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Zantac (Ranitidine) Recalled for Cancer Risk

Zantac Contains Unsafe Levels of NDMA, Which Causes Cancer. If You or a Loved One Has Been Diagnosed with Cancer After Taking Zantac, You May Be Entitled to Financial Compensation.

In September 2019, the U.S. Food and Drug Administration (FDA) found the cancer-causing chemical N-nitrosodimethylamine (NDMA) in tablets of Zantac. Laboratory testing confirmed that Zantac contains levels of NDMA that are significantly higher than what the FDA considers safe.  

Zantac is one of several brand-name versions of the drug ranitidine. Since the FDA released its findings, several pharmaceutical companies have voluntarily recalled their ranitidine products (including Sanofi, the maker of Zantac). Major drug store chains including CVS, Rite-Aid and Walgreens have also pulled ranitidine products from their shelves. If you or a loved one has been diagnosed with cancer after taking Zantac, you may be entitled to financial compensation, and you should speak with an attorney promptly. 

Zantac Overview: What is Zantac, and Why is it Dangerous? 

What is Zantac Used For?

Zantac is a popular medication that has been approved by the FDA since 2004. It is an H2 (histamine-2) blocker, and it works by decreasing the amount of acid created by the stomach. Zantac is available over the counter (OTC) to treat heartburn. It is also available by prescription for the treatment of ulcers, gastroesophageal reflux (GERD) and certain other conditions.

What Makes Zantac Dangerous? 

Zantac is now known to be dangerous as a result of the fact that it contains high levels of N-nitrosodimethylamine (NDMA). The FDA, the Environmental Protection Agency (EPA) and the International Agency for Research on Cancer (IARC) all classify NDMA as a probable human carcinogen.

There is no question that Zantac exposes users to the harmful effects of NDMA, and the FDA is currently in the process of investigating how Zantac introduces NDMA into the body. At present, the FDA is exploring three possible alternatives: (i) Zantac is unstable and breaks down to form NDMA during the digestive process, (ii) NDMA forms in Zantac due to exposure to light and/or heat during storage, or (iii) NDMA is introduced into Zantac during the drug manufacturing process. Regardless of the specific issue, Sanofi, which manufactures Zantac in the United States, is legally responsible for exposing Zantac users to the risk of cancer through NDMA. 

How Dangerous is Zantac?

Zantac has the potential to be extremely dangerous. While not everyone who has consumed Zantac will develop cancer,  exposure to NDMA for only a few months puts people who consume the drug at risk for cancers including: 

  • Bladder cancer
  • Breast cancer
  • Colorectal cancer
  • Esophageal cancer
  • Gallbladder cancer
  • Intestinal cancer
  • Kidney/renal cancer
  • Liver cancer
  • Leukemia
  • Mouth cancer
  • Multiple Myeloma
  • Non-Hodgkin’s Lymphoma
  • Pancreatic cancer
  • Prostate cancer
  • Small intestine cancer
  • Stomach cancer
  • Throat cancer 

What Zantac Users Need to Know about NDMA

What is NDMA Used For?

The cancer risks associated with Zantac result from the fact that the drug contains the chemical N-nitrosodimethylamine (NDMA). 

NDMA is a semi-volatile and combustible chemical compound that is highly toxic. Today, NDMA is used for laboratory research to induce tumors in experimental animals. It was formerly used in several industrial processes, including the production of rocket fuel, lubricants and solvents. The EPA has designated NDMA as a priority pollutant. It is an environmental contaminant that is soluble in water, decomposes when exposed to light, and emits toxic fumes when heated.

While NDMA can be useful in a number of industrial applications, it is not intended for human consumption, and it is not intended for use as an ingredient in any foods, cosmetics or medications. The FDA does not consider extremely low levels of NDMA contamination to be harmful; however, the amount of NDMA found in Zantac and other ranitidine formulations far exceeds the FDA’s recommended limits. 

How Much NDMA is in Zantac? 

According to the FDA, Zantac contains between 3,000 and 26,200 times the level of NDMA that the agency considers safe. In a Press Announcement released on January 8, 2020, the FDA stated that it is, “advis[ing] companies to recall their ranitidine if testing shows levels of NDMA above the acceptable daily intake (96 nanograms per day or 0.32 parts per million for ranitidine).” This Press Announcement followed the FDA’s previous statement of November, 1 2019, in which it provided additional information on the risks of NDMA exposure through ranitidine:

“[C]onsuming up to 0.096 micrograms or 0.32 parts per million (ppm) of NDMA per day is considered reasonably safe for human ingestion based on lifetime exposure. FDA has set the acceptable daily intake limit for NDMA at 0.096 micrograms or 0.32 ppm for ranitidine. Although many manufacturers have already recalled ranitidine voluntarily, FDA will recommend recalls to manufacturers with NDMA levels above the acceptable daily intake limit.”

Is NDMA Approved by the FDA or Other Government Agencies? 

Although the FDA did not initially call for patients taking Zantac to stop doing so, it subsequently updated its guidance to recommend recalls as indicated above. Following this guidance, Appco Pharma LLC and Northwind Pharmaceuticals (which sells drugs manufactured by Glenmark Pharmaceutical Inc.) both voluntarily recalled their ranitidine medications. Sanofi eventually issued a voluntary recall for Zantac in the United States and Canada as well. Anyone who is taking Zantac as an OTC or prescription medication should consult with their doctor promptly. 

NDMA is not approved by the FDA, although it is an ingredient in some approved foods, drugs and cosmetics. This is because the FDA acknowledges that the chemical is not currently considered a health risk in extremely small amounts. In fact, according to the FDA, “NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.” However, while this may be the case, the FDA, EPA and other U.S. and international agencies have all labeled NDMA as a probable carcinogen (a chemical that is likely to cause cancer), and in sufficient quantities it can be hazardous to your health. 

Zantac Complications and Symptoms

What Can Happen if Someone has Taken Zantac? 

Exposure to high levels of NDMA through the consumption of Zantac can expose users to each of the cancers listed above. These cancers have varying symptoms, effects and prognoses. While many patients who are diagnosed with cancer are able to fully recover, cancer also has the potential to be fatal or lead to life-altering complications. 

Aside from the cancer risk associated with NDMA, Zantac can cause a number of other side effects and symptoms as well. These include:

  • Increased risk of developing pneumonia 
  • Constipation or diarrhea
  • Nausea, vomiting or stomach pain
  • Headaches
  • Difficulty sleeping
  • Reduced libido 
  • Feeling weak
  • Loss of appetite 
  • Vision problems
  • Abnormal heartbeat
  • Yellowing of the eyes or skin
  • Severe blistering, peeling or skin rash

Many of these are also potential warning signs of cancer. While individuals who have taken Zantac should not immediately be alarmed if they experience these (or other) symptoms, they should consult with their doctors as soon as possible.  

What are the Short-Term and Long-Term Effects of Taking Zantac? 

The potential short-term and long-term effects of taking Zantac vary depending on whether exposure to NDMA through the drug results in diagnosis with one of the cancers listed above. While some forms of cancer have the potential to be fatal, many forms of cancer are treatable. However, even when it is possible to recover with treatment, cancer treatment can itself have a number of short-term and long-term effects. According to the National Cancer Institute, which is part of the National Institutes of Health (NIH), these include:

  • Alopecia (hair loss)
  • Anemia (low blood cell count)
  • Bleeding and bruising
  • Chronic pain
  • Constipation or diarrhea
  • Fertility issues 
  • Fatigue
  • Flu-like symptoms
  • Infections
  • Inflammation
  • Loss of appetite 
  • Memory loss
  • Nausea and vomiting
  • Nerve issues
  • Sexual health issues 
  • Sleep problems
  • Swelling
  • Urinary and bladder control issues

Long-term a cancer diagnosis can lead to several potentially-serious issues and complications. Depending on the specific type of cancer diagnosed, these can include heart problems, lung problems, high blood pressure, cognitive impairments, physical disabilities, and the need for ongoing treatment or multiple invasive surgeries. 

When Should Someone Seek Medical Attention? 

Anyone who has taken Zantac and who has experienced one or more of the symptoms listed above should consult with their doctor. If your doctor does not already know that you are taking Zantac, you should tell your doctor how long you have been taking the drug, including with what frequency and in what amount. 

In addition, the FDA has issued the following advisory to individuals who are currently taking Zantac:

“Patients taking prescription ranitidine who wish to stop should talk to their health care professional about other treatment options. Multiple drugs are approved for the same or similar uses as ranitidine.”

Ultimately, if you have any concerns about your (or a loved one’s) health, you should not hesitate to seek medical attention. If you do not have a primary care physician or you are not sure what type of doctor you need to see, we would be happy to provide you with a referral. 

How Dreyer Boyajian LLP Can Help 

Experienced Product Liability Attorneys

Our attorneys are available to represent individuals and families in cases against Sanofi related to NDMA exposure through Zantac. Located in New York, we are available to speak with people about Zantac cancer claims nationwide.  

We have significant experience representing clients against major corporations like Sanofi in large-scale, complex litigation and class-action lawsuits. We also have particular experience in cases involving dangerous drugs, dangerous medical devices and other defective products. These cases are unlike ordinary personal injury and wrongful death claims, and asserting your legal rights effectively requires experienced legal representation. 

Proven Results in Complex and Class Action Litigation

Our trial verdicts and settlement results speak for themselves. The following is just a small sampling of some of the recent settlements and verdicts we have secured for our clients:

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Our Contingency-Fee Representation

Our firm is handling all Zantac cancer claims on a contingency-fee basis. . As our client, you do not have to pay anything unless your claim is successful; and, if we win a settlement or verdict on your behalf, your legal fees and costs will simply be deducted from your award. Our representation is truly risk-free, and you are guaranteed to not have to pay anything out of pocket. 

Contact Dreyer Boyajian LLP for a Free Initial Consultation 

If you or a member of our family has been diagnosed with cancer after taking Zantac for any period of time, we encourage you to contact for a free initial consultation. Our attorneys can assess your legal rights; and, if you have a claim, we can file a lawsuit against Sanofi on your behalf. To learn more, call our firm at 518-463-7784, or request a free consultation online and one of our attorneys will be in touch shortly. 

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