Dangerous Zantac Carcinogen Risk Recalls
The American College of Gastroenterology reports that as many as 60 million Americans suffer from heartburn each month. Considering this fact, it is no wonder that drug manufacturers are cashing in on their discomfort. While people who suffer from heartburn can reduce or eliminate their symptoms through dietary changes and stress management, these methods tend only to work over time, and some cases are resistant to non-pharmaceutical treatment.
Zantac is one of many medications used to decrease the symptoms of heartburn and gastroesophageal reflux disease (GERD). Some patients, who take Zantac or its genric version, ranitidine, however, might develop cancer or experience Zantac cancer symptoms. If you or loved one has already taken Zantac learn what your legal options are with an experienced product liability lawyer today.
Pharmaceutical company Sanofi has recalled the heartburn medicine known as Zantac across all markets after the Food and Drug Administration (FDA) determined that the drug has what they call “unacceptable” levels of probable cancer-causing impurities. Zantac is a fairly popular heartburn relief drug that is also known as ranitidine. It is among one of the most recent drugs to have been found to contain carcinogenic qualities. These drugs have the potential to cause any number of severe illnesses and injuries to consumers that take them. Companies such as Sanofi should be held accountable for putting such dangerous products and dangerous drugs on the market and available to consumers that trust that the products they use will not make them sick.
If you have taken Zantac or its generic equivilent, ranitidine, in addition to talking to your doctor about your next steps, please call the Zantac cancer lawyers at the Dolman Law Group or Sibley Dolman for help. As a Zantac patient, there is a potential that the NDMA you consumed could cause you to develop certain types of cancers or other health problems. If so, you have legal rights, such as filing a lawsuit against the manufacturer of ranitidine. We have years of experience helping people just like you, and we’re ready to evaluate your case right now.
Damages for NDMA Exposure from Zantac
The purpose of a Zantac lawsuit is to seek monetary relief for your losses. If you were diagnosed with cancer, experienced Zantac cancer symptoms, or experienced other adverse medical events after taking Zantac, you can seek reimbursement for your damages in the form of a court award or a settlement.
You might be entitled to receive compensation from the makers of Zantac for the following types of damages and more:
- Past and future medical expenses from NDMA exposure
- Past and future pain and suffering (physical and mental) caused by your injuries, as well as the treatment and recovery process
- Past and future wage loss
- Past and future loss of earning capacity
- Past and future loss of enjoyment of life
- Punitive damages, in some cases
What Is Zantac?
Zantac, also known as ranitidine, is a well established and widely used over-the-counter and prescription antihistamine and antacid medicine that falls into a category of drugs called histamine-2 blockers. First introduced in 1981, it was the world’s biggest-selling prescription drug in 1988 before it became available for over-the-counter use. Even though several more effective medications have eclipsed Zantac, it is still widely used and less expensive than the others. It was the 50th most prescribed medication in the United States, with more than 15 million prescriptions in 2016.
This drug works by reducing the amount of acid that the stomach creates in order to help combat heartburn associated with acid indigestion and sour stomach. Zantac is available over the counter but in some cases requires a prescription. Prescription-strength Zantac may be used to treat and to prevent ulcers in the stomach. The drug is sold by numerous companies in both over the counter and prescription-strength versions.
Why Was Zantac Voluntarily Recalled?
A voluntary recall is an action taken by a company to remove potentially dangerous products from the market to protect consumers and limit liability. Voluntary recalls occur when drug manufacturers and distributors carry out their responsibility to keep the public safe from products that are known to present a risk of injury. Distributors and manufacturers can issue a voluntary recall at any time, although sometimes the FDA requests a recall. Either way, the FDA monitors the recall. Voluntary recalls are an alternative to FDA-initiated court action for removing dangerous products from the marketplace.
When a recall is issued, the company has a planned course of action or a recall strategy to determine the depth of the recall, the necessity of public warnings, and the effectiveness of the recall. Realizing the risk associated with even small amounts of NDMA in their ranitidine-based drugs, manufacturers opted to issue a voluntary recall.
Zantac Medication Recalls
The manufacture and distribution of this popular acid reducer came to a halt in September 2019 as the toxin N-nitrosodimethylamine (NDMA) was found in the drug from several different manufacturers. This nitrosamine impurity is a possible human carcinogen, even at low levels, especially if there is repeated exposure over time.
As a result, Sanofi is recalling four of their prescription-only Zantac medicines. These include a syrup, an injection form of the drug, and a tablet version with 150mg and 300mg doses. Voluntary recalls covered Zantac 150, Zantac 150 Cool Mint, and Zantac 75, ranitidine oral solution from Lannett Company, Inc. and Novitium Pharma’s 150mg and 300mg capsules. Between November 2019 and January 2020, an additional eight recalls of ranitidine products were issued.
Other pharmaceutical companies that make ranitidine issued recalls as well, but not all over-the-counter 75mg doses of ranitidine medicines marketed in the U.S. are being recalled or taken off the market because a different company produces them. With many other affordable alternatives for heartburn and ulcers, some manufacturers have recalled their preparations of ranitidine without doing testing based only on the potential for NDMA in the medication. There is also the chance that if not monitored correctly, future batches of Zantac could contain even higher levels of NDMA.
The presence of NDMA in these Zantac medicines is believed to have been caused by issues with Zantac’s manufacturing process and there is an ongoing investigation being carried out to determine the source of these dangerous issues. In the meantime, major chains such as Walgreens, CVS, Walmart, and Rite-Aid have pulled the generic drug from their shelves and healthcare professionals have been advised to stop supplying the drug to patients and return their supplies of Zantac to the manufacturer as a precaution.
Other manufacturers and retailers that have recalled ranitidine include:
- Apotex Corp.
- Sandoz Inc.
- Perrigo Company PLC
- Dr. Reddy’s
Currently, there is not enough scientific evidence for the United States Food and Drug Administration (FDA) to determine how long NDMA has been present in ranitidine. If you currently take this medication or used it in the past, and you think you are experiencing Zantac cancer symptoms, contact your physician and a product liability attorney to determine your course of action.
What Is NDMA?
NDMA is classified as a B2 carcinogen, meaning it’s a probable human carcinogen. In addition to causing cancer, NDMA is a potent hepatotoxin.
NDMA can form during the cooking of foods, especially food such as cured meats and fish because they contain sodium nitrite as a preservative. NDMA is used in aviation and rocket fuel and industrial lubricants. It is also a byproduct of several industrial processes, including gasoline refining and the treatment of wastewater containing nitrogen. Other applications for NDMA include inducing carcinogenesis in laboratory rats for cancer research.
It is also found in:
- Alcoholic beverages
- Rubber products
- Tobacco smoke
Under the federal Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA), NDMA is classified as “extremely hazardous.” Because of this, there are stringent reporting requirements for companies and individuals who produce, store, or use the substance in large amounts.
NDMA Levels Can Change
The FDA began investigating drugs such as angiotensin II receptor blockers, or ARBs for blood pressure and heart failure. They found that specific preparations of these medications contained NDMA and recommended recalls of certain batches. Now they have done the same with Zantac.
Even though NDMA is found in drinking water and even foods like vegetables, fruits, meats, and dairy products, the amount stays low and does not change. Conversely, NDMA impurities found in medications lack testing procedures to ensure there are not more significant amounts of NDMA seeping into their formulas.
It is still unknown how ranitidine was contaminated with NDMA, as found in laboratory tests. Preliminary testing by the FDA shows some samples of Zantac and ranitidine contain higher levels of NDMA than food.
Although human studies are limited, NDMA is listed as a probable carcinogen to both animals and humans. NDMA is considered to be a potential hepatoxic and carcinogen that can cause a number of complications and health risks regarding the liver, bladder, stomach, and many other internal organs. Carcinogens are a danger to your health not to be taken lightly. Consumers that take drugs with carcinogenic ingredients have a significant risk to develop cancers and other debilitating illnesses related to the degradation of cellular DNA. Carcinogens are substances that cause issues with cellular DNA. This can either be done directly by causing damage to the DNA contained within a cell or through the forced replication of a cell that can have an adverse effect on DNA.
There is a possibility that ranitidine is unstable and breaks down on its own to form NDMA. During the period in which Boerhinger Ingelheim and Sanofi manufactured and marketed Zantac, scientific research demonstrated a clear link between ranitidine and NDMA. Specifically, when ranitidine comes in contact with water, it creates a chemical reaction that causes the formation of NDMA. Despite the availability of this information, the drug companies chose not to disclose this risk to the government or to consumers. The evidence also increasingly also indicated that Boerhinger Ingelheim and Sanofi, concealed the Zantac cancer link. This deception occurred when companies made unprecedented profits from Zantac, according to attorneys.
The amounts of NDMA in Zantac and other medications can change under certain conditions like warmer or cooler temperatures, however. A study published in Carcinogenesis shows that people who take ranitidine have high levels of NDMA in their urine, suggesting that it is created in the body. Studies have shown that when ranitidine mixes with the gastric fluid and sodium nitrites that stimulate the digestion process, high amounts of NDMA are produced. Exposure to simulated stomach conditions caused ranitidine to produce approximately 304,500 ng of NDMA per tablet. The FDA-approved acceptable amount of NDMA intake is 96 nanograms (ng) per day.
This makes it challenging to determine how much NDMA patients are exposed to when they take Zantac, especially if they use the drug on an ongoing basis.
It is also possible that generic versions of Zantac are contaminated with NDMA when manufactured in other countries without strict quality control standards.
The Food and Drug Administration reports that its independent testing has shown that the heartburn medications Pepcid, Tagamet, Nexium, Prevacid, and Prilosec do not contain the chemical NDMA.
NDMA Linked to Certain Cancers
The concern with NDMA is that it can potentially cause cancer, even in small amounts. The longer the exposure to this carcinogen, the higher the chances are for developing cancer and other health problems such as liver disease. Rodent studies revealed a consistent carcinogenic effect of NDMA. The rate of hepatic, pulmonary, and renal tumors has been shown to increase in rodents with inhalation of NDMA and consumption in drinking water containing NDMA.
NDMA is one of the most potent animal carcinogens known to date. It has proven to be a potent carcinogen for all species that were studied, both as single doses and with long-term exposure to smaller quantities. Of note, NDMA seems to be metabolized in the same way in human tissue and rodent tissue. Because of this, the International Agency for Research on Cancer (IARC) classifies NDMA as probably carcinogenic to humans (Group 2A), highlighting that, for practical purposes, NDMA should be viewed as if it were carcinogenic to humans.
As a result of damage to a cell’s DNA caused by exposure to carcinogens, many people suffer severe illness and injury typically in the form of cancer. It goes without saying that cancer is one of the worst maladies that a person can suffer. Many families and even communities feel great pain as a result of loved ones being diagnosed with cancer. Even more mild forms of cancer require treatments that can be exceptionally painful and costly for those affected. It is because of this that there is personal injury law and the ability to seek compensation for these health issues through a defective drug product liability claim when they are caused by a product maker’s negligence.
Types of Injuries Related to Zantac
- Arrhythmia or tachycardia
- Bladder cancer
- Brain cancer
- Cancer in the small and large intestines
- Colorectal cancer
- Esophageal cancer
- Intestinal cancer
- Kidney cancer
- Liver cancer
- Liver Failure
- Lung cancer (if you have never smoked)
- Multiple myeloma
- Nervous System Disorders
- Non-Hodgkin’s lymphoma
- Ovarian cancer
- Pancreatic cancer
- Prostate cancer
- Stomach cancer
- Testicular cancer
- Throat/nasal cancer
- Thyroid cancer
- Uterine cancer
- Vitamin B-12 Deficiency
Breast cancer deserves some detailed attention because of the strong correlation between it and exposure to NDMA.
In April 2020, TWELVE years after a study from the Fred Hutchinson Cancer Research center found a connection between Zantac and breast cancer, the FDA finally pulled ranitidine medicines, including Zantac, off the market. Four months earlier, the agency recalled prescription forms of ranitidine by two generic drug companies, bringing the total number of ranitidine recalls to 14 in the past six months, all because of NDMA.
The study, authored by the American Association for Cancer Research and American Society of Preventive Oncology back in 2008, concluded that the “current use of ranitidine may increase risk of hormone-receptor-positive ductal carcinoma,” which is a type of breast cancer. The study found that individuals who regularly took Zantac increased their risk of developing breast cancer by 240 percent compared to those who didn’t.
NDMA Previously Found in Other Medications
MDMA was found recently in many brands of blood pressure and heart failure medicines, leading to recalls. For instance, European and American regulators recalled blood pressure drug valsartan made by China’s Zhejiang Huahai Pharmaceuticals after finding NDMA in samples of the drug.
Angiotensin II Receptor blockers, including Valsartan, Losartan, and Irbesartan, were also recalled for NDMA contamination in 2018. The potentially cancer-causing impurities may have been introduced by recent changes in the manufacturing process for the drugs, and recalls of some ARBs led to shortages of the medications, including valsartan—the generic of Novartis’s Diovan. Novartis in September stopped global distribution of its ranitidine drugs. In studies with these drugs, there did not seem to be a link to an increased short-term risk of getting cancer, but there was an increased risk of some single cancer outcomes observed.
Further studies are warranted, and, until more information is available, many patients are steering clear of Zantac and opting for alternative medications such as Prevacid or Prilosec, which the FDA says are not contaminated with NDMA.
Zantac Injury Symptoms
NDMA can cause other severe health risks besides the risk of cancer. Overexposure to NDMA can cause jaundice, nausea, fever, vomiting, abdominal cramps, and dizziness. High levels of exposure can cause the impaired function of the kidneys, lungs, and myocardium. NDMA exposure can also cause severe liver damage and gastrointestinal hemorrhage.
If you or someone you love takes Zantac or did in the past, it is crucial to be aware of cancer symptoms. Knowing these symptoms can potentially save your life. Other common Zantac cancer symptoms include:
- Unintentional weight loss
- Poor appetite
- Nausea or vomiting
- Bloody or tarry stools (an indicator of intestinal bleeding)
- Light-colored or greasy stools
- A change in bowel habits
- Symptoms of anemia such as fatigue, dizziness, and weakness
- New abdominal pain unrelated to heartburn
- Back pain
- Yellowing of the skin or eyes
- Dark urine
- Blood in the urine
- Urinary urgency or incontinence
- Painful urination
- Itchy skin
If you are experiencing any of these Zantac cancer symptoms, see your doctor as soon as possible. Additionally, you will want to consult a product liability attorney if you have a history of prescription or over-the-counter use of Zantac or ranitidine.
What Are Your Chances of Getting Cancer From Zantac?
NDMA exposure is suspected to increase the risk of several different cancers, includingtongue, esophagus, lung, pancreas, liver, kidney, and bladder cancers. You should discuss your concerns about getting cancer from the use of Zantac with your doctor. There is no formula to determine what your risk might be. However, through animal testing, it is known that the higher doses and the longer exposures to NDMA increase the risk of test animals getting cancer. The incidence of liver tumors increased, and survival rates decreased in a dose-dependent manner when studied in lab rodents.
The FDA has requested that companies recall their ranitidine if testing shows levels of NDMA higher than the acceptable daily intake of 96 ng or 0.32 parts per million for ranitidine. Although the FDA advisory states that the level of NDMA contamination is minimal in Zantac, some levels were 3,000 to 26,000 times more than what the FDA says is safe.
- Testing determined a single Zantac tablet has nanograms of NDMA when the daily recommended limit is 96 nanograms.
- That is 3,171 times more than the FDA’s recommended daily limit
- In 2016, Zantac was the 50th most prescribed medication in the United States
- More than 15 million prescriptions for Zantac were given every year from 2012-2017
The first Zantac lawsuit was filed in the U.S. District Court for the Northern District of California in 2019. In this lawsuit, the plaintiffs accused big pharma companies Sanofi and Boerhinger Ingelheim of manufacturing, marketing, and selling a product they knew, or should have known, was contaminated with an industrial chemical known to cause cancer. This California Zantac lawsuit has given way to hundreds of others.
In late 2019, a Florida woman filed a Zantac breast cancer lawsuit against four manufacturers, alleging that ranitidine-containing Zantac caused her breast cancer. Jill Goldstein, 44, of Boynton Beach, took the over-the-counter medicine Zantac for nearly two decades. According to the Palm Beach Post, Goldstein’s lawsuit alleges that Zantac is what caused her cancer.
In Colorado, a man claims that Zantac caused him to have bladder cancer. He filed his lawsuit against Sanofi, Boehringer Ingelheim, Pfizer, and GlaxoSmithKline in late 2019. The defendant in this case says that he took Zantac 4 times a week starting in 1996 before he was diagnosed with bladder cancer in 2018.
According to this Colorado Zantac lawsuit, the manufacturers knew of the high levels of NDMA since at least 1981.
Many Zantac lawsuits and Zantac class-action lawsuits, have already been filed in courts nationwide, claiming that the manufacturers knew or should have known about the presence of NDMA in their products, yet they failed to warn consumers or healthcare providers.
When a drug company does or fails to do something that they know or should have known would cause harm to their consumers, they are negligent. Zantac lawsuits are founded on this negligence and seek compensation for any drug-related injuries that patients suffered.
Product Liability and Dangerous Drugs
When something is found wrong with a drug much like with what is happening with Zantac, there is usually a recall to help avoid the further increase of possible injury among consumers. However, these recalls tend to occur after many people have suffered sufficient exposure to dangerous drugs to cause them to develop a severe injury. In this case, those that have suffered severe injuries because of a drug that was defective either because of its design, manufacturing, or insufficient warning labeling, can seek compensation for their injuries through a product liability claim.
It is not unusual for drugs such as Zantac to be defective in some way and injure consumers. There are many drugs that have been found to cause a number of severe injuries to consumers over the years because of issues with design, manufacturing, or labeling. In order for someone to seek compensation because of a defective drug like Zantac, they must first have suffered an injury because of its use. A provable injury is the cornerstone of any personal injury claim, let alone a defective drug claim.
Filing a Zantac Cancer Lawsuit
Next, there must be a party liable for the injury that a consumer has suffered. In this case that liable party could potentially be the maker of Zantac, Sanofi. In order for a party to be considered liable for the injuries that a person suffered because of defective drugs, that party would have to have a duty of care to the consumer which Sanofi does for its customers. In addition, that party must be found negligent which means that they must have had some ability to prevent the problems caused by their product because of a foreseeable problem that was left unaddressed.
If these criteria are sufficiently satisfied then a person may be able to seek compensation for damages caused by defective drug exposure such as medical expenses, lost wages, disability, as well as pain and suffering. A claim can be filed to show that a consumer has a right to compensation because of provable injuries tied to the liable party’s negligence. After that negotiations can begin to determine a settlement between the two parties. If a settlement can’t be reached then the matter will go to court where a jury will decide whether compensation is owed to a plaintiff.
Recent Zantac Lawsuit News Developments
So far, a number of different pharmaceutical companies that produce Zantac drugs have taken these products off of the market due to the risk they pose. As a result, these companies like the french major pharmaceutical company, Sanofi, have taken immense losses to their bottom line reaching hundreds of millions of dollars.
In addition to this, Zantac lawsuits have reached sufficient numbers that the Judicial Panel on Multidistrict Litigation or JPML has determined that Zantac lawsuits should be centralized in Florida’s Southern District. The action comes as a result of both plaintiffs and defendants of these Zantac injury cases calling for the consolidation of federally filed Zantac lawsuits before one court.
Should You Stop Taking Zantac?
If you took Zantac or ranitidine, you might be wondering what your future holds or if you will experience Zantac cancer symptoms. You may have pressing medical and even legal questions.
The FDA recommends that anyone wishing to stop their use of Zantac or ranitidine speak to their physician first. Their physician can advise them of alternative therapies and the potential risk for developing cancer from Zantac, and Zantac cancer symptoms to watch for. You should make your decision to stop taking Zantac with your physician. You will want to see your doctor to determine alternate drug therapies, your risk of getting cancer from Zantac, and any symptoms of which you should be aware. The Food and Drug Administration wants patients to know that its own independent testing reveals that the heartburn medications Pepcid, Tagamet, Nexium, Prevacid, and Prilosec do not contain the chemical NDMA.
Additionally, you should seek legal advice from an experienced product liability lawyer to learn about what rights you have.
How a Zantac Cancer Lawyer Can Help You
If you believe your cancer was caused by Zantac or ranitidine you may need the help of a Zantac Cancer Lawyer. In order to pursue your case, your Zantac lawyer will help you to prove three things:
- That you used Zantac or ranitidine,
- That you have cancer,
- And that the two are connected.
Proving that you used Zantac or ranitidine. Those who are interested in pursuing a cancer lawsuit caused by Zantac will of course have to first prove that they actually took the medication Zantac or ranitidine. The easiest way to prove this would be to contact your doctor or pharmacy to get records of your prescriptions. If you bought the medication over-the-counter, it may be a little hard to prove that you took the medication but, through the help of your lawyer, it can be done using receipts and statements from your doctor.
Proving that you have cancer. Zantac and ranitidine are most commonly known to be harmful in the sense that they could cause cancer. So in order to file a lawsuit, you will not only have to prove that you have cancer but that the type of cancer you have is linked to NDMA. These two stipulations can easily be achieved with the help of your lawyer, doctors, and medical experts.
Proving that the two are connected. Proving that your consumption of Zantac or ranitidine are linked is where all lawsuits get tricky. Generally, there is information, studies, and experts that can all testify to the fact that the two are linked. But you must also show that you consumed enough of the medication for it to have been dangerous. There are two things that can help prove that your consumption of Zantac caused your cancer: how much of the medication you took and how long you took it. The longer you took the medication, and the more of it you took, the more likely it is that your cancer and your consumption of the drug are connected.
“Until all this is resolved, and we have an explanation for why NDMA is present, it’s possible there could be some associated risks with long-term use,” states Emeran A. Mayer, M.D., a gastroenterologist and the co-director of the CURE Digestive Diseases Research Center at UCLA Health in Los Angeles.
Your legal and medical expert team will help to develop the connection between your cancer and contaminated Zantac. This is why you need an experienced Zantac cancer lawyer on your side.
Contact Our Experienced Drug Injury Attorneys
When you are suffering from an ailment, like heartburn or a headache, you have right to assume the OTC medication in your cabinet is safe. Additionally, if you seek treatment from a medical professional and they prescribe you a medications, you have a right to assume that what you are taking is safe and will work as intended. Unfortunately, this is not always the case, and each year, people are injured by defectively manufactured or developed prescription drugs. In some cases, the injury is caused by a medical professional’s negligence in prescribing a particular drug.
Drugs like Zantac have the potential to cause severe injuries to those that use it. The people that suffer these injuries deserve compensation for the damages that they suffered due to the negligence of liable parties that did not take the proper precautions when making such a drug available to consumers. Dolman Law Group can hold these groups accountable for their negligence by recovering settlements for those who have suffered because of this negligence.
If you have been prescribed a medication that you believe may have caused an injury, please contact the attorneys at Dolman Law Group for a free consultation today. You can reach our office by either calling (727) 451-6900 or contacting us online to get the compensation you deserve from a Zantac lawsuit.
Dolman Law Group
800 North Belcher Road
Clearwater, FL 3375