnosed with a hormone receptor-positive ductal carcinoma in Aug. 2019. The following month, Goldstein underwent a lumpectomy, removing the tumor and part of her breast. Goldstein alleges that her regular consumption of Zantac increased her risk of developing cancer by 240%.
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[text] => Using a 2008 study by the Fred Hutchinson Cancer Research Center as evidence, Jill Goldstein filed against the manufacturers of Zantac:
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[text] => The lawsuit alleges the manufacturers are guilty of selling products with design defects, not warning consumers, negligence, breaching an express warranty, breaching an implied warranty, and negligent misrepresentation.
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[text] => The 2008 study Goldstein’s suit references states that consuming ranitidine regularly increases the risk of ductal carcinoma by 2.2 and increases risks of hormone receptor-positive ductal carcinoma by 2.4-fold compared to those with no ranitidine exposure. The study does stipulate that further studies would need to confirm this and could offer no explanation for why ranitidine appeared to increase the risks of cancer.
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[text] => Officials representing Sanofi U.S. have refuted the claims of the Boynton Beach Zantac lawsuit and assured consumers that the company was “working closely with the FDA and other regulatory bodies to evaluate any potential safety risks associated with ranitidine products."
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[text] => What are the alternative options to treat heartburn and related conditions? Here are 5 medications to take instead of Zantac.
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[text] => With the 2019 voluntary recall of ranitidine (brand name Zantac) and nizatidine (brand name Axid) products in the U.S. well underway due to contamination by the carcinogen NDMA, the FDA has listed several alternative drugs to treat heartburn and related conditions.
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[text] => Proton pump inhibitors (PPIs) are a class of drugs that work by irreversibly blocking the secretion of acid into the stomach by specific enzymes. They are more commonly used by patients than the class of drugs that ranitidine and nizatidine belong to as PPIs have been noted to be more effective.
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[text] => There are three PPIs that the FDA lists as alternatives for ranitidine and nizatidine: esomeprazole (brand name Nexium), lansoprazole (brand name Prevacid), omeprazole (brand name Prilosec).
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[text] => PPIs may increase the risk of gastric infections and can also reduce the absorption of magnesium and vitamin B12.
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[text] => Both ranitidine and nizatidine are H2 histamine receptor antagonists, which work by blocking histamine from activating the stomach lining cells that create and secrete acid into the stomach.
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[text] => Fortunately, NDMA contamination appears to just be limited to ranitidine and nizatidine, and there are two other drugs from this class that can work as alternatives. The FDA lists famotidine (brand name Pepcid) and cimetidine (brand name Tagamet).
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[text] => H2 histamine receptor antagonists are pretty well tolerated in general, but cimetidine is particularly associated with a range of adverse effects including gynecomastia, impotence, vitamin B12 deficiency, anemia, thrombocytopenia, neutropenia, and pancytopenia. H2 histamine receptor antagonists can also be associated with altered mental status, headaches, dizziness, and restlessness, especially in older patients.
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[text] => Both classes of drugs should only be taken under physician advisement for the appropriate dose and duration of treatment. Long-term inappropriate use of either drug class can increase the risk of adverse effects. The use of these drugs should also be paired with appropriate lifestyle modifications to reduce exacerbation of stomach acid conditions.
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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 their longest statement to date, commenting that “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.” The FDA tested ranitidine products under conditions found during digestion in the human body and determined no new formation of NDMA from ranitidine, supporting their initial assertion that NDMA might be due to manufacturing issues. They also expanded their testing to nizatidine products.
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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] => In addition to drug alternatives, patients might also find it helpful to use antacids such as Tums to help relieve heartburn. Changes to diet like reducing oversized or high-fat meals, alcohol, and spicy foods can also help prevent aggravation of stomach acid-related conditions.
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[text] => Appco Pharma and Denton Pharma have voluntarily recalled generic versions of Zantac (ranitidine) to align with the FDA's efforts to remove drugs from circulation that may contain more than 96 nanograms of NDMA per million nanograms of ranitidine.
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[text] => Additional recalls of generic versions of Zantac (ranitidine) have been announced in an effort to continue removing drugs from circulation that may contain the cancer-causing chemical N-nitrosodimethylamine (NDMA). Appco Pharma and Denton Pharma, operating as Northwind Pharmaceuticals, have complied with the FDA's recommendations and recalled both 150 and 300-milligram ranitidine products.
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[text] => The FDA ranitidine recall targets any drugs which contain more than 96 nanograms of NDMA per million nanograms of ranitidine. The latest FDA ranitidine recall has also been accompanied by an announcement made on the FDA’s page on Jan. 8, 2020.
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[text] => In the announcement, the FDA shared the findings of California-based lab Emery Pharma that ranitidine appears to form NDMA when exposed to heat. Following this revelation, Emery filed a petition with the FDA to have ranitidine transported in temperature-controlled vehicles, warn consumers if a lot of ranitidine had been exposed to heat, or suspend ranitidine from sale.
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[text] => In early December, the FDA investigation began after similar probes had been launched by the European Unions’ EMA into a range of drugs including the heartburn drug Zantac. During the announcement of the probe, FDA officials reassured consumers that the FDA had found NDMA levels in Zantac approximately equal to those found in grilled or smoked meat.
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[text] => The FDA does expect to find trace amounts of NDMA as it is present in almost all food and water, but elevated levels of the chemical could pose a health risk to consumers. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, told consumers, "The FDA is investigating whether metformin in the U.S. market contains NDMA and whether it is above the acceptable daily intake limit of 96 nanograms."
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[text] => There has been one investigation so far that has found elevated NDMA contamination in metformin. That was an investigation in Singapore that recalled three out of 46 metformin samples tested. Additionally, despite the FDA metformin probe’s actions, regulatory agencies have unanimously agreed that metformin is a vital medication for controlling the early stages of type 2 diabetes and it is more dangerous for patients to stop taking the drug.
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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 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] => 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] => An independent lab has possibly identified the cause of contamination of ranitidine (Zantac) antacid products in the U.S. by the carcinogen N-nitrosodimethylamine (NDMA), after weeks of uncertainty and unfruitful lab testing.
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[text] => Since the late fall of 2019, the FDA has announced a series of voluntary recalls by manufacturers and distributors of ranitidine products in the U.S. after discovering that they had unacceptable levels of NDMA. The FDA has advised that pharmaceutical companies test their drugs after production and not release them to the U.S. market if contamination levels were high enough to expose patients to more than 96 nanograms of NDMA per day.
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[text] => First reported by Bloomberg, new testing by Emery Pharma in Alameda, California demonstrated that a combination of heat and time might be the culprit for contamination. Analysis showed that limited heat exposure would be enough to trigger a rise in NDMA levels through destabilization of the drugs. A sample of ranitidine surpassed the FDA’s 96 nanogram NDMA limit after five days at 158 degrees Fahrenheit (70 degrees Celsius), and by 12 days the sample reached 142 nanograms of NDMA. Emery Pharma also tested the drugs at a common daytime temperature of 77 degrees Fahrenheit (25 degrees Celsius), and found that a sample reached 25 nanograms over 12 days.
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[text] => The analysis by Emery suggests that anything from extended exposure to a warm ambient temperature to a long delivery in a hot truck risks increasing NDMA levels in all ranitidine products. The longer the exposure the higher the contamination levels might rise, increasing the risk that a patient might only need one or a couple doses to expose themselves to a level of NDMA substantially higher than the FDA guideline. As a result, Emery submitted a Citizen Petition to the FDA requesting a total suspension of ranitidine products, a mandatory recall of any product available on the market, stability testing on future products, temperature-controlled delivery, and new warning labels describing the risk of development of carcinogens from heat exposure.
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[title] => Researchers Link Heartburn Medications to Higher Risk of Gut Infection
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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_title] => Researchers Add Gut Infections to Heartburn PPI Risks
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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] => Intestinal Infections
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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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Most Popular Results for “Zantac”
5 Alternatives to Zantac
Benjamin Duong · January 7, 2020
What are the alternative options to treat heartburn and related conditions? Here are 5 medications to take instead of Zantac.
Health Features