BREAKING NEWS: The FDA has launched a recall of Zantac and all ranitidine drug products. An investigation revealed that ranitidine drugs (which are sold under the brand name Zantac as well as generics) contain an impurity that may result in increased cancer risk.
The impurity that poses a danger to consumers is N-Nitrosodimethylamine, or NDMA. Identified by the World Health Organization as a probable carcinogen to humans, long-term and cumulative exposure to NDMA increases the risk of a wide variety of cancers.
Diverse everyday sources contain low levels of NDMA that are deemed safe, from drinking water to meats, fish, and cheese, as well as certain medications. Previous testing of ranitidine products, including Zantac, found unsafe levels of NDMA that compelled drugmakers to launch voluntary recalls of affected products. This included Sanofi, the manufacturer of Zantac.
On April 1, 2020, the FDA updated its guidance on Zantac and requested that manufacturers “withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately.” This update was based on additional research conducted by the FDA and independent testing laboratories, which found that:
“NDMA levels increase in ranitidine even under normal storage conditions, and NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers. The testing also showed that the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA. These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit.”
Based on this additional information, the FDA is now recommending that individuals stop taking Zantac. While there are still questions to be answered regarding the cancer risks associated with Zantac, at this time the FDA does not consider Zantac safe to use.
A volatile organic compound, NDMA breaks down when exposed to light and heat. As a result, NDMA toxicity increases over time.
Zantac is advertised as an OTC remedy for heartburn, which some individuals experience every day. For individuals with ulcers or gastroesophageal reflux disease (GERD), ranitidine was available by prescription for daily use.
Given the current information, it is possible that long-term users of Zantac or generic ranitidine could be at significant risk of developing cancer from cumulative NDMA exposure.
The attorneys at Dreyer Boyajian LLP are monitoring the recall and other developments as they arise concerning Zantac and ranitidine. We discuss questions and issues concerning this recall in the sections below. If you have any questions for our law firm, please don’t hesitate to contact us online or by phone at (518) 463-7784.
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.
The FDA recommends that individuals no longer take Zantac due to the cancer risk associated with NDMA. While it isn’t yet known what exposure level is necessary in order to present a risk for cancer, the risk is high enough that the FDA has advised patients to stop taking Zantac and instructed manufacturers to pull all prescription and OTC Zantac from pharmacy shelves.
Is Zantac bad for you? At this point, the answer appears to be “Yes.” While not everyone who has consumed Zantac will develop cancer as a result, the risk is high enough to consider Zantac unsafe for use at this time.
Zantac is now known to be dangerous as a result of the fact that it contains high levels of N-nitrosodimethylamine. 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, with levels increasing over time even when the drug is stored under normal conditions. Sanofi, which manufactures Zantac in the United States, is legally responsible for exposing Zantac users to the risk of cancer through NDMA.
The cancer risk associated with Zantac is the result of the presence of N-Nitrosodimethylamine. NDMA is a contaminant that results from impurities in ranitidine, which is the generic form of Zantac.
NDMA is classified as a “probable human carcinogen” (a substance that can cause cancer). Studies have shown that Zantac can contain levels of NDMA that are significantly higher than those recommended for safe human consumption.
NDMA, a contaminant found in Zantac, is classified as a “probable human carcinogen.” This means that it has the ability to cause cancer in humans if consumed at sufficient levels.
The Environmental Protection Agency (EPA) has published a Technical Fact Sheet on NDMA which states:
As exposure to NDMA in sufficient levels can cause various forms of cancer, the symptoms of cancer resulting from Zantac consumption vary widely. As a result, if you have any concerns for any reason, you should consult with your doctor promptly.
According to the National Cancer Institute, the following are all general symptoms of cancer. However specific cancers may have additional symptoms as well. The National Cancer Institute recommends seeing a doctor if any of these symptoms last for a couple of weeks or longer:
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:
At this point, it still isn’t clear exactly how much Zantac an individual must consume in order to be at risk for developing cancer. As Harvard Medical School explained in a recent article on its blog, “Although classified as a probable carcinogen, NDMA may cause cancer only after exposure to high doses over a long period of time.” The article goes on to note that “As the FDA and other agencies around the world continue to investigate ranitidine, more details will become available.”
In terms of what constitutes a “high dose,” a standard Zantac tablet is 150 milligrams. Most individuals who have been prescribed Zantac were advised to take two tablets daily. A February 2021 article from Verywell Health notes that “a 150-milligram (mg) dose of ranitidine increases the urinary excretion of NDMA by over 400-fold — a rise from 110 nanograms (ng) to 47,600 ng.” The article also notes that “These levels are alarming, but they still don’t mean that you will get cancer due to this level of exposure. Right now, scientists simply don’t know.”
Zantac is manufactured by Sanofi in the United States under license from GlaxoSmithKline. As of May 2021, Bloomberg reports that Sanofi is facing lawsuits from more than 70,000 individuals related to the company’s failure to disclose the cancer risks of NDMA-contaminated ranitidine.
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.
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.”
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.
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:
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.
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:
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.
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.
The FDA recommends that individuals who take OTC Zantac should stop taking the medication and not buy more. Although the FDA also recommends disposing of any tablets you currently have, it is important to hold on to medications and packaging in your possession if you believe you have a claim against the manufacturer.
For those who are taking prescription ranitidine medications, the FDA recommends speaking with their doctor prior to stopping use of Zantac.
There are several alternatives to Zantac. According to the FDA, the following OTC medications are approved for “the same or similar uses as ranitidine [but] do not carry the same risks from NDMA”:
Of course, before beginning any course of medical treatment, even with an over-the-counter medication, you should consult with your doctor. If you are currently taking prescription ranitidine, you should consult with your doctor about the options you have available.
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.
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:
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.
If you or a member of your 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 contact us online and one of our attorneys will be in touch shortly.