Zantac is one of many medications used to decrease the symptoms of heartburn. In exchange, however, some patients 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. The risk of cancer from Zantac use is simply too great to ignore. We are a law firm focused on holding manufacturers of dangerous drugs responsible for their corporate negligence. It is our earnest belief that Sanofi failed to warn consumers of the unacceptable levels of a potential human carcinogen (substance that promotes formation of cancer).
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.
Valisure, an independent pharmacy conducted an extensive study of ranitidine (generic form of Zantac) in 2019. Their findings illustrated that a single ranitidine tablet contains in excess of 300,000 nanograms of NDMA. To put that in proper context, the acceptable level of NDMA is 96 nanograms per single tablet. Thus, a single dosage of Zantac contained 3000 times the acceptable level of NDMA. Hence, why the the Food and Drug Administration (FDA) pulled all versions of this popular heartburn drugs from shelves on April 1, 2020. The FDA determined the risk of allowing Zantac to remain on the shelves is simply too great to the safety of consumers.
A Brief History of Zantac
Zantac, known as ranitidine in its generic form, is a well established and widely used over-the-counter and prescription medication to fight heartburn. 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.
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.
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 can also be formed during the cooking of foods, especially food such as cured meats and fish because they contain sodium nitrite as a preservative. It is also found in:
- Alcoholic beverages
- Rubber products
- Tobacco smoke
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. It is still unknown how ranitidine was contaminated with NDMA, as found in laboratory tests.
There is a possibility that ranitidine is unstable and breaks down on its own to form NDMA. The FDA-approved acceptable amount of NDMA intake is 96 nanograms (ng) per day. 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.
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 Previously Found in Other Medications
Angiotensin II Receptor blockers, including Valsartan, Losartan, and Irbesartan, were also recalled for NDMA contamination in 2018. 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.
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.
NDMA exposure from ranitidine is also linked to several other cancers such as:
- Stomach cancer
- Cancer in the small and large intestines
- Colorectal cancer
- Esophageal cancer
- Kidney cancer
- Bladder cancer
- Liver cancer
- Prostate cancer
- Pancreatic cancer
- Non-Hodgkin’s lymphoma
- Multiple myeloma
Common Zantac Cancer Symptoms
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. 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.
Zantac Recalls in the United States
Drug manufacturers may issue a voluntary recall to remove products that violate FDA regulations. Recalls protect public health from products that could present a risk of harm or gross deception by the drug manufacturer. 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.
Multiple voluntary recalls have been issued for Zantac and ranitidine drugs. In mid-September 2019, the FDA announced to the public that NDMA was found in ranitidine samples. On September 24, 2019, the first voluntary recall was issued concerning this finding, and Sandoz ranitidine capsules were recalled. Two days later, a voluntary recall was issued for over-the-counter ranitidine tablets (both 75 mg and 150 mg), labeled and sold by Walgreens, Walmart, and Rite-Aid and manufactured by Apotex Corp.
In late October 2019, pharmaceutical company Sanofi announced a voluntary recall of their over-the-counter ranitidine products Zantac 150, Zantac 150 Cool Mint, and Zantac 75. Over the next few days, voluntary recalls were also issued for 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.
Zantac Cancer Lawyer
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 3 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. This connection will be further developed with the help of your legal and medical expert team. This is why it is so important to have an experienced Zantac Cancer Lawyer on your side.
Contact an Experienced Florida Zantac Attorney
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 specializes in holding these groups accountable for their negligence and recovering settlements for those that have suffered because of this negligence. Contact us today to get the compensation you deserve from a Zantac Lawsuit.
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.
Dolman Law Group
800 North Belcher Road
Clearwater, FL 3375