Even though its sales had fallen off due to increased competition, Zantac (Ranitidine) was once one of the highest-selling drugs in the country. For a time, people associated relief from heartburn and gastroesophageal reflux disease with taking Zantac even though it is not designed to be used as a fast-acting means of relief.
Now, they can no longer reach for this heartburn remedy as it has been recalled and pulled from the shelves by the U.S. Food and Drug Administration. Instead of reaping outsize profits from their medication, the makers of Zantac are now facing lawsuits because Zantac has been found to contain a carcinogen.
Much is still being learned about the extent of the contamination, but plaintiffs have come forward with lawsuits claiming that they took Zantac and developed cancer.
Connection Between Zantac and Cancers in the Digestive Tract
If you or a family member has taken Zantac or Ranitidine and have now been diagnosed with cancer, you may be eligible for substantial financial compensation. Our legal team is reviewing cases involving the following cancers:
- Stomach cancer
- Bladder cancer
- Colon cancer
- Liver cancer
- Breast cancer
- Pancreatic cancer
You would need to file a lawsuit against the makers of Zantac in order to begin the legal process that could result in your compensation.
The attorneys at the Drug Law Center LLC can fight for you if you have taken Zantac and now have cancer. We are experienced product liability lawyers who have taken on some of the nation’s biggest corporations. Let us fight for you.
What Is Zantac and What is it Prescribed for?
Zantac had been a go-to remedy for those who have heartburn or acid reflux for nearly four decades. Zantac is the most well-known and best-selling of a class of drugs called ranitidine.
It was developed in 1981 and was a mainstay in the United States market for almost 40 years. By the end of its first decade on the market, Zantac reached $1 billion in annual sales. At one time, Zantac was the best selling drug in history.
Zantac was eventually surpassed by proton pump inhibitors such as Nexium that soon took over the top spots as the highest-selling drugs. At the time that Zantac was pulled from the market, it’s annual sales were a fraction of what they were at its peak, with sales figures of just over $125 million in a year.
Generic versions of the medication have also eaten into Zantac’s sales figure. Everything that you see written here applies to both Zantac and generic versions of the drug.
Zantac is made by Sanofi. Glaxo was also a large player in the ranitidine market, but Sanofi made the original flagship product. They acquired the rights to distribute the product in the U.S. in 2017. Sanofi originally took Zantac off the market in October 2019.
When it comes to legal liability for cancer caused by Zantac, anyone who has taken the drug may receive compensation if they have gotten sick. It does not matter if they took Zantac years ago and no longer use the medication.
How Does Zantac Work?
In general, Zantac is a histamine type 2 receptor antagonist. The medicine is intended to prevent the secretion and production of acid. The way that Zantac works is that it binds itself to the H2 receptor as a means of inhibiting stomach acid.
In many ways, this cuts off stomach acid at its source and keeps it from being produced in the first place.
Zantac is taken in tablet form and is part of a course of treatment to reduce stomach acid. Patients take Zantac up to twice a day and use the medicine over a period of four-to-eight weeks in order to see signs of improvement.
The drug comes in both prescription and OTC strength. The prescription medication is a higher strength of the over-the-counter version. The lower dose medication is used for heartburn and indigestion.
The higher strength medicine is intended to treat more acute cases of gastrointestinal reflux disease.
What Went Wrong With Zantac?
In order to fully understand the issues with Zantac that have led its removal from the market, it is necessary to understand some of what has been happening recently with other medications. Contamination in medications has been at the forefront in the past 18 months.
Previously, a blood pressure medication called Valsartan was pulled from the market due to contamination concerns. The specific problem was that there was a substance called NDMA that was found in the medication. When NDMA is consumed at certain levels, it has been determined to be a ‘probable human carcinogen’ by the World Health Organization.
With Valsartan, NDMA was introduced into the medication during the manufacturing process. Valsartan was made in China and India, and there was an issue after a change in manufacturing that caused the medication to become contaminated.
As a result of the presence of NDMA, patients who took the medication and were diagnosed with cancer have filed lawsuits (Multi-District Litigation and Class Action) against the makers of the drug.
Why NDMA Contamination is Such a Big Problem
The problems with Valsartan have caused regulators to closely scrutinize other medications to make sure that they were free of NDMA. Since there have been suspicions for years that ranitidine medications could contain NDMA, regulators tested Zantac and other medications in its class for NDMA.
This was done after private parties had performed their own tests and passed the results along to the FDA.
The results of the tests showed that ranitidine products contained NDMA. At first, the FDA indicated that the levels of NDMA in Zantac were low, even though they were still over the recommended daily limit for NDMA exposure.
With that in mind, the FDA did not immediately order that Zantac be removed from the market. Instead, the regulator advised the public that it was continuing to monitor the situation.
Zantac Recall by Drug Manufacturers & The FDA
Makers of Zantac and other ranitidine medications did not wait for the FDA to take action. Instead, they were cautious and took matters into their own hands.
Manufacturers initiated a series of voluntary recalls of the medications. In addition, large pharmacy chains such as CVS also removed the products from their store shelves. Within a couple of months, it became nearly impossible to find ranitidine in any store.
Months after the FDA initially indicated that there was an issue with Zantac, it finally requested that makers of the product fully remove it from circulation, notwithstanding the fact that most of them had already voluntarily recalled it.
Moreover, the FDA requested that patients stop taking Zantac. This marked the end of ranitidine products after over four decades.
Zantac May Have Dangerously High Levels of NDMA (A Known Carcinogen)
As we mentioned, the FDA originally believed that Zantac did not contain very high levels of NDMA. It tested numerous batches of the medicine and the test results varied between batches.
However, private testing of Zantac revealed a different picture that shows levels of NDMA that are dangerous. Valisure is a private pharmacy that prides itself on thoroughly testing medications that it sells.
It performed its own analysis on Zantac. It was Valisure that was the entity that performed the original tests that detected the presence of NDMA in Zantac.
Based on its results, Valisure filed a citizen petition with the FDA in September 2019 asking for the recall of Zantac.
Valisure performed a variety of recent tests on Zantac. When it looked at NDMA levels in an environment that replicated stomach conditions, it found NDMA levels that were 3,000 times higher than the level that the FDA set as tolerable for another type of medication.
Valisure’s test results painted a bleaker picture of the NDMA content than the FDA’s original tests that stated that NDMA levels were “low.” In November 2019, the FDA alerted the public that the NDMA measures in Zantac were “similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.” However, this testing does not capture the entire picture.
What You Need to Know About NDMA and the Cancer Correlation
NDMA is an organic compound whose scientific name is N-Nitrosodimethylamine.NDMA can be a byproduct of certain processes. For example, NDMA can be produced during water treatment. It can also be formed during the process when meat is being cured and smoked.
Even rocket fuel can be formed from NDMA. The compound has even been used as a poison on some occasions.
NDMA is a known carcinogen in lab animals. When it comes to humans, the issue is a little more complicated. Nearly all people are exposed to NDMA in their daily lives.
However, there is a safe level of NDMA that people can ingest with a lower risk of contracting cancer. It is only when the allowable levels are exceeded that people are at risk.
Scientists claim that people face the most risk when their exposure to NDMA above the allowable levels is prolonged. This is exactly what happens when the person takes the medication on a daily basis for years.
There have been numerous instances recently in which NDMA has been discovered in medications. This has led to their removal from the market out of concern that patients could develop cancer from prolonged exposure.
How Did NDMA Get Into Zantac?
The issue with the Zantac contamination is different from the Valsartan problems. As opposed to an impurity being introduced into the medication during the manufacturing process via a chemical reaction, ranitidine’s problems occur naturally due to the composition of the drug.
There are several different theories of how Zantac gets contaminated. The first centers around the instability of ranitidine. The thought is that Zantac produced the NDMA on its own over time as the properties of the medication changed.
The now-prevailing theory is similar. Researchers believe that the drug changes as it is stored and will develop NDMA at high temperatures. This is why there were test results of different batches that varied greatly in their NDMA content. In this case, it depends on the storage conditions.
However, there are also theories that Zantac converts into NDMA when it is in the stomach and body. Thus, test results will be different if one looks at a batch off of the shelf versus analyzing bodily fluid after taking Zantac.
Zantac Cancer Lawsuits Are Being Filed
The statistics of how many people have taken Zantac over the years are not fully known. What we do know is that this drug achieved tens of billions of dollars of sales over the course of its product life. This means that there are millions of people who may be affected by Zantac contamination.
The first lawsuits have begun to be filed in the Zantac cases. By early March 2020, there were 15 lawsuits that allege Zantac harm. There are lawsuits that are seeking compensation for Zantac injuries as well as class action lawsuits that are attempting to get money back on behalf of purchasers of Zantac.
These cases were transferred to federal court in South Florida. Since the lawsuits were recently filed, there has been no movement on the cases yet. They will take years to go through the legal system. For you, this means that there is still time to file a Zantac lawsuit so long as you bring the case within the applicable statute of limitations.
Did Glaxo, Emery Pharma and Sanofi-Aventis Know of the NDMA Issues with Zantac?
One of the main allegations of the emerging Zantac lawsuits is that Sanofi knew for years of the likelihood that the product could be contaminated with NDMA. However, the drugmaker did not take steps to either take the product off the market or alert the public of the problems with the drug.
In fact, as far back as 1983, there were reports that ranitidine medications could be a cancer risk in laboratory rats. These reports persisted throughout the last decade. Thus, the potential for Zantac to contain NDMA was hardly a secret. In other words, Sanofi knew or should have known that it was selling a dangerous product.
Why You Need a Zantac Cancer Lawyer
One of the major issues in a product liability lawsuit such as the Zantac cases is whether the product actually caused the harm that the plaintiff suffered. In other words, the main question is whether taking Zantac caused the plaintiff’s cancer.
Plenty of people have taken Zantac and many people, in general, have been diagnosed with cancer. The challenge for a Zantac plaintiff is showing that there is a connection between the contamination of the medication and their cancer.
This is where a Zantac lawyer will help you. At the Drug Law Center, we work with scientific experts to help develop and present your case. In this case, you will likely need to show scientific evidence that ties Zantac to your cancer diagnosis.
Have You or a Loved One Been Injured by Zantac? Get Legal Help Now
Call us today to set up your free initial consultation with our attorneys. We will fight to maximize the value of your case and will work closely with you throughout the court of your litigation.
The first step is talking with you to learn the facts and to let you know if you are in a position to seek compensation. You owe us nothing unless we are able to help you receive a financial recovery for your injuries.