Zantac LawsuitHeartburn Medication Linked to Cancer Risk

Zantac Lawsuit

Veterans Prescribed Zantac at the VA have Filed Zantac Lawsuits

November 9, 2020 - Veterans are increasingly filing Zantac lawsuits claiming the drug causes cancer, according to lawyers.

The lawsuits claim drug manufacturers knew the active ingredient in Zantac, ranitidine, had the potential to form a toxic chemical called N-Nitrosodimethylamine (NDMA) in a person’s stomach but did not warn the public. NDMA is known to cause cancer in animals and may cause cancer in humans.

The U.S. Food and Drug Administration asked all manufacturers to withdraw Zantac and all ranitidine products from the U.S. market in April 2020 because the drug could expose people to unacceptable levels of NDMA.

According to lawsuits, scientific literature showed that drugs like Zantac containing a substance called dimethylamine (DMA) were more likely to form NDMA when combined with other substances in the body. This information was available before the FDA approved Zantac in 1983, and lawsuits say drug manufacturers failed to warn the public, exposing them to an increased cancer risk.

Many of the veterans who filed Zantac cancer lawsuits took Zantac prescribed at the VA, according to their lawyers. Because veterans are more likely to take acid-reducing medications, they may be at a higher risk of exposure from Zantac.

Read More Updates

If you or a loved one took Zantac and subsequently suffered injuries including but limited to bladder cancer, pancreatic cancer (pancreatitis), stomach cancer, brain cancer, or other cancers, you may be entitled to compensation for your injuries through the Zantac lawsuit. Contact TorHoerman Law today to discuss your legal options with an experienced Zantac lawyer, free of charge and no obligation required. If you do not qualify for a Zantac cancer lawsuit, you may still qualify for a Zantac class-action lawsuit if you took Zantac and were unaware of the cancer risks associated with the drug.

Want a faster analysis to see if you qualify for a Zantac lawsuit? Use our chatbot below to get an instant online case evaluation free of charge.

 

 

What is Zantac?

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.

 

Zantac Products & Generic Products Containing Ranitidine

These are the most common Zantac products and generic Zantac products containing ranitidine:

  • Zantac 150 Tablets
  • Zantac 150 Maximum Strength
  • Zantac 150 Maximum Strength Cool Mint
  • Zantac 75 Tablets
  • Wal-Zan 150
  • Wal-Zan 75
  • Heartburn Relief
  • Acid Reducer
  • Acid Control

 

 

Zantac FDA Warning – Ranitidine Containing NDMA Poses Cancer Risk

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.

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.

 

 

Zantac Cancer Risk

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 liver, 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.

 

Cancers Caused by Zantac

Plaintiffs in the Zantac class-action lawsuit have a variety of cancers, including:

  • Bladder Cancer
  • Brain Cancer
  • Breast Cancer
  • Esophageal/Nasal/Throat Cancer
  • Intestinal Cancer
  • Kidney Cancer
  • Liver Cancer
  • Lung Cancer
  • Ovarian Cancer
  • Pancreatic Cancer
  • Prostate Cancer
  • Stomach Cancer
  • Testicular Cancer
  • Thyroid Cancer
  • Uterine Canter
  • Other Cancers

 

 

Zantac Recall: Is Zantac Being Recalled?

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.

 

 

Zantac Class-Action Lawsuit Claims Failure to Warn

The makers of Zantac, a popular over-the-counter and prescription heartburn medication, are facing a Zantac class-action 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.

a Zantac class-action lawsuit has been filed against the the manufacturers of concealing adverse health risks associated with Zantac that led plaintiffs to suffering serious injury and death.

 

 

Zantac Cancer Lawsuit Alleges NDMA in Zantac Increased Zantac Cancer Risks

The makers of Zantac, a popular heartburn medication, are facing a Zantac cancer lawsuit claiming the drug contains unsafe levels of the cancer-causing substance N-Nitrosodimethylamine (NDMA) which caused plaintiffs to develop cancer.

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 manufacturer’s failure to warn directly lead to plaintiffs developing a number of life-threatening types of cancer.

 

 

 

Filing a Zantac Lawsuit

A Zantac class-action lawsuit has been filed alleging that Zantac users have been exposed to unsafe levels of n-nitrosodimethylamine (NDMA).

Additionally, individual Zantac cancer lawsuits have been filed claiming that Zantac containing NDMA caused plaintiffs to develop cancer, which was not a potential side effect listed on the Zantac warning label.

Before filing a  Zantac lawsuit, you should familiarize yourself with the steps of the civil litigation process so that you are aware of the process of a Zantac lawsuit.

You should also do everything possible to mitigate your injuries – this includes discontinuing Zantac usage, seeking proper medical care, following the doctor’s orders, and doing everything in your power to minimize the costs and losses associated with any injuries that you have incurred.

The first step in a Zantac lawsuit is hiring a personal injury attorney who has experience handling bad drug lawsuits. 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 prove that liability for your injuries falls on the manufacture using evidence to establish that you incurred losses and or injuries due to Zantac.

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.

 

 

Should I File a Zantac Cancer Lawsuit or Zantac Class-Action Lawsuit?

If you took Zantac and subsequently were diagnosed with cancer, you may qualify for a Zantac cancer lawsuit.

If you took Zantac consistently and did not develop cancer, but were unaware of the cancer risks associated with Zantac, you may be eligible to participate in the Zantac class-action lawsuit.

 

Qualifying For a Zantac Cancer Lawsuit

If you were diagnosed with cancer and took Zantac regularly prior to the diagnosis, contact a Zantac cancer lawyer to discuss your legal options, including filing a Zantac cancer lawsuit.

Your Zantac cancer lawyer can help acquire compensation for the losses you incurred as a result of your cancer. As a client, our team will work to seek the following damages for you:

  • Medical expenses resulting from injuries
  • Future medical expenses resulting from the injuries
  • Pain and suffering, both physical and mental, caused by the injuries, treatment, and recovery period
  • Wage loss, loss of earning capacity
  • Other costs associated with our injuries
  • Loss of enjoyment of life resulting from damages
  • Loss of life
  • Punitive damages against the manufacturer

 

Qualifying For a Zantac Class-Action Lawsuit

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.

 

 

TorHoerman Law, Experienced Zantac Lawyer

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 talk to a Zantac lawyer and learn about your legal options, including filing a Zantac cancer lawsuit or Zantac class-action lawsuit.

 


Litigation Updates

New Class Action Zantac Lawsuit Includes Claims from More Than 200 Zantac Users

September 16, 2020 - More than 200 people recently joined together to file a new Zantac class-action lawsuit in the U.S. District Court for the Southern District of Florida. The plaintiffs bring the action on behalf of themselves and all other similarly situated residents of the U.S. or its territories who purchased and/or used Zantac for personal use.

According to the complaint, Zantac manufacturers deceived millions of consumers into “purchasing and ingesting a defective, misbranded, adulterated, and harmful drug” while failing to warn about the potential for that drug to conatin N-nitrosodimethylamine (NDMA), a cancer-causing agent.

Plaintiffs who used the drug between 1983 until April 2020 when the U.S. Food and Drug Administration removed it from the market now face a potential increased risk of developing cancer, which may require them to endure costly medical monitoring, treatments, and/or medications for the rest of their lives.

The FDA set the maximum allowable daily limit of NDMA to 96 nanograms. Tests on Zantac products, however, revealed much higher than allowed amounts of NDMA, prompting the FDA to notify the public of potential danger in September 2019.

The plaintiffs claim they would never have used the medication if they were aware of its potential to contain NDMA. They say that the defendants knew or should have known of the NDMA risk in their products as early studies showed the possibility of conversion into cancerous N-nitroso compounds. Additionally, the plaintiffs state that the defendants long knew that NDMA could be formed, yet failed to take any action to protect consumers.

The plaintiffs are seeking compensatory and punitive damages.

Zantac Manufacturers Being Investigated by Department of Justice

August 1, 2020 - New commission filings have revealed that Sanofi-Aventis US LLC and GlaxoSmithKline LLC are being investigated by the Department of Justice over allegations that the heartburn drug, Zantac, causes cancer. The DOJ and U.S. Attorney’s Office are specifically looking to see if these companies violated the False Claims Act by failing to reveal their knowledge about the presence of NDMA in their product.

The probes began last month. Around the same time, the New Mexico Attorney General lodged a suit against multiple Zantac manufacturers for having violated the False Advertising Act, the Unfair Practices Act, and other laws.

Zantac cases have already been consolidated in Florida, but attorneys for 40 plaintiffs in California are seeking to have cases consolidated there, as well.

Cancers being attributed to Zantac include testicular, bladder, prostate, kidney, and thyroid. The claims also state that makers of the heartburn drug have known about its potential to cause injuries since the 1980s, and that some even worked to shut down those studies.

Zantac manufacturers continue to deny claims that their heartburn drug causes cancer and say that there is no causal link between Zantac and cancer.

 

Zantac Cancer Lawsuits Consolidated in S Florida District Court

July 5, 2020 - Two Zantac cancer lawsuits have been consolidated in the U.S. District Court of Florida, where the Zantac litigation is pending.

The two plaintiffs, one from Pennsylvania and the other from Florida, are both women who claim that regular use of Zantac lead them (or their descendant) to develop cancer.

The Pennsylvania-based plaintiff filed a claim on behalf of a deceased family member’s estate. The descendant was diagnosed with pancreatic cancer in 2018, succumbing to the illness on August 31, 2019.

According to her complaint, the descendent used Zantac regularly and followed the directions regarding drug usage. The plaintiff’s complaint states that the descendant would have not used Zantac if he was aware of the cancer risks associated with Zantac.

The Florida-based plaintiff’s complaint states that she began taking over-the-counter Zantac regularly more than 20 years ago, using both 75 mg and 150 mg does, initially beginning to use the drug to reduce her stomach acid after undergoing an endoscopy. Similar to the Pennsylvania plaintiff’s claim, the Florida plaintiff states that she used the drug as directed on the label. She began with 75 mg doses but transitioned to 150 mg doses after the higher dose became available in the US market. She also noted that she would have not used Zantac if she was aware of the cancer risks associated with the drug.

The Florida plaintiff was diagnosed with stage IIC colon cancer in April 2018. She subsequently underwent an invasive surgery to have a large part of her colon removed. She has since received various cancer treatments, including chemotherapy treatment.

Both pancreatic cancer and colon cancer have been linked to Zantac use.

Both plaintiffs are seeking compensatory damages as well as punitive damages against the manufacturer.

 

Zantac Users Push to Consolidate Cancer Suits in California

June 9, 2020 – The attorneys representing 40 different Zantac users with cancer are urging the court to consolidate their cases in California. The plaintiffs allege that Sanofi-Aventis US LLC, Pfizer Inc. and other pharmaceutical companies hid the risks of heartburn drug Zantac.

The plaintiffs in the 40 cases filed a petition to have their suits linked in a judicial council coordinated proceeding to consolidate pretrial and trial phases of the cases, which they said would work alongside the existing Zantac multidistrict litigation in Florida.

“Coordinating these two important proceedings is the first step in putting pressure on these defendants to come to the negotiating table and do right by our clients.” Jennifer A. Moore, a representative for the plaintiffs said.

Plaintiffs in the complaints include the mother of an 8-year-old boy who alleges that her use of Zantac while pregnant resulted in her son developing testicular cancer. Other complaints allege the drug also resulted in bladder, kidney, prostate, and thyroid cancer.

Despite knowing the risks associated with taking Zantac, the companies failed to warn its user and advertised the product as medication to take while eating the very foods that would cause that carcinogen, according to the suits.

Furthermore, the lawsuits claim that GlaxoSmithKline LLC, which first created Zantac in the 1970s, worked to discredit studies in the 1980s that showed the drug’s hazardous potential.

A spokesperson for GSK said the company could not comment on the specifics of the litigation, but that they take the issue very seriously as patient safety is their utmost priority.

 

Zantac MDL Moves Forward Amid COVID-19 - Unique Team of Plaintiffs' Attorneys Selected For Leadership 

May 13, 2020 - Following setbacks due to the COVID-19 crisis, the legal battle against Zantac has resumed. The Southern District of Florida has appointed an unusually large and diverse team of plaintiffs' leadership to spearhead the multidistrict litigation—26 lawyers now sit on leadership in the Zantac lawsuit.

The timeline of the litigation process was put into question when the coronavirus outbreak began in early April. However, the overseeing judge, the honorable Robin L. Rosenberg, insisted on pushing the case forward via videoconferences. A temporary defense team was created to carry on with litigation. Plans for a status conference on March 20 were canceled in wake of the shutdown, and the conference was postponed until May 12.

Zantac, the popular heartburn drug, has been criticized for containing high levels of NDMA, a cancer-causing chemical. The Food and Drug Administration finally asked all makers of Zantac and its generics to pull the product from shelves on April 1.

More than 140 Zantac lawsuits have been filed for injuries believed to be caused by the drug. The Florida court system consolidated the lawsuits in February, focusing on NDMA and a lack of appropriate warnings from manufacturers.

The 26-person team that has been selected to lead the litigation is almost equal in terms of gender - a rather progressive notion, given that leadership roles are usually appointed more often to male attorneys. Judge Robin L. Rosenberg said that she wanted a diverse team that would match the diversity of those who have been injured by Zantac.

The videoconferences and large team of plaintiffs make the Zantac lawsuit unique in the world of multidistrict litigation.

TorHoerman Law will provide additional updates to the Zantac MDL as the Zantac lawsuit progresses.

 

Ranitidine Cancer Lawsuits Continue in Florida Courts Following Zantac Recalls

February 10, 2020 – 15 Zantac lawsuit plaintiffs have been transferred to South Florida court, where multidistrict litigation has been filed on behalf of individuals who have been diagnosed with cancer subsequent to taking Zantac and similar ranitidine products.

According to the transfer order, which was approved by federal judges, there are currently 126 cases pending in 21 districts nationwide. With the increasing number of Zantac recalls and Zantac-like product recalls across the nation, the Southern Florida court could potentially see a major surge in the number of Zantac lawsuit cases to follow.

The Zantac lawsuit MDL currently consists both of individual plaintiffs alleging personal injury and punitive damage class action lawsuits.

Plaintiffs in the lawsuits claim that Zantac and similar products contain a dangerous quantity of potential carcinogen, NDMA. The FDA in September confirmed the presence of NDMA in Zantac and ranitidine products.

The FDA’s announcement was followed by a number of voluntary recalls of the drug.

Plaintiff injuries include liver cancer, bladder cancer, and other types of cancer, which they attribute to NDMA in Zantac. According to the filings, plaintiffs accuse manufacturers, sellers and distributors of knowingly putting consumers at risk and actively hiding Zantac dangers from consumers.

U.S. District Judge Robin Rosenberg has been assigned to preside over the Zantac lawsuit, which is filed in the U.S. District Court for the Southern District of Florida.

 

Major Zantac Seller Down $186M Amidst Lawsuits

February 17, 2020 - Sanofi, one of the largest pharmaceutical companies in the world, has taken a $186 million write-down on Zantac after recalling the drug back in October. Sanofi is part of a growing list of companies who’ve been hurt by the mass recall.

This past quarter, Sanofi’s consumer health sales dropped 12.8% in the US, 11.7% in Europe, and 5.2% worldwide. The company attributes the decline to Zantac but expects to recover by mid-to-late 2020.

Two years ago Sanofi bought Bioverativ for $11.6 billion, but the investment cost them $1.31 billion in a matter of months. The Bioverativ and Zantac losses have new CEO Paul Hudson focusing his attention on Dupixent, an eczema drug, as well as certain cancer medications.

The following companies have now recalled a version of Zantac:

  • Sanofi
  • Golden State Medical Supply
  • Novitium Pharma
  • Amneal
  • Northwind Pharmaceuticals (a.k.a. Denton Pharma)
  • Sandoz (pharma division of Novartis)
  • Appco Pharma
  • Apotex
  • Perrigo
  • Lannett Company
  • Aurobindo

In addition, Walgreens and CVS no longer sell Zantac.

 

New Zantac Lawsuits Cover Stomach Cancer, Colon Cancer, and More

January 29, 2020 - New lawsuits are emerging as the public learns more about the alleged adverse effects of taking Zantac, a popular heartburn drug. Victims are now claiming it has caused stomach cancer, colon cancer, and even leukemia. These are in addition to the already-extensive list of illnesses being attributed to the drug.

Just a few months ago, the FDA warned the public that ranitidine, commonly sold under the name "Zantac," has been found to contain unsafe levels of the carcinogen N-nitrosodimethylamine (NDMA). Since then, at least nine different companies that sell Zantac or a generic version of Zantac have voluntarily issued recalls for the drug.

Interestingly, NDMA is no longer made in the US. The FDA believes the NDMA found in Zantac is just a chemical impurity, but some plaintiffs are arguing that NDMA is actually formed in the body upon consumption. The latter suggests anybody could be injured by the drug, regardless of where or when they bought it.

If you've taken Zantac and suffered injuries of the lungs, kidney, liver, or stomach, consider speaking with a personal injury attorney or even filing a Zantac injury lawsuit.

 

Researchers Find NDMA in Zantac Can Develop During Storage

January 9, 2020 - 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.

 

3rd Generic Zantac Drug Recalled in One Week

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.

 

FDA Investigates Zantac Cancer Risks, Issues Consumer Warning

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.

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References

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/.

Ariza, Mario, and Sun Sentinel. “141 Suing over Zantac Cancer Concerns Likely to Be Just the Beginning.” Herald, 22 Feb. 2020, www.heraldmailmedia.com/news/nation/suing-over-zantac-cancer-concerns-likely-to-be-just-the/article_b0ac668d-3dad-5e9a-b823-a02c0918211b.html.

Blankenship, Kyle. “Sanofi Takes $186M Hit on the Heels of Zantac Recall.” FiercePharma, Questex LLC, 6 Feb. 2020, www.fiercepharma.com/manufacturing/sanofi-takes-a-big-financial-hit-after-recall-contaminated-zantac.

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Last Modified: November 20th, 2020 @ 10:21 am

What is the Zantac Lawsuit?

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).