The U.S. Food and Drug Administration (FDA) recently released a statement alerting healthcare providers and patients of a discovered NDMA impurity in ranitidine, which is the active ingredient in brand-name Zantac and generic ranitidine drugs.
For decades, Zantac has been widely used across the world for conditions such as heartburn, gastroesophageal reflux disease (GERD), ulcers, and other gastric reflux issues. In the United States alone, an estimated 15 million prescriptions are written for Zantac each year.
However, the recent discovery of NDMA in Zantac—and the popular heart medication, Valsartan—has prompted widespread concern due to a known link between overexposure to NDMA and various cancers.
While the FDA has not recommended that people who are taking Zantac or ranitidine stop taking these drugs, it may be important for those who have taken the drug long-term to understand what NDMA is and the effects of NDMA overexposure on health.
What Is NDMA?
N-nitrosodimethylamine (NDMA) is a chemical that is classified as a “probable human carcinogen” by the U.S. Centers for Disease Control and Prevention (CDC) and other federal agencies.
NDMA is a chemical that can occur naturally and be manufactured through industrial processes—as an ingredient previously used for the production of rocket fuel. The use of NDMA in rocket fuel stopped, however, after dangerous levels of NDMA were discovered in the air, water, and soil outside rocket fuel manufacturing plants.
According to the U.S. Environmental Protection Agency (EPA), the primary ways in which people are exposed to NDMA today are through:
- certain foods (e.g. smoked or cured meats, cheese)
- contaminated water
- toiletry and cosmetic products
- malt beverages
- tobacco smoke
- workplace exposure (i.e. working at tanning salons or manufacturing plants that produce rubber, tires, or pesticides)
Exposure to trace amounts of NDMA is not necessarily poisonous. The FDA recommends a daily limit of 96 nanograms of NDMA per day to avoid serious health concerns, such as liver and kidney damage, internal bleeding, and cancer.
How NDMA Was Found In Zantac
During a round of routine testing in June 2019, the pharmaceutical research company, Valisure, detected dangerously high levels of NDMA in their ranitidine products—far exceeding the FDA-recommended daily limit for NDMA with over 3,000,000 ng in each tablet.
After notifying the U.S. Food and Drug Administration (FDA) of this concern, the company continued to investigate their initial findings and in September 2019 filed a FDA Citizen Petition, requesting that the FDA:
- request a recall of all ranitidine products (e.g. Zantac) in the U.S. and suspend all ranitidine drug sales
- conduct an investigation into the safety of these ranitidine products
- inform the public of the discovered NDMA contaminant in Zantac and its associated health risks
- provide guidance to the public on how to safely dispose of over-the-counter (OTC) and prescription ranitidine products
On September 13, 2019 the FDA released their own official statement formally alerting healthcare providers and patients about the NDMA found in Zantac and the known link between NDMA and cancer.
Unlike a number of countries across the globe, the primary health agency in the U.S. that is responsible for evaluating drug safety (the FDA) has not issued a mandatory recall of Zantac and ranitidine drugs.
However, over a dozen top manufacturers of Zantac and ranitidine—including Sanofi, Pfizer, and Boehringer Ingelheim—have voluntarily pulled their ranitidine products from the market in response to public outcry and test results confirming the presence of NDMA in their drugs.
At this time, a number of entities—including the FDA, pharmaceutical companies, and lawyers—are conducting ongoing investigations into the dangers of the NDMA found in Zantac. These investigations include how many people are estimated to be affected and whether the drugmakers who produced these drugs knew of the NDMA in their products before marketing them for profit.
NDMA Dangers: Symptoms And Side Effects
According to Harvard Associate Professor, Joshua Gagne, NDMA is only likely to increase a person’s risk for cancer and other serious health problems following excessive, long-term exposure.
However, the general likelihood of people developing cancer after taking Zantac (ranitidine) is still unclear. What’s important to know is that taking Zantac once, or infrequently, is unlikely to cause cancer on its own.
Unfortunately, Zantac is commonly used as a long-term treatment for several chronic health conditions, including ulcers, acid reflux, and GERD. If you or a loved one has taken Zantac long-term for a health problem and have since been diagnosed with cancer, there’s a possibility your use of the drug could have contributed to your cancer.
In addition to cancer, NDMA is also associated with a number of other symptoms and health issues that can vary in severity depending on how much of the chemical you’ve ingested. The primary organs likely to be affected by overexposure to NDMA are the kidneys, liver, and lungs.
Symptoms and side effects of overexposure to NDMA may include:
- reduced kidney or liver function
- stomach pain
- nausea and vomiting
- jaundice (yellow skin and eyes)
- enlarged liver
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How NDMA Came To Be In Zantac
One of the primary questions people are asking about the NDMA in Zantac is: How did NDMA get to be in these drugs in the first place?
Zantac is not the first drug in recent years that has been discovered to contain toxic amounts of NDMA. In 2018, the FDA issued a recall for batches of the blood pressure drug, Valsartan, after it was discovered to contain unsafe levels of NDMA. The source of the NDMA in Valsartan is believed to be due to a manufacturing error.
The source of the NDMA in Zantac, however, is still a subject of dispute. While the FDA reports the issue as a contamination in certain ranitidine-containing drugs, multiple researchers have stated that it’s an issue of the chemical structure of ranitidine that causes the body to generate dangerous levels of NDMA once taken.
If the latter scenario is the cause for the NDMA found in Zantac, this may have important implications for whether Zantac products can be safe for present or future use.
Many people who take Zantac for chronic health issues claim Zantac is the only drug that’s been effective in treating their condition. It may be important for you and your doctor to consider whether the benefits of taking Zantac outweigh the potential costs.
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What To Do If You’ve Taken Zantac
If you or a loved one has taken Zantac (ranitidine) for a health condition, don’t panic. The first thing you should do to determine your risk for cancer and other health issues is talk to your doctor as soon as possible.
Many physicians across the country are aware of the recent Zantac recalls and the discovered NDMA impurity. Your doctor can assess your risk for cancer, or determine if your cancer might have been caused by the NDMA in Zantac, by examining your current health status and medical history.
If you’ve been diagnosed with cancer after taking Zantac regularly for a long period of time, you might also consider taking legal action against Zantac manufacturers to seek compensation for losses such as medical bills, cancer treatment, and mental anguish.
If you’ve developed one of the following types of cancer after taking Zantac, you may be eligible to sue Zantac drugmakers:
- liver cancer
- stomach cancer
- lung cancer
- breast cancer
- testicular cancer
- bladder cancer
- pancreatic cancer
- esophageal cancer
- kidney cancer
- cancer of the blood
- colorectal cancer
Pharmaceutical companies must be held accountable for any health risks they expose consumers to without proper warning. At this time, it’s unclear whether drugmakers were aware of the NDMA in their drugs prior to marketing them to doctors and the public.
However, based on available research on the effects of ranitidine in humans—some of which dates back decades—it appears to be very unlikely that the drugmakers were completely unaware of how NDMA could be produced in the body after taking their drugs.
Regardless of intent, these drugmakers may still be held liable for failing to detect the NDMA in their products and for exposing consumers to drugs that could generate dangerous levels of a cancer-causing chemical in the body.
If you’ve developed cancer or other serious health issues after taking Zantac, our attorneys are ready to hear your story. With our legal expertise, we can determine whether you’re eligible to join others in filing an individual or class action lawsuit against Zantac drugmakers.
Don’t wait. Call the offices of Florin|Roebig today to schedule a free consultation with one of our award-winning pharmaceutical attorneys.