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Zantac Lawsuit Update: January 9, 2020 - Researchers Find NDMA in Zantac Can Develop During Storage
Emery Pharma says that recent tests indicate that levels of NDMA – a known carcinogen – in Zantac can increase during storage, especially if the drug is exposed to high heat and even while it remains in the package. The researchers found that stored Zantac medication exposed to high heat can produce unacceptably high levels of NDMA in as few as five days.
Based on these findings, Emery Pharma has urged the FDA to recall Zantac and all similar ranitidine drugs.
“The more you heat it, the more NDMA you generate,” Emery CEO Ron Najafi s. “I am worried that if it just sits at home at room temperature, it could gradually generate NDMA.”
Najafi has worked as an expert witness on a number of NDMA drug contamination litigations, including the litigations on NDMA in Zantac and its generic forms.
A Citizen Petition has been filed by Emery Pharma, requesting that the FDA suspend sales and recall all ranitidine-based products due to the threat of NDMA exposure to consumers.
"Our preliminary data indicate that NDMA accumulates in ranitidine-containing drug products on exposure to elevated temperatures, which would be routinely reached during shipment and during storage. More importantly, these conditions occur post-lot release by the manufacturer. Hence, while NDMA levels in ranitidine may be acceptable at the source, they may not be so when the drug is purchased and subsequently at the time of consumption by the consumer," the petition says.
Najafi suggests that these ranitidine-containing products should be shipped and stored using temperature-controlled methods. He also says that the manufacturers and the FDA should continue to conduct stability testing for all products.
FDA spokesman Jeremy Kahn says that the agency will review Emery Pharma’s Citizen Petition and respond directly to the group.
Over the past few months, the FDA has been working to determine whether dangerous levels of NDMA are present in Zantac or its generic forms. Their research has proven to show varying levels of NDMA in products.
Valisure filed a similar Citizen Petition in October after their tests indicated that heat from manufacturing can create high levels of NDMA. According to Valisure, they tested a number of ranitidine-containing heartburn medications and all of the batches tested, regardless of dose forms, “detected extremely high levels” of NDMA in every lot.
In response, the FDA asked drug-makers to test all batches of ranitidine-containing products that they produce to ensure consumers are not exposed to dangerous levels of NDMA.
Many of the manufacturers discontinued the production and sales of their ranitidine-containing drugs after conducting these tests.
The makers of Zantac, a popular over-the-counter and prescription heartburn medication, are facing a class-action Zantac lawsuit claiming the drug contains unsafe levels of the cancer-causing substance N-Nitrosodimethylamine (NDMA).
The U.S. Food and Drug Administration (FDA) reported an advisory on September 13, 2019, after discovering the carcinogenic contaminant NDMA in ranitidine, the active ingredient in Zantac, at levels between 3,000 to 26,000 times higher than FDA approved standards.
NDMA is a potential hepatotoxic, and exposure has been linked to numerous complications and symptoms ranging from bladder cancer, stomach cancer, liver fibrosis and scarring, and tumors in the liver, kidneys, and lungs. Other symptoms of NDMA exposure include headaches, fever, nausea, jaundice, vomiting, abdominal cramps, enlarged living, dizziness, and reduced function of the liver, kidneys, and lungs.
Plaintiffs accuse drugmakers Sanofi and Boerhringer Ingelheim of manufacturing and marketing a medication they knew, or should have known, to be contaminated with the cancer-causing chemical without disclosing the risks to consumers or the government.
The makers of Zantac, a popular heartburn medication, are facing class-action lawsuits claiming the drug contains unsafe levels of the cancer-causing substance N-Nitrosodimethylamine (NDMA).
Zantac is the trade name for Ranitidine, a popular medication that reduces the body’s production of stomach acid. The medication is commonly used to treat and prevent ulcers of the stomach and intestines as well as gastroesophageal reflux disease (GERD), Zollinger-Ellison syndrome, peptic ulcer disease, acid indigestion, and heartburn.
Zantac is available both over-the-counter and by prescription. Ranitidine belongs to h2 (histamine-2) blockers class of drugs. OTC Zantac is most commonly used to relieve and prevent heartburn, while the prescription-strength drug is used to prevent more serious ulcers and conditions. The drug came into commercial use in 1981 and is now the 50th most prescribed medication in the United States.
The FDA acceptable threshold of daily NDMA intake is set at below 100 nanograms. The plaintiffs cited a study that claims that a 150-milligram pill of Zantac contains over 2.5 million nanograms of NDMA. Over the counter Zantac is typically sold in 150-milligram tablets; the recommended dosage to treat peptic ulcer disease for adults is 300 milligrams a night for four to eight weeks.
Plaintiffs allege that Sanofi and Boehringer Ingleham knew the risks of NDMA formation in ranitidine and did not alert the public through the drug’s label or through any other means. Several published studies have shown that ranitidine users have a 400-fold increase of NDMA concentration in their urine. The suit attests that had consumers known the risks, they would not have purchased or consumed ranitidine.
NDMA, n-nitrosodimethylamine, is a potential hepatotoxic, and exposure has been linked to numerous complications and symptoms ranging from bladder cancer, stomach cancer, liver fibrosis and scarring, and tumors in the liver, kidneys, and lungs. Other symptoms of NDMA exposure include headaches, fever, nausea, jaundice, vomiting, abdominal cramps, enlarged living, dizziness, and reduced function of the liver, kidneys, and lungs. The World Health Organization described NDMA as a chemical that is “clearly carcinogenic.”
The U.S. Food and Drug Administration is working alongside regulators and industry partners to discover the source of impurities in ranitidine. The FDA is examining ranitidine NDMA levels and evaluating the potential risk to patients. The investigation is ongoing, and the agency plans to take appropriate measures.
Currently, the FDA is not calling for patients to stop taking ranitidine and the agency has not requested that the manufacturers recall the product. However, some companies such as CVS, Walmart, and Sandzo have chosen to voluntarily suspend the sales of Zantac while waiting for results from ongoing tests and research.
At this point in the ongoing investigation, it does not seem that NDMA levels are high enough to cause cancer. NDMA is classified as a probable carcinogen, but it may only cause cancer after exposure to high doses over a long period of time.
That being said, ranitidine is not recommended for long-term use. The FDA suggests patients who wish to discontinue prescription or regular use talk to their health care professional about alternative treatment options. Multiple market-approved drugs exist for the treatment of the same symptoms without potential NDMA exposure. There is no evidence that other H2 blockers or other heartburn medications are affected by potentially unsafe NDMA impurities.
Class action lawsuits have been filed alleging that Zantac users have been exposed to unsafe levels of n-nitrosodimethylamine (NDMA). If you took Zantac and have been diagnosed with bladder cancer or stomach cancer, we will work to seek the following damages for you:
A class-action lawsuit can help those affected by NDMA levels in ranitidine. A successful class-action lawsuit can help those who used Zantac get back the money they spent on the medication while making a stronger litigation case against manufacturers. This can help ensure stronger future consumer protections, updated labeling, and recalls of drugs with adverse levels of NDMA.
Consumers and health care professionals are urged to report any adverse ranitidine to the FDA through the agency’s MedWatch program. This will help the agency in its research of the drug and to better understand any potential hazards associated with the drug.
Filing a Zantac lawsuit is no different than filing any other type of personal injury lawsuit, so familiarize yourself with the steps of the civil litigation process before you begin.
The first step in a Zantac lawsuit is hiring a personal injury attorney who has experience handling bad drug litigation. In the unfortunate event that you are representing a loved one who has died as a result of injuries from Zantac, you may need to consult with a wrongful death attorney who has knowledge of the Zantac lawsuit.
Your Zantac lawyer will help you to identify who holds liability for your injuries. You will need to begin gathering evidence as soon as possible to support your claim against this liable party. This evidence will help to prove the total cost of losses that you endured as a result of your injury, also known as your damages. In many personal injury lawsuits, the injured party will choose to file for both compensatory damages and punitive damages. After assessing all damages that you incurred, your Zantac attorney will file a complaint demanding compensation to repay your damages.
At TorHoerman Law, our team of personal injury attorneys is available any time to discuss your Zantac lawsuit. We offer free no-obligation case consultations for all potential clients. Our services are based on contingency fees, so we never charge our clients a dime until they have received compensation first. Contact TorHoerman Law to find out how we can serve you today.
November 15, 2019 - In the past week, three generic Zantac drugs have been recalled from pharmacy shelves across the U.S as concern grows that the popular heartburn and ulcer drug Zantac is linked to an increased risk of cancer.
On Tuesday, Amneal Pharmaceuticals recalled dozens of lots of Ranitidine Tablets and Ranitidine Syrup - Specifically, all lots of 150 mg and 300 mg tablets, and 15mg/ml syrup were pulled from the market.
The decision was made amid concerns that the Ranitidine Tablets and Ranitidine Syrup contain dangerous amounts of N-Nitrosodimethylamine (NDMA), a probable human carcinogen, above the limit established by the FDA.
So far, there have been nine Ranitidine recalls.
According to Amneal Pharmaceuticals, no adverse events have been reported as a result of this recall, to date.
Amneal’s Ranitidine follows two similar Ranitidine recalls, all occurring within a week.
Aurobindo Pharma USA issued a recall of both Ranitidine Capsules and Ranitidine Syrup the prior Wednesday.
American Health Packaging issued a recall for Ranitidine Syrups two days later, on Friday.
November 10, 2019 - The United States Food and Drug Administration (FDA) has issued warnings about cancer risks associated with the popular stomach acid medication Zantac. USA Today reports the FDA found unacceptable levels of the probable carcinogen NDMA, or nitrosodimethylamine while testing Zantac and its generic, ranitidine, in September.
Zantac has been routinely used by heartburn sufferers for decades, leading consumers to question how the drug became a potential carcinogen.
Zantac was prescribed more than 15 million times a year without safety concerns prior to the FDA’s announcement. The agency wants manufacturers to test and recall drugs to see if NDMA levels exceed standards. Investigations still seek to determine if Zantac and ranitidine users face greater cancer risk, but the agency said consumers might want to choose different medications. The FDA found no NDMA in over-the-counter alternatives such as Pepcid, Tagamet, Nexium, Prevacid, and Prilosec.
How did such a popular over-the-counter drug become a potential cancer risk?
The agency is still working to determine how the carcinogen is formed. FDA officials are testing samples and publishing standards for worldwide regulators and drug manufacturers. Many chemists believe that ranitidine is reacting with something else during manufacturing, finishing, or in storage. The FDA also asked pharmaceutical companies to examine if the drug’s ingredients are exposed to nitrites during manufacturing.
The FDA and independent agencies have conducted studies on ranitidine in the stomach and intestine with inconclusive results. The FDA studied how ranitidine reacts with stomach and intestine fluids and found no evidence that Zantac formed carcinogens. However, Valisure, an independent online laboratory, and pharmacy tested Zantac in stomach-like fluids with added nitrates commonly found in the body and in foods. With nitrates added, Valisure found one tablet of Zantac exceeded the FDA’s NDMA threshold 3,100 times.
Following the agency’s announcement, many retailers and drugmakers took action. Health Canada stopped distributing the drug. Sanofi, a French drugmaker, recalled the drug from retail shelves and drugstores. Germany, Italy, and Switzerland did the same. Taiwan instituted a fine for any pharmacy with ranitidine on its shelves, and Pakistan banned the drug’s distribution and manufacturing.
In the United States, eight companies pulled ranitidine from their shelves. These included pharmaceutical companies and generic ranitidine drugs from Kroger and Walgreens. Despite the voluntary recalls, the FDA took a more measured approach, asking manufacturers to recall the drugs if NDMA exceeds standards after testing.
Zantac was approved for mass markets in 1984, and researchers at Valisure said the drug’s potential risks can be found in medical studies close to its inception. Valisure CEO David Light said the risk appears to be in the drug itself, instead of as a manufacturing byproduct, and that the problem has been there since the 1980s. In a petition to the FDA, Valisure cited the 1987 study on the concerns of ranitidine conducted by Glaxo Research Group, Zantac’s original research group.
The 1987 Glaxo study examined the stomach contents of people who took Zantac. The study found no significant increase in NDMA in users, but Light claimed the study was not accurate. Light said researchers discarded stomach samples that contained ranitidine and used less accurate testing methods. Light said researchers would not find NDMA without those samples.
While researchers and other agencies seek to determine if Zantac contains unsafe levels of NDMA, the FDA extended voluntary recalls to nizatidine, a similar drug sold under the brand name Axid, if testing shows it exceeds NDMA daily limits. NDMA was also the carcinogen that led to the July 2018 recall of valsartan and losartan, two popular blood-pressure-lowering medications.
At this point in investigations, the FDA is not calling for patients to stop taking ranitidine and the agency has not requested a manufacturer recall. Some companies have voluntarily suspended Zantac sales while waiting for results from ongoing tests and research. NDMA is classified as a probable carcinogen, but it does not see that NDMA levels are high enough in Zantac to cause cancer. However, ranitidine is not recommended for long-term use and the FDA suggests patients talk to a health care professional about alternative treatment options.
Alltucker, Ken. “Zantac Is Prescribed 15 Million Times a Year. So How Did It Become a Potential Cancer Risk?” USA Today, Gannett Satellite Information Network, 10 Nov. 2019, www.usatoday.com/story/news/health/2019/11/07/how-did-zantac-become-potential-cancer-risk-fda-wants-find-out/2509043001/.
Johnson, Carolyn Y. “A Tiny Pharmacy Is Identifying Big Problems with Common Drugs, Including Zantac.” The Washington Post, WP Company, 8 Nov. 2019, www.washingtonpost.com/science/a-tiny-pharmacy-is-identifying-big-problems-with-common-drugs-including-zantac/2019/11/08/6dd009ca-eb76-11e9-9c6d-436a0df4f31d_story.html.
Office of Regulatory Affairs. “Recalls, Market Withdrawals, & Safety Alerts.” U.S. Food and Drug Administration, FDA, www.fda.gov/safety/recalls-market-withdrawals-safety-alerts.
Palmer, Eric. “Lab Finds NDMA in Zantac Can Develop during Storage.” FiercePharma, 3 Jan. 2020, www.fiercepharma.com/manufacturing/lab-finds-ndma-zantac-can-develop-during-storage-bloomberg.
Tegna. “New Generic Zantac Recall over Cancer Fear Makes It 3 in Past Week.” WBNS-10TV Columbus, Ohio | Columbus News, Weather & Sports, 13 Nov. 2019, www.10tv.com/article/new-generic-zantac-recall-over-cancer-fear-makes-it-3-past-week-2019-nov.
Last Modified: January 23rd, 2020 @ 05:56 pm
A Zantac lawsuit has been filed on behalf of those individuals who have developed cancer as a result of Zantac. The makers of Zantac, a popular over-the-counter and prescription heartburn medication, are facing a class-action Zantac lawsuit claiming the drug contains unsafe levels of the cancer-causing substance N-Nitrosodimethylamine (NDMA).
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